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Immunodeficiencies tied to psychiatric disorders in offspring
new research suggests.
Results from a cohort study of more than 4.2 million individuals showed that offspring of mothers with PIDs had a 17% increased risk for a psychiatric disorder and a 20% increased risk for suicidal behavior, compared with their peers with mothers who did not have PIDs.
The risk was more pronounced in offspring of mothers with both PIDs and autoimmune diseases. These risks remained after strictly controlling for different covariates, such as the parents’ psychiatric history, offspring PIDs, and offspring autoimmune diseases.
The investigators, led by Josef Isung, MD, PhD, Centre for Psychiatry Research, department of clinical neuroscience, Karolinska Institutet, Stockholm, noted that they could not “pinpoint a precise causal mechanism” underlying these findings.
Still, “the results add to the existing literature suggesting that the intrauterine immune environment may have implications for fetal neurodevelopment and that a compromised maternal immune system during pregnancy may be a risk factor for psychiatric disorders and suicidal behavior in their offspring in the long term,” they wrote.
The findings were published online in JAMA Psychiatry.
‘Natural experiment’
Maternal immune activation (MIA) is “an overarching term for aberrant and disrupted immune activity in the mother during gestation [and] has long been of interest in relation to adverse health outcomes in the offspring,” Dr. Isung noted.
“In relation to negative psychiatric outcomes, there is an abundance of preclinical evidence that has shown a negative impact on offspring secondary to MIA. And in humans, there are several observational studies supporting this link,” he said in an interview.
Dr. Isung added that PIDs are “rare conditions” known to be associated with repeated infections and high rates of autoimmune diseases, causing substantial disability.
“PIDs represent an interesting ‘natural experiment’ for researchers to understand more about the association between immune system dysfunctions and mental health,” he said.
Dr. Isung’s group previously showed that individuals with PIDs have increased odds of psychiatric disorders and suicidal behavior. The link was more pronounced in women with PIDs – and was even more pronounced in those with both PIDs and autoimmune diseases.
In the current study, “we wanted to see whether offspring of individuals were differentially at risk of psychiatric disorders and suicidal behavior, depending on being offspring of mothers or fathers with PIDs,” Dr. Isung said.
“Our hypothesis was that mothers with PIDs would have an increased risk of having offspring with neuropsychiatric outcomes, and that this risk could be due to MIA,” he added.
The researchers turned to Swedish nationwide health and administrative registers. They analyzed data on all individuals with diagnoses of PIDs identified between 1973 and 2013. Offspring born prior to 2003 were included, and parent-offspring pairs in which both parents had a history of PIDs were excluded.
The final study sample consisted of 4,294,169 offspring (51.4% boys). Of these participants, 7,270 (0.17%) had a parent with PIDs.
The researchers identified lifetime records of 10 psychiatric disorders: obsessive-compulsive disorder, ADHD, autism spectrum disorders, schizophrenia and other psychotic disorders, bipolar disorders, major depressive disorder and other mood disorders, anxiety and stress-related disorders, eating disorders, substance use disorders, and Tourette syndrome and chronic tic disorders.
The investigators included parental birth year, psychopathology, suicide attempts, suicide deaths, and autoimmune diseases as covariates, as well as offsprings’ birth year and gender.
Elucidation needed
Results showed that, of the 4,676 offspring of mothers with PID, 17.1% had a psychiatric disorder versus 12.7% of offspring of mothers without PIDs. This translated “into a 17% increased risk for offspring of mothers with PIDs in the fully adjusted model,” the investigators reported.
The risk was even higher for offspring of mothers who had not only PIDs but also one of six of the individual psychiatric disorders, with incident rate ratios ranging from 1.15 to 1.71.
“In fully adjusted models, offspring of mothers with PIDs had an increased risk of any psychiatric disorder, while no such risks were observed in offspring of fathers with PIDs” (IRR, 1.17 vs. 1.03; P < .001), the researchers reported.
A higher risk for suicidal behavior was also observed among offspring of mothers with PIDS, in contrast to those of fathers with PIDs (IRR, 1.2 vs. 1.1; P = .01).
The greatest risk for any psychiatric disorder, as well as suicidal behavior, was found in offspring of mothers who had both PIDs and autoimmune diseases (IRRs, 1.24 and 1.44, respectively).
“The results could be seen as substantiating the hypothesis that immune disruption may be important in the pathophysiology of psychiatric disorders and suicidal behavior,” Dr. Isung said.
“Furthermore, the fact that only offspring of mothers and not offspring of fathers with PIDs had this association would align with our hypothesis that MIA is of importance,” he added.
However, he noted that “the specific mechanisms are most likely multifactorial and remain to be elucidated.”
Important piece of the puzzle?
In a comment, Michael Eriksen Benros, MD, PhD, professor of immunopsychiatry, department of immunology and microbiology, health, and medical sciences, University of Copenhagen, said this was a “high-quality study” that used a “rich data source.”
Dr. Benros, who is also head of research (biological and precision psychiatry) at the Copenhagen Research Centre for Mental Health, Copenhagen University Hospital, was not involved with the current study.
He noted that prior studies, including some conducted by his own group, have shown that maternal infections overall did not seem to be “specifically linked to mental disorders in the offspring.”
However, “specific maternal infections or specific brain-reactive antibodies during the pregnancy period have been shown to be associated with neurodevelopmental outcomes among the children,” such as intellectual disability, he said.
Regarding direct clinical implications of the study, “it is important to note that the increased risk of psychiatric disorders and suicidality in the offspring of mothers with PID were small,” Dr. Benros said.
“However, it adds an important part to the scientific puzzle regarding the role of maternal immune activation during pregnancy and the risk of mental disorders,” he added.
The study was funded by the Söderström König Foundation and the Fredrik and Ingrid Thuring Foundation. Neither Dr. Isung nor Dr. Benros reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
new research suggests.
Results from a cohort study of more than 4.2 million individuals showed that offspring of mothers with PIDs had a 17% increased risk for a psychiatric disorder and a 20% increased risk for suicidal behavior, compared with their peers with mothers who did not have PIDs.
The risk was more pronounced in offspring of mothers with both PIDs and autoimmune diseases. These risks remained after strictly controlling for different covariates, such as the parents’ psychiatric history, offspring PIDs, and offspring autoimmune diseases.
The investigators, led by Josef Isung, MD, PhD, Centre for Psychiatry Research, department of clinical neuroscience, Karolinska Institutet, Stockholm, noted that they could not “pinpoint a precise causal mechanism” underlying these findings.
Still, “the results add to the existing literature suggesting that the intrauterine immune environment may have implications for fetal neurodevelopment and that a compromised maternal immune system during pregnancy may be a risk factor for psychiatric disorders and suicidal behavior in their offspring in the long term,” they wrote.
The findings were published online in JAMA Psychiatry.
‘Natural experiment’
Maternal immune activation (MIA) is “an overarching term for aberrant and disrupted immune activity in the mother during gestation [and] has long been of interest in relation to adverse health outcomes in the offspring,” Dr. Isung noted.
“In relation to negative psychiatric outcomes, there is an abundance of preclinical evidence that has shown a negative impact on offspring secondary to MIA. And in humans, there are several observational studies supporting this link,” he said in an interview.
Dr. Isung added that PIDs are “rare conditions” known to be associated with repeated infections and high rates of autoimmune diseases, causing substantial disability.
“PIDs represent an interesting ‘natural experiment’ for researchers to understand more about the association between immune system dysfunctions and mental health,” he said.
Dr. Isung’s group previously showed that individuals with PIDs have increased odds of psychiatric disorders and suicidal behavior. The link was more pronounced in women with PIDs – and was even more pronounced in those with both PIDs and autoimmune diseases.
In the current study, “we wanted to see whether offspring of individuals were differentially at risk of psychiatric disorders and suicidal behavior, depending on being offspring of mothers or fathers with PIDs,” Dr. Isung said.
“Our hypothesis was that mothers with PIDs would have an increased risk of having offspring with neuropsychiatric outcomes, and that this risk could be due to MIA,” he added.
The researchers turned to Swedish nationwide health and administrative registers. They analyzed data on all individuals with diagnoses of PIDs identified between 1973 and 2013. Offspring born prior to 2003 were included, and parent-offspring pairs in which both parents had a history of PIDs were excluded.
The final study sample consisted of 4,294,169 offspring (51.4% boys). Of these participants, 7,270 (0.17%) had a parent with PIDs.
The researchers identified lifetime records of 10 psychiatric disorders: obsessive-compulsive disorder, ADHD, autism spectrum disorders, schizophrenia and other psychotic disorders, bipolar disorders, major depressive disorder and other mood disorders, anxiety and stress-related disorders, eating disorders, substance use disorders, and Tourette syndrome and chronic tic disorders.
The investigators included parental birth year, psychopathology, suicide attempts, suicide deaths, and autoimmune diseases as covariates, as well as offsprings’ birth year and gender.
Elucidation needed
Results showed that, of the 4,676 offspring of mothers with PID, 17.1% had a psychiatric disorder versus 12.7% of offspring of mothers without PIDs. This translated “into a 17% increased risk for offspring of mothers with PIDs in the fully adjusted model,” the investigators reported.
The risk was even higher for offspring of mothers who had not only PIDs but also one of six of the individual psychiatric disorders, with incident rate ratios ranging from 1.15 to 1.71.
“In fully adjusted models, offspring of mothers with PIDs had an increased risk of any psychiatric disorder, while no such risks were observed in offspring of fathers with PIDs” (IRR, 1.17 vs. 1.03; P < .001), the researchers reported.
A higher risk for suicidal behavior was also observed among offspring of mothers with PIDS, in contrast to those of fathers with PIDs (IRR, 1.2 vs. 1.1; P = .01).
The greatest risk for any psychiatric disorder, as well as suicidal behavior, was found in offspring of mothers who had both PIDs and autoimmune diseases (IRRs, 1.24 and 1.44, respectively).
“The results could be seen as substantiating the hypothesis that immune disruption may be important in the pathophysiology of psychiatric disorders and suicidal behavior,” Dr. Isung said.
“Furthermore, the fact that only offspring of mothers and not offspring of fathers with PIDs had this association would align with our hypothesis that MIA is of importance,” he added.
However, he noted that “the specific mechanisms are most likely multifactorial and remain to be elucidated.”
Important piece of the puzzle?
In a comment, Michael Eriksen Benros, MD, PhD, professor of immunopsychiatry, department of immunology and microbiology, health, and medical sciences, University of Copenhagen, said this was a “high-quality study” that used a “rich data source.”
Dr. Benros, who is also head of research (biological and precision psychiatry) at the Copenhagen Research Centre for Mental Health, Copenhagen University Hospital, was not involved with the current study.
He noted that prior studies, including some conducted by his own group, have shown that maternal infections overall did not seem to be “specifically linked to mental disorders in the offspring.”
However, “specific maternal infections or specific brain-reactive antibodies during the pregnancy period have been shown to be associated with neurodevelopmental outcomes among the children,” such as intellectual disability, he said.
Regarding direct clinical implications of the study, “it is important to note that the increased risk of psychiatric disorders and suicidality in the offspring of mothers with PID were small,” Dr. Benros said.
“However, it adds an important part to the scientific puzzle regarding the role of maternal immune activation during pregnancy and the risk of mental disorders,” he added.
The study was funded by the Söderström König Foundation and the Fredrik and Ingrid Thuring Foundation. Neither Dr. Isung nor Dr. Benros reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
new research suggests.
Results from a cohort study of more than 4.2 million individuals showed that offspring of mothers with PIDs had a 17% increased risk for a psychiatric disorder and a 20% increased risk for suicidal behavior, compared with their peers with mothers who did not have PIDs.
The risk was more pronounced in offspring of mothers with both PIDs and autoimmune diseases. These risks remained after strictly controlling for different covariates, such as the parents’ psychiatric history, offspring PIDs, and offspring autoimmune diseases.
The investigators, led by Josef Isung, MD, PhD, Centre for Psychiatry Research, department of clinical neuroscience, Karolinska Institutet, Stockholm, noted that they could not “pinpoint a precise causal mechanism” underlying these findings.
Still, “the results add to the existing literature suggesting that the intrauterine immune environment may have implications for fetal neurodevelopment and that a compromised maternal immune system during pregnancy may be a risk factor for psychiatric disorders and suicidal behavior in their offspring in the long term,” they wrote.
The findings were published online in JAMA Psychiatry.
‘Natural experiment’
Maternal immune activation (MIA) is “an overarching term for aberrant and disrupted immune activity in the mother during gestation [and] has long been of interest in relation to adverse health outcomes in the offspring,” Dr. Isung noted.
“In relation to negative psychiatric outcomes, there is an abundance of preclinical evidence that has shown a negative impact on offspring secondary to MIA. And in humans, there are several observational studies supporting this link,” he said in an interview.
Dr. Isung added that PIDs are “rare conditions” known to be associated with repeated infections and high rates of autoimmune diseases, causing substantial disability.
“PIDs represent an interesting ‘natural experiment’ for researchers to understand more about the association between immune system dysfunctions and mental health,” he said.
Dr. Isung’s group previously showed that individuals with PIDs have increased odds of psychiatric disorders and suicidal behavior. The link was more pronounced in women with PIDs – and was even more pronounced in those with both PIDs and autoimmune diseases.
In the current study, “we wanted to see whether offspring of individuals were differentially at risk of psychiatric disorders and suicidal behavior, depending on being offspring of mothers or fathers with PIDs,” Dr. Isung said.
“Our hypothesis was that mothers with PIDs would have an increased risk of having offspring with neuropsychiatric outcomes, and that this risk could be due to MIA,” he added.
The researchers turned to Swedish nationwide health and administrative registers. They analyzed data on all individuals with diagnoses of PIDs identified between 1973 and 2013. Offspring born prior to 2003 were included, and parent-offspring pairs in which both parents had a history of PIDs were excluded.
The final study sample consisted of 4,294,169 offspring (51.4% boys). Of these participants, 7,270 (0.17%) had a parent with PIDs.
The researchers identified lifetime records of 10 psychiatric disorders: obsessive-compulsive disorder, ADHD, autism spectrum disorders, schizophrenia and other psychotic disorders, bipolar disorders, major depressive disorder and other mood disorders, anxiety and stress-related disorders, eating disorders, substance use disorders, and Tourette syndrome and chronic tic disorders.
The investigators included parental birth year, psychopathology, suicide attempts, suicide deaths, and autoimmune diseases as covariates, as well as offsprings’ birth year and gender.
Elucidation needed
Results showed that, of the 4,676 offspring of mothers with PID, 17.1% had a psychiatric disorder versus 12.7% of offspring of mothers without PIDs. This translated “into a 17% increased risk for offspring of mothers with PIDs in the fully adjusted model,” the investigators reported.
The risk was even higher for offspring of mothers who had not only PIDs but also one of six of the individual psychiatric disorders, with incident rate ratios ranging from 1.15 to 1.71.
“In fully adjusted models, offspring of mothers with PIDs had an increased risk of any psychiatric disorder, while no such risks were observed in offspring of fathers with PIDs” (IRR, 1.17 vs. 1.03; P < .001), the researchers reported.
A higher risk for suicidal behavior was also observed among offspring of mothers with PIDS, in contrast to those of fathers with PIDs (IRR, 1.2 vs. 1.1; P = .01).
The greatest risk for any psychiatric disorder, as well as suicidal behavior, was found in offspring of mothers who had both PIDs and autoimmune diseases (IRRs, 1.24 and 1.44, respectively).
“The results could be seen as substantiating the hypothesis that immune disruption may be important in the pathophysiology of psychiatric disorders and suicidal behavior,” Dr. Isung said.
“Furthermore, the fact that only offspring of mothers and not offspring of fathers with PIDs had this association would align with our hypothesis that MIA is of importance,” he added.
However, he noted that “the specific mechanisms are most likely multifactorial and remain to be elucidated.”
Important piece of the puzzle?
In a comment, Michael Eriksen Benros, MD, PhD, professor of immunopsychiatry, department of immunology and microbiology, health, and medical sciences, University of Copenhagen, said this was a “high-quality study” that used a “rich data source.”
Dr. Benros, who is also head of research (biological and precision psychiatry) at the Copenhagen Research Centre for Mental Health, Copenhagen University Hospital, was not involved with the current study.
He noted that prior studies, including some conducted by his own group, have shown that maternal infections overall did not seem to be “specifically linked to mental disorders in the offspring.”
However, “specific maternal infections or specific brain-reactive antibodies during the pregnancy period have been shown to be associated with neurodevelopmental outcomes among the children,” such as intellectual disability, he said.
Regarding direct clinical implications of the study, “it is important to note that the increased risk of psychiatric disorders and suicidality in the offspring of mothers with PID were small,” Dr. Benros said.
“However, it adds an important part to the scientific puzzle regarding the role of maternal immune activation during pregnancy and the risk of mental disorders,” he added.
The study was funded by the Söderström König Foundation and the Fredrik and Ingrid Thuring Foundation. Neither Dr. Isung nor Dr. Benros reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Obstetric violence: How it’s defined and how we face it
In a recent, tragic case, a newborn died from being crushed by its mother, who fell asleep from the fatigue of numerous hours of labor. The case has brought the issue of obstetric violence (OV) to the attention of the Italian media. OV is defined as neglect, physical abuse, or disrespect during childbirth, according to the World Health Organization. The WHO outlined fundamental actions to be taken at various levels for its prevention, especially by health care systems, in a 2014 position paper.
Gender-based abuse
Considered a form of gender-based abuse, OV was first described in Latin America in the early 2000s. It is widespread and is increasing in European countries.
From the scientific literature on the subject, OV seems to be strongly associated with a lack of communication between health care personnel and pregnant women. It appears to have more to do with authoritarian and paternalistic behavior than actual real-life medical issues. Actively involving women in decision-making regarding childbirth and postpartum care seems to reduce the incidence of OV. Pregnant women who are more involved appear to trust health care professionals more and are therefore less likely to report disrespectful and abusive behavior.
Estimates of the prevalence of OV vary, depending on the country, the childbirth facility, and its definition. In Italy, inspired by the web campaign “#Bastatacere: le madri hanno voce [#EnoughSilence: mothers have a voice],” in 2017, the Obstetric Violence Database (OVO) investigated perceptions of having been a victim of OV in a representative sample of Italian women aged 18-54 years who had at least one child.
In 2017, just over 20% of the women interviewed considered themselves victims of OV; 33% felt they had not received adequate care; and around 35% reported serious problems concerning privacy or trust. Following the treatment received, approximately 15% of the women decided not to return to the same health care facility, and 6% did not want to proceed with further pregnancies.
At the time of publication, the results sparked a debate among relevant medical associations (the Association of Obstetricians and Gynecologists of Italian Hospitals, the Italian Society of Gynecology and Obstetrics, and the Association of Italian University Gynecologists), which immediately recognized the importance of the topic and accepted an invitation for further discussion on physician-patient relationships. They expressed reservations concerning the methodologies used by the OVO for data collection, especially regarding the representativeness of the sample.
Lack of communication
“In general, women who claim to have suffered from obstetric violence do not do so because they have been denied an aspect of care but because they have had an overall experience that, for whatever reason, did not conform with their expectations,” said Irene Cetin, MD, PhD, professor of obstetrics and gynecology at the University of Milan and director of the obstetrics and gynecology unit of the Buzzi Hospital in Milan. “Following the OVO’s exposé, the Italian Society of Gynecology and Obstetrics also conducted a large-scale study throughout Italy on all women who had given birth within a 3-month period. That investigation painted a very different picture. It wasn’t the case that no instances of obstetric violence were found, but the results were more contained. This is a very delicate subject, given that every report that we receive in hospital is always valued and looked into in detail, and women come to speak to us about errors and things that were missed.”
She added, “Experience leads me to say that complaints about what happens in the delivery room are extremely rare. What we hear more of, but still not often, are problems experienced during days spent in hospital immediately after childbirth.” There are never enough resources, which is the reason behind most problems. “The real hardships are found in the wards,” continued Dr. Cetin, “where the midwife-to-bed ratio is one or two to 30, and therefore this is where it is more difficult to feel like you’re being listened to. With COVID-19, the situation has gotten even worse, even though in my hospital we have always guaranteed, not without struggle, the presence of the partner in the delivery room.”
Only relatively recently have women’s partners been allowed into the hospital. In addition, a number of services, such as having the right beds and giving the correct explanations and information on how to establish a relationship with the child, are now being offered. These steps are necessary to guarantee what is referred to as a “humanizing birth,” a process in which the woman is at the center of the experience and is the main protagonist of the birth.
Lack of resources
This trend also is observed at the systemic level, where there is a lack of organization and resources. Few staff members are in the ward, even fewer specialists are in the psychological field, and contact is almost nonexistent after discharge from many hospitals and in many regions across Italy. There are, however, some positive aspects and hope for the future. “Just think,” said Dr. Cetin, “of how degree courses in obstetrics have changed over time, with a large part of teaching and training now being centered around the emotional aspects of birth.” From the gynecologist’s side, “most of the problems have been inherited from the past,” said Dr. Cetin. “Let’s not forget that we have only recently been giving birth in hospital. The so-called medicalization of childbirth has been responsible for a decline in the death rate and morbidity rate of pregnant women, but initially, there was little interest or care in how women felt in this situation, including with regard to physical pain. Since the 1970s, with Leboyer from France and Miraglia from Italy [promoters of so-called sweet birth], a path was cleared for a different line of thought. For this reason, I believe that the situation will improve over time.
“To continuously improve physician-patient communication,” concluded Dr. Cetin, “it would perhaps be appropriate to make sure that, even in the preparatory phase, women are well aware of possible complications and of the necessary and rapid emergency procedures that must be implemented by health care personnel. This way, a trusting relationship could be maintained, and the perception of having suffered abuse due to not being involved in strictly medical decisions could be stemmed.”
This article was translated from Univadis Italy. A version of this article appeared on Medscape.com.
In a recent, tragic case, a newborn died from being crushed by its mother, who fell asleep from the fatigue of numerous hours of labor. The case has brought the issue of obstetric violence (OV) to the attention of the Italian media. OV is defined as neglect, physical abuse, or disrespect during childbirth, according to the World Health Organization. The WHO outlined fundamental actions to be taken at various levels for its prevention, especially by health care systems, in a 2014 position paper.
Gender-based abuse
Considered a form of gender-based abuse, OV was first described in Latin America in the early 2000s. It is widespread and is increasing in European countries.
From the scientific literature on the subject, OV seems to be strongly associated with a lack of communication between health care personnel and pregnant women. It appears to have more to do with authoritarian and paternalistic behavior than actual real-life medical issues. Actively involving women in decision-making regarding childbirth and postpartum care seems to reduce the incidence of OV. Pregnant women who are more involved appear to trust health care professionals more and are therefore less likely to report disrespectful and abusive behavior.
Estimates of the prevalence of OV vary, depending on the country, the childbirth facility, and its definition. In Italy, inspired by the web campaign “#Bastatacere: le madri hanno voce [#EnoughSilence: mothers have a voice],” in 2017, the Obstetric Violence Database (OVO) investigated perceptions of having been a victim of OV in a representative sample of Italian women aged 18-54 years who had at least one child.
In 2017, just over 20% of the women interviewed considered themselves victims of OV; 33% felt they had not received adequate care; and around 35% reported serious problems concerning privacy or trust. Following the treatment received, approximately 15% of the women decided not to return to the same health care facility, and 6% did not want to proceed with further pregnancies.
At the time of publication, the results sparked a debate among relevant medical associations (the Association of Obstetricians and Gynecologists of Italian Hospitals, the Italian Society of Gynecology and Obstetrics, and the Association of Italian University Gynecologists), which immediately recognized the importance of the topic and accepted an invitation for further discussion on physician-patient relationships. They expressed reservations concerning the methodologies used by the OVO for data collection, especially regarding the representativeness of the sample.
Lack of communication
“In general, women who claim to have suffered from obstetric violence do not do so because they have been denied an aspect of care but because they have had an overall experience that, for whatever reason, did not conform with their expectations,” said Irene Cetin, MD, PhD, professor of obstetrics and gynecology at the University of Milan and director of the obstetrics and gynecology unit of the Buzzi Hospital in Milan. “Following the OVO’s exposé, the Italian Society of Gynecology and Obstetrics also conducted a large-scale study throughout Italy on all women who had given birth within a 3-month period. That investigation painted a very different picture. It wasn’t the case that no instances of obstetric violence were found, but the results were more contained. This is a very delicate subject, given that every report that we receive in hospital is always valued and looked into in detail, and women come to speak to us about errors and things that were missed.”
She added, “Experience leads me to say that complaints about what happens in the delivery room are extremely rare. What we hear more of, but still not often, are problems experienced during days spent in hospital immediately after childbirth.” There are never enough resources, which is the reason behind most problems. “The real hardships are found in the wards,” continued Dr. Cetin, “where the midwife-to-bed ratio is one or two to 30, and therefore this is where it is more difficult to feel like you’re being listened to. With COVID-19, the situation has gotten even worse, even though in my hospital we have always guaranteed, not without struggle, the presence of the partner in the delivery room.”
Only relatively recently have women’s partners been allowed into the hospital. In addition, a number of services, such as having the right beds and giving the correct explanations and information on how to establish a relationship with the child, are now being offered. These steps are necessary to guarantee what is referred to as a “humanizing birth,” a process in which the woman is at the center of the experience and is the main protagonist of the birth.
Lack of resources
This trend also is observed at the systemic level, where there is a lack of organization and resources. Few staff members are in the ward, even fewer specialists are in the psychological field, and contact is almost nonexistent after discharge from many hospitals and in many regions across Italy. There are, however, some positive aspects and hope for the future. “Just think,” said Dr. Cetin, “of how degree courses in obstetrics have changed over time, with a large part of teaching and training now being centered around the emotional aspects of birth.” From the gynecologist’s side, “most of the problems have been inherited from the past,” said Dr. Cetin. “Let’s not forget that we have only recently been giving birth in hospital. The so-called medicalization of childbirth has been responsible for a decline in the death rate and morbidity rate of pregnant women, but initially, there was little interest or care in how women felt in this situation, including with regard to physical pain. Since the 1970s, with Leboyer from France and Miraglia from Italy [promoters of so-called sweet birth], a path was cleared for a different line of thought. For this reason, I believe that the situation will improve over time.
“To continuously improve physician-patient communication,” concluded Dr. Cetin, “it would perhaps be appropriate to make sure that, even in the preparatory phase, women are well aware of possible complications and of the necessary and rapid emergency procedures that must be implemented by health care personnel. This way, a trusting relationship could be maintained, and the perception of having suffered abuse due to not being involved in strictly medical decisions could be stemmed.”
This article was translated from Univadis Italy. A version of this article appeared on Medscape.com.
In a recent, tragic case, a newborn died from being crushed by its mother, who fell asleep from the fatigue of numerous hours of labor. The case has brought the issue of obstetric violence (OV) to the attention of the Italian media. OV is defined as neglect, physical abuse, or disrespect during childbirth, according to the World Health Organization. The WHO outlined fundamental actions to be taken at various levels for its prevention, especially by health care systems, in a 2014 position paper.
Gender-based abuse
Considered a form of gender-based abuse, OV was first described in Latin America in the early 2000s. It is widespread and is increasing in European countries.
From the scientific literature on the subject, OV seems to be strongly associated with a lack of communication between health care personnel and pregnant women. It appears to have more to do with authoritarian and paternalistic behavior than actual real-life medical issues. Actively involving women in decision-making regarding childbirth and postpartum care seems to reduce the incidence of OV. Pregnant women who are more involved appear to trust health care professionals more and are therefore less likely to report disrespectful and abusive behavior.
Estimates of the prevalence of OV vary, depending on the country, the childbirth facility, and its definition. In Italy, inspired by the web campaign “#Bastatacere: le madri hanno voce [#EnoughSilence: mothers have a voice],” in 2017, the Obstetric Violence Database (OVO) investigated perceptions of having been a victim of OV in a representative sample of Italian women aged 18-54 years who had at least one child.
In 2017, just over 20% of the women interviewed considered themselves victims of OV; 33% felt they had not received adequate care; and around 35% reported serious problems concerning privacy or trust. Following the treatment received, approximately 15% of the women decided not to return to the same health care facility, and 6% did not want to proceed with further pregnancies.
At the time of publication, the results sparked a debate among relevant medical associations (the Association of Obstetricians and Gynecologists of Italian Hospitals, the Italian Society of Gynecology and Obstetrics, and the Association of Italian University Gynecologists), which immediately recognized the importance of the topic and accepted an invitation for further discussion on physician-patient relationships. They expressed reservations concerning the methodologies used by the OVO for data collection, especially regarding the representativeness of the sample.
Lack of communication
“In general, women who claim to have suffered from obstetric violence do not do so because they have been denied an aspect of care but because they have had an overall experience that, for whatever reason, did not conform with their expectations,” said Irene Cetin, MD, PhD, professor of obstetrics and gynecology at the University of Milan and director of the obstetrics and gynecology unit of the Buzzi Hospital in Milan. “Following the OVO’s exposé, the Italian Society of Gynecology and Obstetrics also conducted a large-scale study throughout Italy on all women who had given birth within a 3-month period. That investigation painted a very different picture. It wasn’t the case that no instances of obstetric violence were found, but the results were more contained. This is a very delicate subject, given that every report that we receive in hospital is always valued and looked into in detail, and women come to speak to us about errors and things that were missed.”
She added, “Experience leads me to say that complaints about what happens in the delivery room are extremely rare. What we hear more of, but still not often, are problems experienced during days spent in hospital immediately after childbirth.” There are never enough resources, which is the reason behind most problems. “The real hardships are found in the wards,” continued Dr. Cetin, “where the midwife-to-bed ratio is one or two to 30, and therefore this is where it is more difficult to feel like you’re being listened to. With COVID-19, the situation has gotten even worse, even though in my hospital we have always guaranteed, not without struggle, the presence of the partner in the delivery room.”
Only relatively recently have women’s partners been allowed into the hospital. In addition, a number of services, such as having the right beds and giving the correct explanations and information on how to establish a relationship with the child, are now being offered. These steps are necessary to guarantee what is referred to as a “humanizing birth,” a process in which the woman is at the center of the experience and is the main protagonist of the birth.
Lack of resources
This trend also is observed at the systemic level, where there is a lack of organization and resources. Few staff members are in the ward, even fewer specialists are in the psychological field, and contact is almost nonexistent after discharge from many hospitals and in many regions across Italy. There are, however, some positive aspects and hope for the future. “Just think,” said Dr. Cetin, “of how degree courses in obstetrics have changed over time, with a large part of teaching and training now being centered around the emotional aspects of birth.” From the gynecologist’s side, “most of the problems have been inherited from the past,” said Dr. Cetin. “Let’s not forget that we have only recently been giving birth in hospital. The so-called medicalization of childbirth has been responsible for a decline in the death rate and morbidity rate of pregnant women, but initially, there was little interest or care in how women felt in this situation, including with regard to physical pain. Since the 1970s, with Leboyer from France and Miraglia from Italy [promoters of so-called sweet birth], a path was cleared for a different line of thought. For this reason, I believe that the situation will improve over time.
“To continuously improve physician-patient communication,” concluded Dr. Cetin, “it would perhaps be appropriate to make sure that, even in the preparatory phase, women are well aware of possible complications and of the necessary and rapid emergency procedures that must be implemented by health care personnel. This way, a trusting relationship could be maintained, and the perception of having suffered abuse due to not being involved in strictly medical decisions could be stemmed.”
This article was translated from Univadis Italy. A version of this article appeared on Medscape.com.
Doctors are disappearing from emergency departments as hospitals look to cut costs
She didn’t know much about miscarriage, but this seemed like one.
In the emergency department, she was examined then sent home, she said. She went back when her cramping became excruciating. Then home again. It ultimately took three trips to the ED on 3 consecutive days, generating three separate bills, before she saw a doctor who looked at her blood work and confirmed her fears.
“At the time I wasn’t thinking, ‘Oh, I need to see a doctor,’ ” Ms. Valle recalled. “But when you think about it, it’s like, ‘Well, dang – why didn’t I see a doctor?’ ” It’s unclear whether the repeat visits were due to delays in seeing a physician, but the experience worried her. And she’s still paying the bills.
The hospital declined to discuss Ms. Valle’s care, citing patient privacy. But 17 months before her 3-day ordeal, Tennova had outsourced its emergency departments to American Physician Partners, a medical staffing company owned by private equity investors. APP employs fewer doctors in its EDs as one of its cost-saving initiatives to increase earnings, according to a confidential company document obtained by KHN and NPR.
This staffing strategy has permeated hospitals, and particularly emergency departments, that seek to reduce their top expense: physician labor. While diagnosing and treating patients was once their domain, doctors are increasingly being replaced by nurse practitioners and physician assistants, collectively known as “midlevel practitioners,” who can perform many of the same duties and generate much of the same revenue for less than half of the pay.
“APP has numerous cost saving initiatives underway as part of the Company’s continual focus on cost optimization,” the document says, including a “shift of staffing” between doctors and midlevel practitioners.
In a statement to KHN, American Physician Partners said this strategy is a way to ensure all EDs remain fully staffed, calling it a “blended model” that allows doctors, nurse practitioners, and physician assistants “to provide care to their fullest potential.”
Critics of this strategy say the quest to save money results in treatment meted out by someone with far less training than a physician, leaving patients vulnerable to misdiagnoses, higher medical bills, and inadequate care. And these fears are bolstered by evidence that suggests dropping doctors from EDs may not be good for patients.
A working paper, published in October by the National Bureau of Economic Research, analyzed roughly 1.1 million visits to 44 EDs throughout the Veterans Health Administration, where nurse practitioners can treat patients without oversight from doctors.
Researchers found that treatment by a nurse practitioner resulted on average in a 7% increase in cost of care and an 11% increase in length of stay, extending patients’ time in the ED by minutes for minor visits and hours for longer ones. These gaps widened among patients with more severe diagnoses, the study said, but could be somewhat mitigated by nurse practitioners with more experience.
The study also found that ED patients treated by a nurse practitioner were 20% more likely to be readmitted to the hospital for a preventable reason within 30 days, although the overall risk of readmission remained very small.
Yiqun Chen, PhD, who is an assistant professor of economics at the University of Illinois at Chicago and coauthored the study, said these findings are not an indictment of nurse practitioners in the ED. Instead, she said, she hopes the study will guide how to best deploy nurse practitioners: in treatment of simpler patients or circumstances when no doctor is available.
“It’s not just a simple question of if we can substitute physicians with nurse practitioners or not,” Dr. Chen said. “It depends on how we use them. If we just use them as independent providers, especially ... for relatively complicated patients, it doesn’t seem to be a very good use.”
Dr. Chen’s research echoes smaller studies, like one from The Harvey L. Neiman Health Policy Institute that found nonphysician practitioners in EDs were associated with a 5.3% increase in imaging, which could unnecessarily increase bills for patients. Separately, a study at the Hattiesburg Clinic in Mississippi found that midlevel practitioners in primary care – not in the emergency department – increased the out-of-pocket costs to patients while also leading to worse performance on 9 of 10 quality-of-care metrics, including cancer screenings and vaccination rates.
But definitive evidence remains elusive that replacing ER doctors with nonphysicians has a negative impact on patients, said Cameron Gettel, MD, an assistant professor of emergency medicine at Yale University, New Haven, Conn. Private equity investment and the use of midlevel practitioners rose in lockstep in the ED, Dr. Gettel said, and in the absence of game-changing research, the pattern will likely continue.
“Worse patient outcomes haven’t really been shown across the board,” he said. “And I think until that is shown, then they will continue to play an increasing role.”
For private equity, dropping ED docs is a “simple equation”
Private equity companies pool money from wealthy investors to buy their way into various industries, often slashing spending and seeking to flip businesses in 3 to 7 years. While this business model is a proven moneymaker on Wall Street, it raises concerns in health care, where critics worry the pressure to turn big profits will influence life-or-death decisions that were once left solely to medical professionals.
Nearly $1 trillion in private equity funds have gone into almost 8,000 health care transactions over the past decade, according to industry tracker PitchBook, including buying into medical staffing companies that many hospitals hire to manage their emergency departments.
Two firms dominate the ED staffing industry: TeamHealth, bought by private equity firm Blackstone in 2016, and Envision Healthcare, bought by KKR in 2018. Trying to undercut these staffing giants is American Physician Partners, a rapidly expanding company that runs EDs in at least 17 states and is 50% owned by private equity firm BBH Capital Partners.
These staffing companies have been among the most aggressive in replacing doctors to cut costs, said Robert McNamara, MD, a founder of the American Academy of Emergency Medicine and chair of emergency medicine at Temple University, Philadelphia.
“It’s a relatively simple equation,” Dr. McNamara said. “Their No. 1 expense is the board-certified emergency physician. So they are going to want to keep that expense as low as possible.”
Not everyone sees the trend of private equity in ED staffing in a negative light. Jennifer Orozco, president of the American Academy of Physician Associates, which represents physician assistants, said even if the change – to use more nonphysician providers – is driven by the staffing firms’ desire to make more money, patients are still well served by a team approach that includes nurse practitioners and physician assistants.
“Though I see that shift, it’s not about profits at the end of the day,” Ms. Orozco said. “It’s about the patient.”
The “shift” is nearly invisible to patients because hospitals rarely promote branding from their ED staffing firms and there is little public documentation of private equity investments.
Arthur Smolensky, MD, a Tennessee emergency medicine specialist attempting to measure private equity’s intrusion into EDs, said his review of hospital job postings and employment contracts in 14 major metropolitan areas found that 43% of ED patients were seen in EDs staffed by companies with nonphysician owners, nearly all of whom are private equity investors.
Dr. Smolensky hopes to publish his full study, expanding to 55 metro areas, later this year. But this research will merely quantify what many doctors already know: The ED has changed. Demoralized by an increased focus on profit, and wary of a looming surplus of emergency medicine residents because there are fewer jobs to fill, many experienced doctors are leaving the ED on their own, he said.
“Most of us didn’t go into medicine to supervise an army of people that are not as well trained as we are,” Dr. Smolensky said. “We want to take care of patients.”
“I guess we’re the first guinea pigs for our ER”
Joshua Allen, a nurse practitioner at a small Kentucky hospital, snaked a rubber hose through a rack of pork ribs to practice inserting a chest tube to fix a collapsed lung.
It was 2020, and American Physician Partners was restructuring the ED where Mr. Allen worked, reducing shifts from two doctors to one. Once Mr. Allen had placed 10 tubes under a doctor’s supervision, he would be allowed to do it on his own.
“I guess we’re the first guinea pigs for our ER,” he said. “If we do have a major trauma and multiple victims come in, there’s only one doctor there. ... We need to be prepared.”
Mr. Allen is one of many midlevel practitioners finding work in emergency departments. Nurse practitioners and physician assistants are among the fastest-growing occupations in the nation, according to the U.S. Bureau of Labor Statistics.
Generally, they have master’s degrees and receive several years of specialized schooling but have significantly less training than doctors. Many are permitted to diagnose patients and prescribe medication with little or no supervision from a doctor, although limitations vary by state.
The Neiman Institute found that the share of ED visits in which a midlevel practitioner was the main clinician increased by more than 172% between 2005 and 2020. Another study, in the Journal of Emergency Medicine, reported that if trends continue there may be equal numbers of midlevel practitioners and doctors in EDs by 2030.
There is little mystery as to why. Federal data shows emergency medicine doctors are paid about $310,000 a year on average, while nurse practitioners and physician assistants earn less than $120,000. Generally, hospitals can bill for care by a midlevel practitioner at 85% the rate of a doctor while paying them less than half as much.
Private equity can make millions in the gap.
For example, Envision once encouraged EDs to employ “the least expensive resource” and treat up to 35% of patients with midlevel practitioners, according to a 2017 PowerPoint presentation. The presentation drew scorn on social media and disappeared from Envision’s website.
Envision declined a request for a phone interview. In a written statement to KHN, spokesperson Aliese Polk said the company does not direct its physician leaders on how to care for patients and called the presentation a “concept guide” that does not represent current views.
American Physician Partners touted roughly the same staffing strategy in 2021 in response to the No Surprises Act, which threatened the company’s profits by outlawing surprise medical bills. In its confidential pitch to lenders, the company estimated it could cut almost $6 million by shifting more staffing from physicians to midlevel practitioners.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
She didn’t know much about miscarriage, but this seemed like one.
In the emergency department, she was examined then sent home, she said. She went back when her cramping became excruciating. Then home again. It ultimately took three trips to the ED on 3 consecutive days, generating three separate bills, before she saw a doctor who looked at her blood work and confirmed her fears.
“At the time I wasn’t thinking, ‘Oh, I need to see a doctor,’ ” Ms. Valle recalled. “But when you think about it, it’s like, ‘Well, dang – why didn’t I see a doctor?’ ” It’s unclear whether the repeat visits were due to delays in seeing a physician, but the experience worried her. And she’s still paying the bills.
The hospital declined to discuss Ms. Valle’s care, citing patient privacy. But 17 months before her 3-day ordeal, Tennova had outsourced its emergency departments to American Physician Partners, a medical staffing company owned by private equity investors. APP employs fewer doctors in its EDs as one of its cost-saving initiatives to increase earnings, according to a confidential company document obtained by KHN and NPR.
This staffing strategy has permeated hospitals, and particularly emergency departments, that seek to reduce their top expense: physician labor. While diagnosing and treating patients was once their domain, doctors are increasingly being replaced by nurse practitioners and physician assistants, collectively known as “midlevel practitioners,” who can perform many of the same duties and generate much of the same revenue for less than half of the pay.
“APP has numerous cost saving initiatives underway as part of the Company’s continual focus on cost optimization,” the document says, including a “shift of staffing” between doctors and midlevel practitioners.
In a statement to KHN, American Physician Partners said this strategy is a way to ensure all EDs remain fully staffed, calling it a “blended model” that allows doctors, nurse practitioners, and physician assistants “to provide care to their fullest potential.”
Critics of this strategy say the quest to save money results in treatment meted out by someone with far less training than a physician, leaving patients vulnerable to misdiagnoses, higher medical bills, and inadequate care. And these fears are bolstered by evidence that suggests dropping doctors from EDs may not be good for patients.
A working paper, published in October by the National Bureau of Economic Research, analyzed roughly 1.1 million visits to 44 EDs throughout the Veterans Health Administration, where nurse practitioners can treat patients without oversight from doctors.
Researchers found that treatment by a nurse practitioner resulted on average in a 7% increase in cost of care and an 11% increase in length of stay, extending patients’ time in the ED by minutes for minor visits and hours for longer ones. These gaps widened among patients with more severe diagnoses, the study said, but could be somewhat mitigated by nurse practitioners with more experience.
The study also found that ED patients treated by a nurse practitioner were 20% more likely to be readmitted to the hospital for a preventable reason within 30 days, although the overall risk of readmission remained very small.
Yiqun Chen, PhD, who is an assistant professor of economics at the University of Illinois at Chicago and coauthored the study, said these findings are not an indictment of nurse practitioners in the ED. Instead, she said, she hopes the study will guide how to best deploy nurse practitioners: in treatment of simpler patients or circumstances when no doctor is available.
“It’s not just a simple question of if we can substitute physicians with nurse practitioners or not,” Dr. Chen said. “It depends on how we use them. If we just use them as independent providers, especially ... for relatively complicated patients, it doesn’t seem to be a very good use.”
Dr. Chen’s research echoes smaller studies, like one from The Harvey L. Neiman Health Policy Institute that found nonphysician practitioners in EDs were associated with a 5.3% increase in imaging, which could unnecessarily increase bills for patients. Separately, a study at the Hattiesburg Clinic in Mississippi found that midlevel practitioners in primary care – not in the emergency department – increased the out-of-pocket costs to patients while also leading to worse performance on 9 of 10 quality-of-care metrics, including cancer screenings and vaccination rates.
But definitive evidence remains elusive that replacing ER doctors with nonphysicians has a negative impact on patients, said Cameron Gettel, MD, an assistant professor of emergency medicine at Yale University, New Haven, Conn. Private equity investment and the use of midlevel practitioners rose in lockstep in the ED, Dr. Gettel said, and in the absence of game-changing research, the pattern will likely continue.
“Worse patient outcomes haven’t really been shown across the board,” he said. “And I think until that is shown, then they will continue to play an increasing role.”
For private equity, dropping ED docs is a “simple equation”
Private equity companies pool money from wealthy investors to buy their way into various industries, often slashing spending and seeking to flip businesses in 3 to 7 years. While this business model is a proven moneymaker on Wall Street, it raises concerns in health care, where critics worry the pressure to turn big profits will influence life-or-death decisions that were once left solely to medical professionals.
Nearly $1 trillion in private equity funds have gone into almost 8,000 health care transactions over the past decade, according to industry tracker PitchBook, including buying into medical staffing companies that many hospitals hire to manage their emergency departments.
Two firms dominate the ED staffing industry: TeamHealth, bought by private equity firm Blackstone in 2016, and Envision Healthcare, bought by KKR in 2018. Trying to undercut these staffing giants is American Physician Partners, a rapidly expanding company that runs EDs in at least 17 states and is 50% owned by private equity firm BBH Capital Partners.
These staffing companies have been among the most aggressive in replacing doctors to cut costs, said Robert McNamara, MD, a founder of the American Academy of Emergency Medicine and chair of emergency medicine at Temple University, Philadelphia.
“It’s a relatively simple equation,” Dr. McNamara said. “Their No. 1 expense is the board-certified emergency physician. So they are going to want to keep that expense as low as possible.”
Not everyone sees the trend of private equity in ED staffing in a negative light. Jennifer Orozco, president of the American Academy of Physician Associates, which represents physician assistants, said even if the change – to use more nonphysician providers – is driven by the staffing firms’ desire to make more money, patients are still well served by a team approach that includes nurse practitioners and physician assistants.
“Though I see that shift, it’s not about profits at the end of the day,” Ms. Orozco said. “It’s about the patient.”
The “shift” is nearly invisible to patients because hospitals rarely promote branding from their ED staffing firms and there is little public documentation of private equity investments.
Arthur Smolensky, MD, a Tennessee emergency medicine specialist attempting to measure private equity’s intrusion into EDs, said his review of hospital job postings and employment contracts in 14 major metropolitan areas found that 43% of ED patients were seen in EDs staffed by companies with nonphysician owners, nearly all of whom are private equity investors.
Dr. Smolensky hopes to publish his full study, expanding to 55 metro areas, later this year. But this research will merely quantify what many doctors already know: The ED has changed. Demoralized by an increased focus on profit, and wary of a looming surplus of emergency medicine residents because there are fewer jobs to fill, many experienced doctors are leaving the ED on their own, he said.
“Most of us didn’t go into medicine to supervise an army of people that are not as well trained as we are,” Dr. Smolensky said. “We want to take care of patients.”
“I guess we’re the first guinea pigs for our ER”
Joshua Allen, a nurse practitioner at a small Kentucky hospital, snaked a rubber hose through a rack of pork ribs to practice inserting a chest tube to fix a collapsed lung.
It was 2020, and American Physician Partners was restructuring the ED where Mr. Allen worked, reducing shifts from two doctors to one. Once Mr. Allen had placed 10 tubes under a doctor’s supervision, he would be allowed to do it on his own.
“I guess we’re the first guinea pigs for our ER,” he said. “If we do have a major trauma and multiple victims come in, there’s only one doctor there. ... We need to be prepared.”
Mr. Allen is one of many midlevel practitioners finding work in emergency departments. Nurse practitioners and physician assistants are among the fastest-growing occupations in the nation, according to the U.S. Bureau of Labor Statistics.
Generally, they have master’s degrees and receive several years of specialized schooling but have significantly less training than doctors. Many are permitted to diagnose patients and prescribe medication with little or no supervision from a doctor, although limitations vary by state.
The Neiman Institute found that the share of ED visits in which a midlevel practitioner was the main clinician increased by more than 172% between 2005 and 2020. Another study, in the Journal of Emergency Medicine, reported that if trends continue there may be equal numbers of midlevel practitioners and doctors in EDs by 2030.
There is little mystery as to why. Federal data shows emergency medicine doctors are paid about $310,000 a year on average, while nurse practitioners and physician assistants earn less than $120,000. Generally, hospitals can bill for care by a midlevel practitioner at 85% the rate of a doctor while paying them less than half as much.
Private equity can make millions in the gap.
For example, Envision once encouraged EDs to employ “the least expensive resource” and treat up to 35% of patients with midlevel practitioners, according to a 2017 PowerPoint presentation. The presentation drew scorn on social media and disappeared from Envision’s website.
Envision declined a request for a phone interview. In a written statement to KHN, spokesperson Aliese Polk said the company does not direct its physician leaders on how to care for patients and called the presentation a “concept guide” that does not represent current views.
American Physician Partners touted roughly the same staffing strategy in 2021 in response to the No Surprises Act, which threatened the company’s profits by outlawing surprise medical bills. In its confidential pitch to lenders, the company estimated it could cut almost $6 million by shifting more staffing from physicians to midlevel practitioners.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
She didn’t know much about miscarriage, but this seemed like one.
In the emergency department, she was examined then sent home, she said. She went back when her cramping became excruciating. Then home again. It ultimately took three trips to the ED on 3 consecutive days, generating three separate bills, before she saw a doctor who looked at her blood work and confirmed her fears.
“At the time I wasn’t thinking, ‘Oh, I need to see a doctor,’ ” Ms. Valle recalled. “But when you think about it, it’s like, ‘Well, dang – why didn’t I see a doctor?’ ” It’s unclear whether the repeat visits were due to delays in seeing a physician, but the experience worried her. And she’s still paying the bills.
The hospital declined to discuss Ms. Valle’s care, citing patient privacy. But 17 months before her 3-day ordeal, Tennova had outsourced its emergency departments to American Physician Partners, a medical staffing company owned by private equity investors. APP employs fewer doctors in its EDs as one of its cost-saving initiatives to increase earnings, according to a confidential company document obtained by KHN and NPR.
This staffing strategy has permeated hospitals, and particularly emergency departments, that seek to reduce their top expense: physician labor. While diagnosing and treating patients was once their domain, doctors are increasingly being replaced by nurse practitioners and physician assistants, collectively known as “midlevel practitioners,” who can perform many of the same duties and generate much of the same revenue for less than half of the pay.
“APP has numerous cost saving initiatives underway as part of the Company’s continual focus on cost optimization,” the document says, including a “shift of staffing” between doctors and midlevel practitioners.
In a statement to KHN, American Physician Partners said this strategy is a way to ensure all EDs remain fully staffed, calling it a “blended model” that allows doctors, nurse practitioners, and physician assistants “to provide care to their fullest potential.”
Critics of this strategy say the quest to save money results in treatment meted out by someone with far less training than a physician, leaving patients vulnerable to misdiagnoses, higher medical bills, and inadequate care. And these fears are bolstered by evidence that suggests dropping doctors from EDs may not be good for patients.
A working paper, published in October by the National Bureau of Economic Research, analyzed roughly 1.1 million visits to 44 EDs throughout the Veterans Health Administration, where nurse practitioners can treat patients without oversight from doctors.
Researchers found that treatment by a nurse practitioner resulted on average in a 7% increase in cost of care and an 11% increase in length of stay, extending patients’ time in the ED by minutes for minor visits and hours for longer ones. These gaps widened among patients with more severe diagnoses, the study said, but could be somewhat mitigated by nurse practitioners with more experience.
The study also found that ED patients treated by a nurse practitioner were 20% more likely to be readmitted to the hospital for a preventable reason within 30 days, although the overall risk of readmission remained very small.
Yiqun Chen, PhD, who is an assistant professor of economics at the University of Illinois at Chicago and coauthored the study, said these findings are not an indictment of nurse practitioners in the ED. Instead, she said, she hopes the study will guide how to best deploy nurse practitioners: in treatment of simpler patients or circumstances when no doctor is available.
“It’s not just a simple question of if we can substitute physicians with nurse practitioners or not,” Dr. Chen said. “It depends on how we use them. If we just use them as independent providers, especially ... for relatively complicated patients, it doesn’t seem to be a very good use.”
Dr. Chen’s research echoes smaller studies, like one from The Harvey L. Neiman Health Policy Institute that found nonphysician practitioners in EDs were associated with a 5.3% increase in imaging, which could unnecessarily increase bills for patients. Separately, a study at the Hattiesburg Clinic in Mississippi found that midlevel practitioners in primary care – not in the emergency department – increased the out-of-pocket costs to patients while also leading to worse performance on 9 of 10 quality-of-care metrics, including cancer screenings and vaccination rates.
But definitive evidence remains elusive that replacing ER doctors with nonphysicians has a negative impact on patients, said Cameron Gettel, MD, an assistant professor of emergency medicine at Yale University, New Haven, Conn. Private equity investment and the use of midlevel practitioners rose in lockstep in the ED, Dr. Gettel said, and in the absence of game-changing research, the pattern will likely continue.
“Worse patient outcomes haven’t really been shown across the board,” he said. “And I think until that is shown, then they will continue to play an increasing role.”
For private equity, dropping ED docs is a “simple equation”
Private equity companies pool money from wealthy investors to buy their way into various industries, often slashing spending and seeking to flip businesses in 3 to 7 years. While this business model is a proven moneymaker on Wall Street, it raises concerns in health care, where critics worry the pressure to turn big profits will influence life-or-death decisions that were once left solely to medical professionals.
Nearly $1 trillion in private equity funds have gone into almost 8,000 health care transactions over the past decade, according to industry tracker PitchBook, including buying into medical staffing companies that many hospitals hire to manage their emergency departments.
Two firms dominate the ED staffing industry: TeamHealth, bought by private equity firm Blackstone in 2016, and Envision Healthcare, bought by KKR in 2018. Trying to undercut these staffing giants is American Physician Partners, a rapidly expanding company that runs EDs in at least 17 states and is 50% owned by private equity firm BBH Capital Partners.
These staffing companies have been among the most aggressive in replacing doctors to cut costs, said Robert McNamara, MD, a founder of the American Academy of Emergency Medicine and chair of emergency medicine at Temple University, Philadelphia.
“It’s a relatively simple equation,” Dr. McNamara said. “Their No. 1 expense is the board-certified emergency physician. So they are going to want to keep that expense as low as possible.”
Not everyone sees the trend of private equity in ED staffing in a negative light. Jennifer Orozco, president of the American Academy of Physician Associates, which represents physician assistants, said even if the change – to use more nonphysician providers – is driven by the staffing firms’ desire to make more money, patients are still well served by a team approach that includes nurse practitioners and physician assistants.
“Though I see that shift, it’s not about profits at the end of the day,” Ms. Orozco said. “It’s about the patient.”
The “shift” is nearly invisible to patients because hospitals rarely promote branding from their ED staffing firms and there is little public documentation of private equity investments.
Arthur Smolensky, MD, a Tennessee emergency medicine specialist attempting to measure private equity’s intrusion into EDs, said his review of hospital job postings and employment contracts in 14 major metropolitan areas found that 43% of ED patients were seen in EDs staffed by companies with nonphysician owners, nearly all of whom are private equity investors.
Dr. Smolensky hopes to publish his full study, expanding to 55 metro areas, later this year. But this research will merely quantify what many doctors already know: The ED has changed. Demoralized by an increased focus on profit, and wary of a looming surplus of emergency medicine residents because there are fewer jobs to fill, many experienced doctors are leaving the ED on their own, he said.
“Most of us didn’t go into medicine to supervise an army of people that are not as well trained as we are,” Dr. Smolensky said. “We want to take care of patients.”
“I guess we’re the first guinea pigs for our ER”
Joshua Allen, a nurse practitioner at a small Kentucky hospital, snaked a rubber hose through a rack of pork ribs to practice inserting a chest tube to fix a collapsed lung.
It was 2020, and American Physician Partners was restructuring the ED where Mr. Allen worked, reducing shifts from two doctors to one. Once Mr. Allen had placed 10 tubes under a doctor’s supervision, he would be allowed to do it on his own.
“I guess we’re the first guinea pigs for our ER,” he said. “If we do have a major trauma and multiple victims come in, there’s only one doctor there. ... We need to be prepared.”
Mr. Allen is one of many midlevel practitioners finding work in emergency departments. Nurse practitioners and physician assistants are among the fastest-growing occupations in the nation, according to the U.S. Bureau of Labor Statistics.
Generally, they have master’s degrees and receive several years of specialized schooling but have significantly less training than doctors. Many are permitted to diagnose patients and prescribe medication with little or no supervision from a doctor, although limitations vary by state.
The Neiman Institute found that the share of ED visits in which a midlevel practitioner was the main clinician increased by more than 172% between 2005 and 2020. Another study, in the Journal of Emergency Medicine, reported that if trends continue there may be equal numbers of midlevel practitioners and doctors in EDs by 2030.
There is little mystery as to why. Federal data shows emergency medicine doctors are paid about $310,000 a year on average, while nurse practitioners and physician assistants earn less than $120,000. Generally, hospitals can bill for care by a midlevel practitioner at 85% the rate of a doctor while paying them less than half as much.
Private equity can make millions in the gap.
For example, Envision once encouraged EDs to employ “the least expensive resource” and treat up to 35% of patients with midlevel practitioners, according to a 2017 PowerPoint presentation. The presentation drew scorn on social media and disappeared from Envision’s website.
Envision declined a request for a phone interview. In a written statement to KHN, spokesperson Aliese Polk said the company does not direct its physician leaders on how to care for patients and called the presentation a “concept guide” that does not represent current views.
American Physician Partners touted roughly the same staffing strategy in 2021 in response to the No Surprises Act, which threatened the company’s profits by outlawing surprise medical bills. In its confidential pitch to lenders, the company estimated it could cut almost $6 million by shifting more staffing from physicians to midlevel practitioners.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Antenatal corticosteroids: Fresh answers to old questions
Giving corticosteroids to pregnant women at risk for preterm birth before 34 weeks of gestational age has been the standard of care since the 1990s, but a few scenarios for their use remain up for debate. Two studies presented this week at the 2023 meeting sponsored by the Society for Maternal–Fetal Medicine provided some fresh insight into the practice that could help clinicians better manage pregnant patients.
Neurodevelopmental outcomes in late preterm
First, should antenatal corticosteroids (ACS) be given to mothers who present with late preterm labor, defined as 34-36 weeks’ gestational age?
A landmark randomized clinical trial published in 2016 demonstrated that use of ACS in mothers in late preterm labor reduced severe respiratory complications. That practice has largely been adopted by clinicians. The only downside, according to the researchers, was that infants whose mothers received steroid therapy were more likely to develop hypoglycemia. The condition is self-limiting, but studies have raised concern about the potential long-term risk of neurocognitive or psychological outcomes in infants with hypoglycemia.
Cynthia Gyamfi-Bannerman, MD, MSc, endowed chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, led the 2016 study. Her team was unable to secure funding for their originally planned follow-up study of the infants 2 years later. But once the American College of Obstetricians and Gynecologists endorsed the practice and more women received ACS in the late preterm period, Dr. Gyamfi-Bannerman and her colleagues felt the need to “follow up the infants just to see what the outcomes are from a neurodevelopmental standpoint,” she said.
Dr. Gyamfi-Bannerman and colleagues recruited children older than age 6 from the original trial whose parents were willing to have them participate in a follow-up study. A total of 949 from the initial 2,831 cohort completed cognitive testing and received assessments for cerebral palsy, social impairment within the autism spectrum, and behavioral and emotional problems.
At the SMFM conference, Dr. Gyamfi-Bannerman reported no differences in the primary outcome of cognitive function between those whose mothers had received a single course of betamethasone and those who did not, or any differences in rates of the other outcomes.
Kathy Zhang-Rutledge, MD, a maternal-fetal medicine specialist who practices with Obstetrix Maternal Fetal Medicine Group of Houston, part of Pediatrix Medical Group, said she was glad to see a study that addressed the potential long-term adverse events associated with ACS in the late preterm period.
“Having this pretty large study – with really good neurological testing results – should help reassure clinicians that this is something they should consider adopting in their practice,” Dr. Zhang-Rutledge said.
Are boosters better?
The second unresolved question was if a repeat course of ACS should be administered when a woman at risk for preterm birth receives a course of steroids but does not deliver in the following 7 days.
Any benefits to the initial course of ACS wear off after a week. As a result, clinicians often give booster courses 7 days after the first dose if the infant is likely to be delivered in the following week. A 2009 study showed this approach may protect infants from respiratory problems, but data on long-term outcomes have been weak.
ACOG guidelines say to “consider” a booster dose in women who are less than 34 weeks’ gestation at risk for preterm delivery within 7 days.
The exception is when the mother already has experienced preterm prelabor rupture of membranes (PPROM), because ACS may increase the risk for infection for both mother and child. ACOG doesn’t take a stand on use of booster doses for PPROM, citing a lack of data to show that potential benefits outweigh the potential risks of this approach.
A recent multicenter, double-blinded, randomized clinical trial attempted to fill that void in knowledge. Between 2016 and 2022, 194 women with PPROM and gestational age less than 32 weeks who had received an initial ACS course at least 7 days prior to randomization received a booster course of ACS or saline placebo.
“Our primary outcome was designed to be like the prior rescue study (in 2009) that we did with patients with intact membranes,” said Andrew Combs, MD, PhD, a maternal-fetal medicine specialist at Pediatrix Medical Group in Sunrise, Fla., who participated in the earlier study. “It was a composite of neonatal morbidity that was any one of a variety of outcomes including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal death.”
The primary outcome occurred in 64% of women who received booster ACS and 66% with placebo (odds ratio, 0.82; 95% confidence interval, 0.43-1.57), according to Dr. Combs, who presented the findings at SMFM.
Although the study was not powered to detect significant differences in specific outcomes, the rate of neonatal sepsis was not higher in the ACS group, suggesting that ACS may be safe if membranes have ruptured, the researchers reported. But because the booster course of ACS did not prevent respiratory morbidity, clinicians may wonder what to do with the findings.
Niraj Chavan, MD, an associate professor in the department of obstetrics, gynecology, and women’s health at Saint Louis University, said he was unsure how the study would affect clinical practice.
The relatively small sample number of patients prevented analysis of specific outcomes and subgroup analyses of important variables such as race, ethnicity, gestational age, and other comorbid conditions in the mothers, he said. So clinicians still must weigh potential risks and benefits on a case-by-case basis.
“You have to think about it in buckets,” he said, “One is conditions that would increase the risk for neonatal morbidity. The other is the risk for infection, both for the mom and the baby.”
But for Dr. Combs, the interpretation of the findings was simpler: “We concluded that there’s no indication to give a booster course of steroids after a week has elapsed in patients with ruptured membranes.”
The study presented by Dr. Gyamfi-Bannerman was funded by the National Institute of Child Health and Human Development. The study presented by Dr. Combs was funded by MEDNAX Center for Research, Education, and Quality, which in 2022 was renamed Pediatrix Center for Research, Education,and Quality. Dr. Combs is an employee of Pediatrix Medical Group but has no conflicts of interest. Dr. Gyamfi-Bannerman, Dr. Zhang-Rutledge, and Dr. Chavan report no relevant financial relationships.
Ann Thomas is a pediatrician and epidemiologist in Portland, Ore.
A version of this article originally appeared on Medscape.com.
Giving corticosteroids to pregnant women at risk for preterm birth before 34 weeks of gestational age has been the standard of care since the 1990s, but a few scenarios for their use remain up for debate. Two studies presented this week at the 2023 meeting sponsored by the Society for Maternal–Fetal Medicine provided some fresh insight into the practice that could help clinicians better manage pregnant patients.
Neurodevelopmental outcomes in late preterm
First, should antenatal corticosteroids (ACS) be given to mothers who present with late preterm labor, defined as 34-36 weeks’ gestational age?
A landmark randomized clinical trial published in 2016 demonstrated that use of ACS in mothers in late preterm labor reduced severe respiratory complications. That practice has largely been adopted by clinicians. The only downside, according to the researchers, was that infants whose mothers received steroid therapy were more likely to develop hypoglycemia. The condition is self-limiting, but studies have raised concern about the potential long-term risk of neurocognitive or psychological outcomes in infants with hypoglycemia.
Cynthia Gyamfi-Bannerman, MD, MSc, endowed chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, led the 2016 study. Her team was unable to secure funding for their originally planned follow-up study of the infants 2 years later. But once the American College of Obstetricians and Gynecologists endorsed the practice and more women received ACS in the late preterm period, Dr. Gyamfi-Bannerman and her colleagues felt the need to “follow up the infants just to see what the outcomes are from a neurodevelopmental standpoint,” she said.
Dr. Gyamfi-Bannerman and colleagues recruited children older than age 6 from the original trial whose parents were willing to have them participate in a follow-up study. A total of 949 from the initial 2,831 cohort completed cognitive testing and received assessments for cerebral palsy, social impairment within the autism spectrum, and behavioral and emotional problems.
At the SMFM conference, Dr. Gyamfi-Bannerman reported no differences in the primary outcome of cognitive function between those whose mothers had received a single course of betamethasone and those who did not, or any differences in rates of the other outcomes.
Kathy Zhang-Rutledge, MD, a maternal-fetal medicine specialist who practices with Obstetrix Maternal Fetal Medicine Group of Houston, part of Pediatrix Medical Group, said she was glad to see a study that addressed the potential long-term adverse events associated with ACS in the late preterm period.
“Having this pretty large study – with really good neurological testing results – should help reassure clinicians that this is something they should consider adopting in their practice,” Dr. Zhang-Rutledge said.
Are boosters better?
The second unresolved question was if a repeat course of ACS should be administered when a woman at risk for preterm birth receives a course of steroids but does not deliver in the following 7 days.
Any benefits to the initial course of ACS wear off after a week. As a result, clinicians often give booster courses 7 days after the first dose if the infant is likely to be delivered in the following week. A 2009 study showed this approach may protect infants from respiratory problems, but data on long-term outcomes have been weak.
ACOG guidelines say to “consider” a booster dose in women who are less than 34 weeks’ gestation at risk for preterm delivery within 7 days.
The exception is when the mother already has experienced preterm prelabor rupture of membranes (PPROM), because ACS may increase the risk for infection for both mother and child. ACOG doesn’t take a stand on use of booster doses for PPROM, citing a lack of data to show that potential benefits outweigh the potential risks of this approach.
A recent multicenter, double-blinded, randomized clinical trial attempted to fill that void in knowledge. Between 2016 and 2022, 194 women with PPROM and gestational age less than 32 weeks who had received an initial ACS course at least 7 days prior to randomization received a booster course of ACS or saline placebo.
“Our primary outcome was designed to be like the prior rescue study (in 2009) that we did with patients with intact membranes,” said Andrew Combs, MD, PhD, a maternal-fetal medicine specialist at Pediatrix Medical Group in Sunrise, Fla., who participated in the earlier study. “It was a composite of neonatal morbidity that was any one of a variety of outcomes including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal death.”
The primary outcome occurred in 64% of women who received booster ACS and 66% with placebo (odds ratio, 0.82; 95% confidence interval, 0.43-1.57), according to Dr. Combs, who presented the findings at SMFM.
Although the study was not powered to detect significant differences in specific outcomes, the rate of neonatal sepsis was not higher in the ACS group, suggesting that ACS may be safe if membranes have ruptured, the researchers reported. But because the booster course of ACS did not prevent respiratory morbidity, clinicians may wonder what to do with the findings.
Niraj Chavan, MD, an associate professor in the department of obstetrics, gynecology, and women’s health at Saint Louis University, said he was unsure how the study would affect clinical practice.
The relatively small sample number of patients prevented analysis of specific outcomes and subgroup analyses of important variables such as race, ethnicity, gestational age, and other comorbid conditions in the mothers, he said. So clinicians still must weigh potential risks and benefits on a case-by-case basis.
“You have to think about it in buckets,” he said, “One is conditions that would increase the risk for neonatal morbidity. The other is the risk for infection, both for the mom and the baby.”
But for Dr. Combs, the interpretation of the findings was simpler: “We concluded that there’s no indication to give a booster course of steroids after a week has elapsed in patients with ruptured membranes.”
The study presented by Dr. Gyamfi-Bannerman was funded by the National Institute of Child Health and Human Development. The study presented by Dr. Combs was funded by MEDNAX Center for Research, Education, and Quality, which in 2022 was renamed Pediatrix Center for Research, Education,and Quality. Dr. Combs is an employee of Pediatrix Medical Group but has no conflicts of interest. Dr. Gyamfi-Bannerman, Dr. Zhang-Rutledge, and Dr. Chavan report no relevant financial relationships.
Ann Thomas is a pediatrician and epidemiologist in Portland, Ore.
A version of this article originally appeared on Medscape.com.
Giving corticosteroids to pregnant women at risk for preterm birth before 34 weeks of gestational age has been the standard of care since the 1990s, but a few scenarios for their use remain up for debate. Two studies presented this week at the 2023 meeting sponsored by the Society for Maternal–Fetal Medicine provided some fresh insight into the practice that could help clinicians better manage pregnant patients.
Neurodevelopmental outcomes in late preterm
First, should antenatal corticosteroids (ACS) be given to mothers who present with late preterm labor, defined as 34-36 weeks’ gestational age?
A landmark randomized clinical trial published in 2016 demonstrated that use of ACS in mothers in late preterm labor reduced severe respiratory complications. That practice has largely been adopted by clinicians. The only downside, according to the researchers, was that infants whose mothers received steroid therapy were more likely to develop hypoglycemia. The condition is self-limiting, but studies have raised concern about the potential long-term risk of neurocognitive or psychological outcomes in infants with hypoglycemia.
Cynthia Gyamfi-Bannerman, MD, MSc, endowed chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, led the 2016 study. Her team was unable to secure funding for their originally planned follow-up study of the infants 2 years later. But once the American College of Obstetricians and Gynecologists endorsed the practice and more women received ACS in the late preterm period, Dr. Gyamfi-Bannerman and her colleagues felt the need to “follow up the infants just to see what the outcomes are from a neurodevelopmental standpoint,” she said.
Dr. Gyamfi-Bannerman and colleagues recruited children older than age 6 from the original trial whose parents were willing to have them participate in a follow-up study. A total of 949 from the initial 2,831 cohort completed cognitive testing and received assessments for cerebral palsy, social impairment within the autism spectrum, and behavioral and emotional problems.
At the SMFM conference, Dr. Gyamfi-Bannerman reported no differences in the primary outcome of cognitive function between those whose mothers had received a single course of betamethasone and those who did not, or any differences in rates of the other outcomes.
Kathy Zhang-Rutledge, MD, a maternal-fetal medicine specialist who practices with Obstetrix Maternal Fetal Medicine Group of Houston, part of Pediatrix Medical Group, said she was glad to see a study that addressed the potential long-term adverse events associated with ACS in the late preterm period.
“Having this pretty large study – with really good neurological testing results – should help reassure clinicians that this is something they should consider adopting in their practice,” Dr. Zhang-Rutledge said.
Are boosters better?
The second unresolved question was if a repeat course of ACS should be administered when a woman at risk for preterm birth receives a course of steroids but does not deliver in the following 7 days.
Any benefits to the initial course of ACS wear off after a week. As a result, clinicians often give booster courses 7 days after the first dose if the infant is likely to be delivered in the following week. A 2009 study showed this approach may protect infants from respiratory problems, but data on long-term outcomes have been weak.
ACOG guidelines say to “consider” a booster dose in women who are less than 34 weeks’ gestation at risk for preterm delivery within 7 days.
The exception is when the mother already has experienced preterm prelabor rupture of membranes (PPROM), because ACS may increase the risk for infection for both mother and child. ACOG doesn’t take a stand on use of booster doses for PPROM, citing a lack of data to show that potential benefits outweigh the potential risks of this approach.
A recent multicenter, double-blinded, randomized clinical trial attempted to fill that void in knowledge. Between 2016 and 2022, 194 women with PPROM and gestational age less than 32 weeks who had received an initial ACS course at least 7 days prior to randomization received a booster course of ACS or saline placebo.
“Our primary outcome was designed to be like the prior rescue study (in 2009) that we did with patients with intact membranes,” said Andrew Combs, MD, PhD, a maternal-fetal medicine specialist at Pediatrix Medical Group in Sunrise, Fla., who participated in the earlier study. “It was a composite of neonatal morbidity that was any one of a variety of outcomes including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal death.”
The primary outcome occurred in 64% of women who received booster ACS and 66% with placebo (odds ratio, 0.82; 95% confidence interval, 0.43-1.57), according to Dr. Combs, who presented the findings at SMFM.
Although the study was not powered to detect significant differences in specific outcomes, the rate of neonatal sepsis was not higher in the ACS group, suggesting that ACS may be safe if membranes have ruptured, the researchers reported. But because the booster course of ACS did not prevent respiratory morbidity, clinicians may wonder what to do with the findings.
Niraj Chavan, MD, an associate professor in the department of obstetrics, gynecology, and women’s health at Saint Louis University, said he was unsure how the study would affect clinical practice.
The relatively small sample number of patients prevented analysis of specific outcomes and subgroup analyses of important variables such as race, ethnicity, gestational age, and other comorbid conditions in the mothers, he said. So clinicians still must weigh potential risks and benefits on a case-by-case basis.
“You have to think about it in buckets,” he said, “One is conditions that would increase the risk for neonatal morbidity. The other is the risk for infection, both for the mom and the baby.”
But for Dr. Combs, the interpretation of the findings was simpler: “We concluded that there’s no indication to give a booster course of steroids after a week has elapsed in patients with ruptured membranes.”
The study presented by Dr. Gyamfi-Bannerman was funded by the National Institute of Child Health and Human Development. The study presented by Dr. Combs was funded by MEDNAX Center for Research, Education, and Quality, which in 2022 was renamed Pediatrix Center for Research, Education,and Quality. Dr. Combs is an employee of Pediatrix Medical Group but has no conflicts of interest. Dr. Gyamfi-Bannerman, Dr. Zhang-Rutledge, and Dr. Chavan report no relevant financial relationships.
Ann Thomas is a pediatrician and epidemiologist in Portland, Ore.
A version of this article originally appeared on Medscape.com.
FROM THE PREGNANCY MEETING
NICU use up, birth weights down in babies of mothers with HCV
Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity.
Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.
As Dr. Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.”
For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001).
The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity.
An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Dr. Hughes said.
There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34).
No difference in outcomes was seen when HCV cases with viremia (33%) were excluded.
“The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Dr. Hughes said.
She added it’s not clear why NICU stays and low birth weights were more common in infants of women with HCV. “It is possible that the higher risk of need for higher-level pediatric care was related to a need for observation or treatment due to use of opioid replacement therapies with opioid agonists.” As for lower birth weight, “there may be other unmeasured risk factors.”
Tatyana Kushner, MD, MSCE, of the division of liver diseases at Icahn School of Medicine at Mount Sinai, New York, said in an interview that the study adds to limited data about HCV in pregnancy. “These findings have been demonstrated in prior studies, and it would be important to tease apart whether [low birth weight] is related to the virus itself or more related to other confounding associated factors such as maternal substance use as well as other associated social determinants of health among women with HCV.”
As for the study’s message, Dr. Kushner said it makes it clear that “hepatitis C adversely impacts outcomes of pregnancy and it is important to identify women of childbearing age for treatment early, ideally prior to pregnancy, in order to improve their pregnancy outcomes. In addition, treatment of hepatitis C during pregnancy should be explored further to determine if treatment during pregnancy can improve outcomes.”
At the moment, she said, “there are ongoing studies to delineate the safety and efficacy of hepatitis C treatment during pregnancy. Given that we are screening for hepatitis C during pregnancy, we need clear recommendations on the use of direct-acting antivirals in people who screen positive.”
The study was funded by the National Institute of Child Health and Human Development. The authors have no disclosures. Dr. Kushner disclosed research support (Gilead) and advisory board service (Gilead, AbbVie, Bausch, GlaxoSmithKline, and Eiger).
Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity.
Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.
As Dr. Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.”
For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001).
The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity.
An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Dr. Hughes said.
There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34).
No difference in outcomes was seen when HCV cases with viremia (33%) were excluded.
“The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Dr. Hughes said.
She added it’s not clear why NICU stays and low birth weights were more common in infants of women with HCV. “It is possible that the higher risk of need for higher-level pediatric care was related to a need for observation or treatment due to use of opioid replacement therapies with opioid agonists.” As for lower birth weight, “there may be other unmeasured risk factors.”
Tatyana Kushner, MD, MSCE, of the division of liver diseases at Icahn School of Medicine at Mount Sinai, New York, said in an interview that the study adds to limited data about HCV in pregnancy. “These findings have been demonstrated in prior studies, and it would be important to tease apart whether [low birth weight] is related to the virus itself or more related to other confounding associated factors such as maternal substance use as well as other associated social determinants of health among women with HCV.”
As for the study’s message, Dr. Kushner said it makes it clear that “hepatitis C adversely impacts outcomes of pregnancy and it is important to identify women of childbearing age for treatment early, ideally prior to pregnancy, in order to improve their pregnancy outcomes. In addition, treatment of hepatitis C during pregnancy should be explored further to determine if treatment during pregnancy can improve outcomes.”
At the moment, she said, “there are ongoing studies to delineate the safety and efficacy of hepatitis C treatment during pregnancy. Given that we are screening for hepatitis C during pregnancy, we need clear recommendations on the use of direct-acting antivirals in people who screen positive.”
The study was funded by the National Institute of Child Health and Human Development. The authors have no disclosures. Dr. Kushner disclosed research support (Gilead) and advisory board service (Gilead, AbbVie, Bausch, GlaxoSmithKline, and Eiger).
Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity.
Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.
As Dr. Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.”
For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001).
The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity.
An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Dr. Hughes said.
There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34).
No difference in outcomes was seen when HCV cases with viremia (33%) were excluded.
“The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Dr. Hughes said.
She added it’s not clear why NICU stays and low birth weights were more common in infants of women with HCV. “It is possible that the higher risk of need for higher-level pediatric care was related to a need for observation or treatment due to use of opioid replacement therapies with opioid agonists.” As for lower birth weight, “there may be other unmeasured risk factors.”
Tatyana Kushner, MD, MSCE, of the division of liver diseases at Icahn School of Medicine at Mount Sinai, New York, said in an interview that the study adds to limited data about HCV in pregnancy. “These findings have been demonstrated in prior studies, and it would be important to tease apart whether [low birth weight] is related to the virus itself or more related to other confounding associated factors such as maternal substance use as well as other associated social determinants of health among women with HCV.”
As for the study’s message, Dr. Kushner said it makes it clear that “hepatitis C adversely impacts outcomes of pregnancy and it is important to identify women of childbearing age for treatment early, ideally prior to pregnancy, in order to improve their pregnancy outcomes. In addition, treatment of hepatitis C during pregnancy should be explored further to determine if treatment during pregnancy can improve outcomes.”
At the moment, she said, “there are ongoing studies to delineate the safety and efficacy of hepatitis C treatment during pregnancy. Given that we are screening for hepatitis C during pregnancy, we need clear recommendations on the use of direct-acting antivirals in people who screen positive.”
The study was funded by the National Institute of Child Health and Human Development. The authors have no disclosures. Dr. Kushner disclosed research support (Gilead) and advisory board service (Gilead, AbbVie, Bausch, GlaxoSmithKline, and Eiger).
FROM THE PREGNANCY MEETING
Scientists create ‘vagina on a chip’: What to know
For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen.
“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments.
By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow.
The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease.
Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer.
The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.
No other preclinical model exists to perform tests like that, says Dr. Ingber.
“The vagina chip is a way to help make some advances,” he says.
The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science.
“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.
Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.
That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium.
It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard.
“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.”
As such, the vagina chip could help scientists find new treatments much faster.
Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.
“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.
Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says. Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.
While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences.
“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.
To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract.
The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.
“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.”
As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.
“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.
Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health.
A version of this article first appeared on WebMD.com.
For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen.
“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments.
By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow.
The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease.
Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer.
The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.
No other preclinical model exists to perform tests like that, says Dr. Ingber.
“The vagina chip is a way to help make some advances,” he says.
The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science.
“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.
Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.
That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium.
It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard.
“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.”
As such, the vagina chip could help scientists find new treatments much faster.
Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.
“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.
Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says. Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.
While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences.
“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.
To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract.
The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.
“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.”
As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.
“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.
Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health.
A version of this article first appeared on WebMD.com.
For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen.
“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments.
By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow.
The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease.
Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer.
The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.
No other preclinical model exists to perform tests like that, says Dr. Ingber.
“The vagina chip is a way to help make some advances,” he says.
The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science.
“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.
Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.
That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium.
It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard.
“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.”
As such, the vagina chip could help scientists find new treatments much faster.
Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.
“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.
Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says. Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.
While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences.
“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.
To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract.
The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.
“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.”
As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.
“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.
Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health.
A version of this article first appeared on WebMD.com.
FROM MICROBIOME
Vacuum device for postpartum hemorrhage works well in real world
Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York, who presented the findings.
Dr. Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The U.S. Food and Drug Administration approved use of the Jada System in October 2020.
Dr. Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 U.S. medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.
Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.
Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.
Dr. Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Dr. Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower-income countries. Dr. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.
Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Dr. Goffman, she was excited to have a new tool for treating a life-threatening condition.
Although the device has been on the market for more than 2 years, Dr. Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.
“We should make sure that it’s effective, and we should know what the safety profile is,” said Dr. Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”
Both Dr. Goffman and Dr. Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.
“We should be supporting further investigation,” Dr. Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”
The study was funded by Alydia Health, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Dr. Goffman serves on the scientific advisory board of Alydia Health/Organon. Dr. Samuel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York, who presented the findings.
Dr. Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The U.S. Food and Drug Administration approved use of the Jada System in October 2020.
Dr. Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 U.S. medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.
Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.
Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.
Dr. Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Dr. Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower-income countries. Dr. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.
Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Dr. Goffman, she was excited to have a new tool for treating a life-threatening condition.
Although the device has been on the market for more than 2 years, Dr. Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.
“We should make sure that it’s effective, and we should know what the safety profile is,” said Dr. Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”
Both Dr. Goffman and Dr. Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.
“We should be supporting further investigation,” Dr. Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”
The study was funded by Alydia Health, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Dr. Goffman serves on the scientific advisory board of Alydia Health/Organon. Dr. Samuel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Postpartum hemorrhage is the leading cause of maternal mortality worldwide, accounting for 25% of deaths from obstetric causes. Although balloon tamponade has been widely used to manage uncontrolled postpartum bleeding, a recent evaluation of an intrauterine vacuum-induced hemorrhage control device demonstrated impressive safety and effectiveness, researchers reported at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“It’s exciting to see new technology and new potential treatment modalities. We just don’t have that many tools in our toolkit right now,” said Dena Goffman, MD, professor of women’s health and obstetrics and gynecology and vice chair of quality and patient safety at Columbia University’s Irving Medical Center, in New York, who presented the findings.
Dr. Goffman led an earlier multicenter prospective single-arm treatment study of the Jada System, a vacuum device marketed by Organon. The U.S. Food and Drug Administration approved use of the Jada System in October 2020.
Dr. Goffman said she and her colleagues felt “a next logical step would be to see what happens with real-world use.” In the new study, researchers at 16 U.S. medical centers reviewed medical charts of 800 women who underwent treatment with the Jada System between October 2020 and April 2022.
Treatment was successful in 92.5% of the vaginal births (n = 530) and 83.7% of the cesarean births (n = 270), similar to the results of the initial treatment trial that led to FDA approval, according to the researchers. For both types of delivery, bleeding was controlled in less than 5 minutes for most patients. Three serious adverse events were identified that could have been related to use of the device (two in vaginal births, one in cesarean birth), they reported.
Although the study was not designed to directly compare the Jada System with balloon tamponade, in a recent meta-analysis, it was estimated that tamponade controls postpartum hemorrhage in roughly 87% of cases, with complication rates in as many as 6.5% among women who undergo the procedure.
Dr. Goffman pointed out additional benefits. The vacuum device typically must stay in place for less time (3.1 hours for vaginal birth and 4.6 hours for cesarean birth) than balloon tamponade, allowing women to recover more quickly. In the initial trial, which Dr. Goffman helped conduct, 98% of clinicians reported that the device was easy to use, which increases its attractiveness in lower-income countries. Dr. Goffman felt that the device “has potential for huge impact” in those countries, given the high rates of maternal morbidity and mortality in these areas.
Amber Samuel, MD, medical director of OBSETRIX Maternal Fetal Medicine Specialists of Houston, said the device recently became available in the hospitals in which she works, and she has used the Jada System several times. Like Dr. Goffman, she was excited to have a new tool for treating a life-threatening condition.
Although the device has been on the market for more than 2 years, Dr. Samuel felt clinicians who were reluctant to adopt a new technology would be reassured by the findings.
“We should make sure that it’s effective, and we should know what the safety profile is,” said Dr. Samuel, adding that “the more data we have, the more we’re able to counsel patients and work this into our protocols for what is a really common obstetric problem.”
Both Dr. Goffman and Dr. Samuel agreed that more data, ideally from randomized clinical trials, are needed to convince professional groups such as the American College of Obstetricians and Gynecologists to state a clear preference for use of vacuum-induced hemorrhage control devices over balloon tamponade.
“We should be supporting further investigation,” Dr. Goffman said, “but for people who have this tool available to them now, I think they can feel confident in using it.”
The study was funded by Alydia Health, the manufacturer of the Jada System. Alydia Health was acquired by Organon in 2021. Study sites received research-related financial support, but none of the authors received direct payments from Alydia Health/Organon. Dr. Goffman serves on the scientific advisory board of Alydia Health/Organon. Dr. Samuel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE PREGNANCY MEETING
More evidence suggests oxytocin can be discontinued early in labor
A new randomized, open-label French trial offers more evidence that the discontinuation of oxytocin treatment after the earliest stages of labor may be safe. Stopping oxytocin didn’t appear to affect neonatal outcomes, compared with continual use of the medication. However, the first stage of labor lasted slightly longer – not surprisingly – in those in the intervention group, and many of those who stopped oxytocin treatment resumed it later.
“Our trial did not show any impact of oxytocin discontinuation in the active [labor] stage on neonatal morbidity cesarean delivery, postpartum hemorrhage, birth experience, and postpartum depression,” said Aude Girault, MD, PhD, of Paris Cité University, in a presentation in San Francisco at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The goal of the STOPOXY study is to build upon previous research that found oxytocin discontinuation didn’t boost the risk of cesarean delivery rates, uterine hyperstimulation, and abnormal fetal heart rate, Dr. Girault said. “These studies were underpowered to show any effects on neonatal morbidity,” so she and colleagues decided to dig deeper into the issue by launching the new trial.
From 2020 to 2022, researchers assigned 2,367 women who received oxytocin before 4 centimeters dilation to either continue with the drug (n = 1,192) or discontinue it before reaching 6 centimeters dilation (n = 1,175). Overall, the women were pregnant for the first time (around 55%) with a median age around 32 years and body mass index around 24.1 kg/m2. All had live, singleton, full-term babies.
More than a third – 37% – of those who discontinued oxytocin resumed treatment with the medication, while 5% of those in the control group stopped taking it.
The neonatal morbidity rate – defined via a composite variable based on umbilical arterial pH, umbilical arterial lactates, Apgar score, and/or neonatal ICU admission – was 10.0% in the intervention group and 10.1% in the control group (P = .94), the researchers reported. Cesarean delivery rates were similar (18.8% vs. 16.5%, respectively; P = .22). Apart from the duration of the active first stage, which was significantly higher in the intervention group (100 min [ interquartile range, 50-208 min] vs. 90 min [IQR, 45-150 min]; P = .001), there were no significant differences between the groups.
Dr. Girault said this increase in labor duration was “moderate and clinically debatable.”
In an interview, oncologist-gynecologist George Saade, MD, of the University of Texas Medical Branch, Galveston, noted that “oxytocin is frequently used for either induction or augmentation of labor ... with the goal of improving maternal and neonatal outcomes.”
Oxytocin itself is not expensive, Dr. Saade said. “However, when it is given, the patient requires more monitoring, which may increase cost.”
There’s debate over the proper use of oxytocin, which is available in a synthetic version as Pitocin, and researchers have been trying to understand whether it can safely be discontinued early in labor.
Potential side effects of oxytocin include heart disorders such as arrhythmia, asphyxia, neonatal seizure, and jaundice, low Apgar score, and fetal death. A boxed warning says: “Because the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.”
However, “overall oxytocin is commonly used and very safe as long as careful protocols are followed,” David N. Hackney, MD, MS, of University Hospitals Cleveland, said in an interview. “The medication itself does not have many negative side effects. With very high doses there can be a concern for water intoxication, though this is clinically very uncommon. Some prior studies have raised concerns about the use of oxytocin and subsequent long-term neurodevelopmental outcomes, though these associations are likely confounders and the mainstream opinion is that these are not truly biologically causative associations.”
A 2021 study in The BMJ randomly assigned 1,200 women to continue or discontinue oxytocin. There was a slight increase in cesarean sections in the discontinuation group but significantly lower risks of uterine hyperstimulation and abnormal fetal heart rate.
Dr. Hackney, who didn’t take part in the new study, said the trial is “well conducted and well executed.” However, it needs peer review before any of its findings should change practice.
He added that differences in delivery protocols between the United States and France should be considered. As he noted, Dr. Girault mentioned in a Q&A after her presentation that delayed second-stage labor is more common in France than in the United States.
The study was funded by the French National Ministry of Health. Disclosures for the authors were not provided. Dr. Saade and Dr. Hackney have no disclosures.
A new randomized, open-label French trial offers more evidence that the discontinuation of oxytocin treatment after the earliest stages of labor may be safe. Stopping oxytocin didn’t appear to affect neonatal outcomes, compared with continual use of the medication. However, the first stage of labor lasted slightly longer – not surprisingly – in those in the intervention group, and many of those who stopped oxytocin treatment resumed it later.
“Our trial did not show any impact of oxytocin discontinuation in the active [labor] stage on neonatal morbidity cesarean delivery, postpartum hemorrhage, birth experience, and postpartum depression,” said Aude Girault, MD, PhD, of Paris Cité University, in a presentation in San Francisco at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The goal of the STOPOXY study is to build upon previous research that found oxytocin discontinuation didn’t boost the risk of cesarean delivery rates, uterine hyperstimulation, and abnormal fetal heart rate, Dr. Girault said. “These studies were underpowered to show any effects on neonatal morbidity,” so she and colleagues decided to dig deeper into the issue by launching the new trial.
From 2020 to 2022, researchers assigned 2,367 women who received oxytocin before 4 centimeters dilation to either continue with the drug (n = 1,192) or discontinue it before reaching 6 centimeters dilation (n = 1,175). Overall, the women were pregnant for the first time (around 55%) with a median age around 32 years and body mass index around 24.1 kg/m2. All had live, singleton, full-term babies.
More than a third – 37% – of those who discontinued oxytocin resumed treatment with the medication, while 5% of those in the control group stopped taking it.
The neonatal morbidity rate – defined via a composite variable based on umbilical arterial pH, umbilical arterial lactates, Apgar score, and/or neonatal ICU admission – was 10.0% in the intervention group and 10.1% in the control group (P = .94), the researchers reported. Cesarean delivery rates were similar (18.8% vs. 16.5%, respectively; P = .22). Apart from the duration of the active first stage, which was significantly higher in the intervention group (100 min [ interquartile range, 50-208 min] vs. 90 min [IQR, 45-150 min]; P = .001), there were no significant differences between the groups.
Dr. Girault said this increase in labor duration was “moderate and clinically debatable.”
In an interview, oncologist-gynecologist George Saade, MD, of the University of Texas Medical Branch, Galveston, noted that “oxytocin is frequently used for either induction or augmentation of labor ... with the goal of improving maternal and neonatal outcomes.”
Oxytocin itself is not expensive, Dr. Saade said. “However, when it is given, the patient requires more monitoring, which may increase cost.”
There’s debate over the proper use of oxytocin, which is available in a synthetic version as Pitocin, and researchers have been trying to understand whether it can safely be discontinued early in labor.
Potential side effects of oxytocin include heart disorders such as arrhythmia, asphyxia, neonatal seizure, and jaundice, low Apgar score, and fetal death. A boxed warning says: “Because the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.”
However, “overall oxytocin is commonly used and very safe as long as careful protocols are followed,” David N. Hackney, MD, MS, of University Hospitals Cleveland, said in an interview. “The medication itself does not have many negative side effects. With very high doses there can be a concern for water intoxication, though this is clinically very uncommon. Some prior studies have raised concerns about the use of oxytocin and subsequent long-term neurodevelopmental outcomes, though these associations are likely confounders and the mainstream opinion is that these are not truly biologically causative associations.”
A 2021 study in The BMJ randomly assigned 1,200 women to continue or discontinue oxytocin. There was a slight increase in cesarean sections in the discontinuation group but significantly lower risks of uterine hyperstimulation and abnormal fetal heart rate.
Dr. Hackney, who didn’t take part in the new study, said the trial is “well conducted and well executed.” However, it needs peer review before any of its findings should change practice.
He added that differences in delivery protocols between the United States and France should be considered. As he noted, Dr. Girault mentioned in a Q&A after her presentation that delayed second-stage labor is more common in France than in the United States.
The study was funded by the French National Ministry of Health. Disclosures for the authors were not provided. Dr. Saade and Dr. Hackney have no disclosures.
A new randomized, open-label French trial offers more evidence that the discontinuation of oxytocin treatment after the earliest stages of labor may be safe. Stopping oxytocin didn’t appear to affect neonatal outcomes, compared with continual use of the medication. However, the first stage of labor lasted slightly longer – not surprisingly – in those in the intervention group, and many of those who stopped oxytocin treatment resumed it later.
“Our trial did not show any impact of oxytocin discontinuation in the active [labor] stage on neonatal morbidity cesarean delivery, postpartum hemorrhage, birth experience, and postpartum depression,” said Aude Girault, MD, PhD, of Paris Cité University, in a presentation in San Francisco at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The goal of the STOPOXY study is to build upon previous research that found oxytocin discontinuation didn’t boost the risk of cesarean delivery rates, uterine hyperstimulation, and abnormal fetal heart rate, Dr. Girault said. “These studies were underpowered to show any effects on neonatal morbidity,” so she and colleagues decided to dig deeper into the issue by launching the new trial.
From 2020 to 2022, researchers assigned 2,367 women who received oxytocin before 4 centimeters dilation to either continue with the drug (n = 1,192) or discontinue it before reaching 6 centimeters dilation (n = 1,175). Overall, the women were pregnant for the first time (around 55%) with a median age around 32 years and body mass index around 24.1 kg/m2. All had live, singleton, full-term babies.
More than a third – 37% – of those who discontinued oxytocin resumed treatment with the medication, while 5% of those in the control group stopped taking it.
The neonatal morbidity rate – defined via a composite variable based on umbilical arterial pH, umbilical arterial lactates, Apgar score, and/or neonatal ICU admission – was 10.0% in the intervention group and 10.1% in the control group (P = .94), the researchers reported. Cesarean delivery rates were similar (18.8% vs. 16.5%, respectively; P = .22). Apart from the duration of the active first stage, which was significantly higher in the intervention group (100 min [ interquartile range, 50-208 min] vs. 90 min [IQR, 45-150 min]; P = .001), there were no significant differences between the groups.
Dr. Girault said this increase in labor duration was “moderate and clinically debatable.”
In an interview, oncologist-gynecologist George Saade, MD, of the University of Texas Medical Branch, Galveston, noted that “oxytocin is frequently used for either induction or augmentation of labor ... with the goal of improving maternal and neonatal outcomes.”
Oxytocin itself is not expensive, Dr. Saade said. “However, when it is given, the patient requires more monitoring, which may increase cost.”
There’s debate over the proper use of oxytocin, which is available in a synthetic version as Pitocin, and researchers have been trying to understand whether it can safely be discontinued early in labor.
Potential side effects of oxytocin include heart disorders such as arrhythmia, asphyxia, neonatal seizure, and jaundice, low Apgar score, and fetal death. A boxed warning says: “Because the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.”
However, “overall oxytocin is commonly used and very safe as long as careful protocols are followed,” David N. Hackney, MD, MS, of University Hospitals Cleveland, said in an interview. “The medication itself does not have many negative side effects. With very high doses there can be a concern for water intoxication, though this is clinically very uncommon. Some prior studies have raised concerns about the use of oxytocin and subsequent long-term neurodevelopmental outcomes, though these associations are likely confounders and the mainstream opinion is that these are not truly biologically causative associations.”
A 2021 study in The BMJ randomly assigned 1,200 women to continue or discontinue oxytocin. There was a slight increase in cesarean sections in the discontinuation group but significantly lower risks of uterine hyperstimulation and abnormal fetal heart rate.
Dr. Hackney, who didn’t take part in the new study, said the trial is “well conducted and well executed.” However, it needs peer review before any of its findings should change practice.
He added that differences in delivery protocols between the United States and France should be considered. As he noted, Dr. Girault mentioned in a Q&A after her presentation that delayed second-stage labor is more common in France than in the United States.
The study was funded by the French National Ministry of Health. Disclosures for the authors were not provided. Dr. Saade and Dr. Hackney have no disclosures.
FROM THE PREGNANCY MEETING
USPSTF backs screening for hypertensive disorders of pregnancy
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.
All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.
“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.
In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.
“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.
The draft recommendation statement was published online .
Screening recommendation
Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.
The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.
After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”
The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.
Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.
In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.
Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.
Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.
“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
Additional considerations
The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.
Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.
Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.
The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.
“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”
The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.
No relevant financial relationships have been disclosed.
A version of this article originally appeared on Medscape.com.
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.
All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.
“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.
In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.
“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.
The draft recommendation statement was published online .
Screening recommendation
Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.
The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.
After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”
The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.
Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.
In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.
Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.
Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.
“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
Additional considerations
The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.
Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.
Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.
The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.
“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”
The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.
No relevant financial relationships have been disclosed.
A version of this article originally appeared on Medscape.com.
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen for hypertensive disorders of pregnancy, which can cause serious and fatal complications, according to a new draft statement.
All pregnant people should have their blood pressure measured at each prenatal visit to identify and prevent serious health problems. The grade B recommendation expands on the task force’s 2017 recommendation on screening for preeclampsia to include all hypertensive disorders of pregnancy.
“Hypertensive disorders of pregnancy are some of the leading causes of serious complications and death for pregnant people,” Esa Davis, MD, a USPSTF member and associate professor of medicine and clinical and translational science at the University of Pittsburgh School of Medicine, told this news organization.
In the U.S., the rate of hypertensive disorders of pregnancy has increased in recent decades, jumping from about 500 cases per 10,000 deliveries in the early 1990s to more than 1,000 cases per 10,000 deliveries in the mid-2010s.
“The U.S. Preventive Services Task Force wants to help save the lives of pregnant people and their babies by ensuring that clinicians have the most up-to-date guidance on how to find these conditions early,” she said.
The draft recommendation statement was published online .
Screening recommendation
Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with and without superimposed preeclampsia, are marked by elevated blood pressure during pregnancy.
The disorders can lead to complications for the pregnant person, such as stroke, retinal detachment, organ damage or failure, and seizures, as well as for the baby, including restricted growth, low birth weight, and stillbirth. Many complications can lead to early induction of labor, cesarean delivery, and preterm birth.
After commissioning a systematic evidence review, the USPSTF provided a grade B recommendation for clinicians to offer or provide screening for hypertensive disorders of pregnancy. The recommendation concludes with “moderate certainty” that screening with blood pressure measurements has “substantial net benefit.”
The task force notes that it is “essential” for all pregnant women and pregnant people of all genders to be screened and that those who screen positive receive evidence-based management of their condition.
Risk factors include a history of eclampsia or preeclampsia, a family history of preeclampsia, a previous adverse pregnancy outcome, having gestational diabetes or chronic hypertension, being pregnant with more than one baby, having a first pregnancy, having a high body mass index prior to pregnancy, and being 35 years of age or older.
In addition, Black, American Indian, and Alaska Native people face higher risks and are more likely both to have and to die from a hypertensive disorder of pregnancy. In particular, Black people experience higher rates of maternal and infant morbidity and perinatal mortality than other racial and ethnic groups, and hypertensive disorders of pregnancy account for a larger proportion of these outcomes.
Although measuring blood pressure throughout pregnancy is an important first step, it’s not enough to improve inequities in health outcomes, the task force notes. Identifying hypertensive disorders of pregnancy requires adequate prenatal follow-up visits, surveillance, and evidence-based care, which can be a barrier for some pregnant people.
Follow-up visits with health care providers such as nurses, nurse midwives, pediatricians, and lactation consultants could help, as well as screening and monitoring during the postpartum period. Other approaches include telehealth, connections to community resources during the perinatal period, collaborative care provided in medical homes, and multilevel interventions to address underlying health inequities that increase health risks during pregnancy.
“Since screening is not enough to address the health disparities experienced by Black, American Indian, and Alaska Native people, health care professionals should also do what they can to help address these inequities,” Dr. Davis said. “For example, the task force identified a few promising approaches, including using standardized clinical bundles of best practices for disease management to help ensure that all pregnant persons receive appropriate, equitable care.”
Additional considerations
The USPSTF looked at the evidence on additional methods of screening but continued to find that measuring blood pressure at each prenatal visit is the best approach. Other evaluations, such as testing for proteinuria when preeclampsia is suspected, have low accuracy for detecting proteinuria in pregnancy.
Although there is no currently available treatment for preeclampsia except delivery, management strategies for diagnosed hypertensive disorders of pregnancy include close fetal and maternal monitoring, antihypertension medications, and magnesium sulfate for seizure prophylaxis when indicated.
Previously, the USPSTF also recommended that pregnant Black people be considered for treatment with low-dose aspirin to prevent preeclampsia, with aspirin use recommended for those with at least one additional moderate risk factor. Clinicians should also be aware of the complications of poor health outcomes among populations who face higher risks.
The USPSTF noted several gaps for future research, including the best approaches for blood pressure monitoring during pregnancy and the postpartum period, how to address health inequities through multilevel interventions, how to increase access to care through telehealth services, and how to mitigate cardiovascular complications later in life in patients diagnosed with hypertensive disorders of pregnancy.
“Continued research is needed in these promising areas,” Dr. Davis said. “We hope all clinicians will join us in helping ensure that all parents and babies have access to the care they need to be as healthy as possible.”
The draft recommendation statement and draft evidence review were posted for public comment on the USPSTF website. Comments can be submitted until March 6.
No relevant financial relationships have been disclosed.
A version of this article originally appeared on Medscape.com.
Three wild technologies about to change health care
When I was a child, I watched syndicated episodes of the original “Star Trek.” I was dazzled by the space travel, sure, but also the medical technology.
A handheld “tricorder” detected diseases, while an intramuscular injector (“hypospray”) could treat them. Sickbay “biobeds” came with real-time health monitors that looked futuristic at the time but seem primitive today.
Such visions inspired a lot of us kids to pursue science. Little did we know the real-life advances many of us would see in our lifetimes.
Artificial intelligence helping to spot disease, robots performing surgery, even video calls between doctor and patient – all these once sounded fantastical but now happen in clinical care.
Now, in the 23rd year of the 21st century, you might not believe wht we’ll be capable of next. Three especially wild examples are moving closer to clinical reality.
Human hibernation
Captain America, Han Solo, and “Star Trek” villain Khan – all were preserved at low temperatures and then revived, waking up alive and well months, decades, or centuries later. These are fictional examples, to be sure, but the science they’re rooted in is real.
(In one extreme case, a climber survived after almost 9 hours of efforts to revive him.)
Useful for a space traveler? Maybe not. But it’s potentially huge for someone with life-threatening injuries from a car accident or a gunshot wound.
That’s the thinking behind a breakthrough procedure that came after decades of research on pigs and dogs, now in a clinical trial. The idea: A person with massive blood loss whose heart has stopped is injected with an ice-cold fluid, cooling them from the inside, down to about 50° F.
Doctors already induce more modest hypothermia to protect the brain and other organs after cardiac arrest and during surgery on the aortic arch (the main artery carrying blood from the heart).
But this experimental procedure – called emergency preservation and resuscitation (EPR) – goes far beyond that, dramatically “decreasing the body’s need for oxygen and blood flow,” says Samuel Tisherman, MD, a trauma surgeon at the University of Maryland Medical Center and the trial’s lead researcher. This puts the patient in a state of suspended animation that “could buy time for surgeons to stop the bleeding and save more of these patients.”
The technique has been done on at least six patients, though none were reported to survive. The trial is expected to include 20 people by the time it wraps up in December, according to the listing on the U.S. clinical trials database. Though given the strict requirements for candidates (emergency trauma victims who are not likely to survive), one can’t exactly rely on a set schedule.
Still, the technology is promising. Someday we may even use it to keep patients in suspended animation for months or years, experts predict, helping astronauts through decades-long spaceflights, or stalling death in sick patients awaiting a cure.
Artificial womb
Another sci-fi classic: growing human babies outside the womb. Think the fetus fields from “The Matrix,” or the frozen embryos in “Alien: Covenant.”
In 1923, British biologist J.B.S. Haldane coined a term for that – ectogenesis. He predicted that 70% of pregnancies would take place, from fertilization to birth, in artificial wombs by 2074. That many seems unlikely, but the timeline is on track.
Developing an embryo outside the womb is already routine in in vitro fertilization. And technology enables preterm babies to survive through much of the second half of gestation. Normal human pregnancy is 40 weeks, and the youngest preterm baby ever to survive was 21 weeks and 1 day old, just a few days younger than a smattering of others who lived.
The biggest obstacle for babies younger than that is lung viability. Mechanical ventilation can damage the lungs and lead to a chronic (sometimes fatal) lung disease known as bronchopulmonary dysplasia. Avoiding this would mean figuring out a way to maintain fetal circulation – the intricate system that delivers oxygenated blood from the placenta to the fetus via the umbilical cord. Researchers at Children’s Hospital of Philadelphia have done this using a fetal lamb.
The key to their invention is a substitute placenta: an oxygenator connected to the lamb’s umbilical cord. Tubes inserted through the umbilical vein and arteries carry oxygenated blood from the “placenta” to the fetus, and deoxygenated blood back out. The lamb resides in an artificial, fluid-filled amniotic sac until its lungs and other organs are developed.
Fertility treatment could benefit, too. “An artificial womb may substitute in situations in which a gestational carrier – surrogate – is indicated,” says Paula Amato, MD, a professor of obstetrics and gynecology at Oregon Health and Science University, Portland. (Dr. Amato is not involved in the CHOP research.) For example: when the mother is missing a uterus or can’t carry a pregnancy safely.
No date is set for clinical trials yet. But according to the research, the main difference between human and lamb may come down to size. A lamb’s umbilical vessels are larger, so feeding in a tube is easier. With today’s advances in miniaturizing surgical methods, that seems like a challenge scientists can overcome.
Messenger RNA therapeutics
Back to “Star Trek.” The hypospray injector’s contents could cure just about any disease, even one newly discovered on a strange planet. That’s not unlike messenger RNA (mRNA) technology, a breakthrough that enabled scientists to quickly develop some of the first COVID-19 vaccines.
But vaccines are just the beginning of what this technology can do.
A whole field of immunotherapy is emerging that uses mRNA to deliver instructions to produce chimeric antigen receptor–modified immune cells (CAR-modified immune cells). These cells are engineered to target diseased cells and tissues, like cancer cells and harmful fibroblasts (scar tissue) that promote fibrosis in, for example, the heart and lungs.
The field is bursting with rodent research, and clinical trials have started for treating some advanced-stage malignancies.
Actual clinical use may be years away, but if all goes well, these medicines could help treat or even cure the core medical problems facing humanity. We’re talking cancer, heart disease, neurodegenerative disease – transforming one therapy into another by simply changing the mRNA’s “nucleotide sequence,” the blueprint containing instructions telling it what to do, and what disease to attack.
As this technology matures, we may start to feel as if we’re really on “Star Trek,” where Dr. Leonard “Bones” McCoy pulls out the same device to treat just about every disease or injury.
A version of this article first appeared on WebMD.com.
When I was a child, I watched syndicated episodes of the original “Star Trek.” I was dazzled by the space travel, sure, but also the medical technology.
A handheld “tricorder” detected diseases, while an intramuscular injector (“hypospray”) could treat them. Sickbay “biobeds” came with real-time health monitors that looked futuristic at the time but seem primitive today.
Such visions inspired a lot of us kids to pursue science. Little did we know the real-life advances many of us would see in our lifetimes.
Artificial intelligence helping to spot disease, robots performing surgery, even video calls between doctor and patient – all these once sounded fantastical but now happen in clinical care.
Now, in the 23rd year of the 21st century, you might not believe wht we’ll be capable of next. Three especially wild examples are moving closer to clinical reality.
Human hibernation
Captain America, Han Solo, and “Star Trek” villain Khan – all were preserved at low temperatures and then revived, waking up alive and well months, decades, or centuries later. These are fictional examples, to be sure, but the science they’re rooted in is real.
(In one extreme case, a climber survived after almost 9 hours of efforts to revive him.)
Useful for a space traveler? Maybe not. But it’s potentially huge for someone with life-threatening injuries from a car accident or a gunshot wound.
That’s the thinking behind a breakthrough procedure that came after decades of research on pigs and dogs, now in a clinical trial. The idea: A person with massive blood loss whose heart has stopped is injected with an ice-cold fluid, cooling them from the inside, down to about 50° F.
Doctors already induce more modest hypothermia to protect the brain and other organs after cardiac arrest and during surgery on the aortic arch (the main artery carrying blood from the heart).
But this experimental procedure – called emergency preservation and resuscitation (EPR) – goes far beyond that, dramatically “decreasing the body’s need for oxygen and blood flow,” says Samuel Tisherman, MD, a trauma surgeon at the University of Maryland Medical Center and the trial’s lead researcher. This puts the patient in a state of suspended animation that “could buy time for surgeons to stop the bleeding and save more of these patients.”
The technique has been done on at least six patients, though none were reported to survive. The trial is expected to include 20 people by the time it wraps up in December, according to the listing on the U.S. clinical trials database. Though given the strict requirements for candidates (emergency trauma victims who are not likely to survive), one can’t exactly rely on a set schedule.
Still, the technology is promising. Someday we may even use it to keep patients in suspended animation for months or years, experts predict, helping astronauts through decades-long spaceflights, or stalling death in sick patients awaiting a cure.
Artificial womb
Another sci-fi classic: growing human babies outside the womb. Think the fetus fields from “The Matrix,” or the frozen embryos in “Alien: Covenant.”
In 1923, British biologist J.B.S. Haldane coined a term for that – ectogenesis. He predicted that 70% of pregnancies would take place, from fertilization to birth, in artificial wombs by 2074. That many seems unlikely, but the timeline is on track.
Developing an embryo outside the womb is already routine in in vitro fertilization. And technology enables preterm babies to survive through much of the second half of gestation. Normal human pregnancy is 40 weeks, and the youngest preterm baby ever to survive was 21 weeks and 1 day old, just a few days younger than a smattering of others who lived.
The biggest obstacle for babies younger than that is lung viability. Mechanical ventilation can damage the lungs and lead to a chronic (sometimes fatal) lung disease known as bronchopulmonary dysplasia. Avoiding this would mean figuring out a way to maintain fetal circulation – the intricate system that delivers oxygenated blood from the placenta to the fetus via the umbilical cord. Researchers at Children’s Hospital of Philadelphia have done this using a fetal lamb.
The key to their invention is a substitute placenta: an oxygenator connected to the lamb’s umbilical cord. Tubes inserted through the umbilical vein and arteries carry oxygenated blood from the “placenta” to the fetus, and deoxygenated blood back out. The lamb resides in an artificial, fluid-filled amniotic sac until its lungs and other organs are developed.
Fertility treatment could benefit, too. “An artificial womb may substitute in situations in which a gestational carrier – surrogate – is indicated,” says Paula Amato, MD, a professor of obstetrics and gynecology at Oregon Health and Science University, Portland. (Dr. Amato is not involved in the CHOP research.) For example: when the mother is missing a uterus or can’t carry a pregnancy safely.
No date is set for clinical trials yet. But according to the research, the main difference between human and lamb may come down to size. A lamb’s umbilical vessels are larger, so feeding in a tube is easier. With today’s advances in miniaturizing surgical methods, that seems like a challenge scientists can overcome.
Messenger RNA therapeutics
Back to “Star Trek.” The hypospray injector’s contents could cure just about any disease, even one newly discovered on a strange planet. That’s not unlike messenger RNA (mRNA) technology, a breakthrough that enabled scientists to quickly develop some of the first COVID-19 vaccines.
But vaccines are just the beginning of what this technology can do.
A whole field of immunotherapy is emerging that uses mRNA to deliver instructions to produce chimeric antigen receptor–modified immune cells (CAR-modified immune cells). These cells are engineered to target diseased cells and tissues, like cancer cells and harmful fibroblasts (scar tissue) that promote fibrosis in, for example, the heart and lungs.
The field is bursting with rodent research, and clinical trials have started for treating some advanced-stage malignancies.
Actual clinical use may be years away, but if all goes well, these medicines could help treat or even cure the core medical problems facing humanity. We’re talking cancer, heart disease, neurodegenerative disease – transforming one therapy into another by simply changing the mRNA’s “nucleotide sequence,” the blueprint containing instructions telling it what to do, and what disease to attack.
As this technology matures, we may start to feel as if we’re really on “Star Trek,” where Dr. Leonard “Bones” McCoy pulls out the same device to treat just about every disease or injury.
A version of this article first appeared on WebMD.com.
When I was a child, I watched syndicated episodes of the original “Star Trek.” I was dazzled by the space travel, sure, but also the medical technology.
A handheld “tricorder” detected diseases, while an intramuscular injector (“hypospray”) could treat them. Sickbay “biobeds” came with real-time health monitors that looked futuristic at the time but seem primitive today.
Such visions inspired a lot of us kids to pursue science. Little did we know the real-life advances many of us would see in our lifetimes.
Artificial intelligence helping to spot disease, robots performing surgery, even video calls between doctor and patient – all these once sounded fantastical but now happen in clinical care.
Now, in the 23rd year of the 21st century, you might not believe wht we’ll be capable of next. Three especially wild examples are moving closer to clinical reality.
Human hibernation
Captain America, Han Solo, and “Star Trek” villain Khan – all were preserved at low temperatures and then revived, waking up alive and well months, decades, or centuries later. These are fictional examples, to be sure, but the science they’re rooted in is real.
(In one extreme case, a climber survived after almost 9 hours of efforts to revive him.)
Useful for a space traveler? Maybe not. But it’s potentially huge for someone with life-threatening injuries from a car accident or a gunshot wound.
That’s the thinking behind a breakthrough procedure that came after decades of research on pigs and dogs, now in a clinical trial. The idea: A person with massive blood loss whose heart has stopped is injected with an ice-cold fluid, cooling them from the inside, down to about 50° F.
Doctors already induce more modest hypothermia to protect the brain and other organs after cardiac arrest and during surgery on the aortic arch (the main artery carrying blood from the heart).
But this experimental procedure – called emergency preservation and resuscitation (EPR) – goes far beyond that, dramatically “decreasing the body’s need for oxygen and blood flow,” says Samuel Tisherman, MD, a trauma surgeon at the University of Maryland Medical Center and the trial’s lead researcher. This puts the patient in a state of suspended animation that “could buy time for surgeons to stop the bleeding and save more of these patients.”
The technique has been done on at least six patients, though none were reported to survive. The trial is expected to include 20 people by the time it wraps up in December, according to the listing on the U.S. clinical trials database. Though given the strict requirements for candidates (emergency trauma victims who are not likely to survive), one can’t exactly rely on a set schedule.
Still, the technology is promising. Someday we may even use it to keep patients in suspended animation for months or years, experts predict, helping astronauts through decades-long spaceflights, or stalling death in sick patients awaiting a cure.
Artificial womb
Another sci-fi classic: growing human babies outside the womb. Think the fetus fields from “The Matrix,” or the frozen embryos in “Alien: Covenant.”
In 1923, British biologist J.B.S. Haldane coined a term for that – ectogenesis. He predicted that 70% of pregnancies would take place, from fertilization to birth, in artificial wombs by 2074. That many seems unlikely, but the timeline is on track.
Developing an embryo outside the womb is already routine in in vitro fertilization. And technology enables preterm babies to survive through much of the second half of gestation. Normal human pregnancy is 40 weeks, and the youngest preterm baby ever to survive was 21 weeks and 1 day old, just a few days younger than a smattering of others who lived.
The biggest obstacle for babies younger than that is lung viability. Mechanical ventilation can damage the lungs and lead to a chronic (sometimes fatal) lung disease known as bronchopulmonary dysplasia. Avoiding this would mean figuring out a way to maintain fetal circulation – the intricate system that delivers oxygenated blood from the placenta to the fetus via the umbilical cord. Researchers at Children’s Hospital of Philadelphia have done this using a fetal lamb.
The key to their invention is a substitute placenta: an oxygenator connected to the lamb’s umbilical cord. Tubes inserted through the umbilical vein and arteries carry oxygenated blood from the “placenta” to the fetus, and deoxygenated blood back out. The lamb resides in an artificial, fluid-filled amniotic sac until its lungs and other organs are developed.
Fertility treatment could benefit, too. “An artificial womb may substitute in situations in which a gestational carrier – surrogate – is indicated,” says Paula Amato, MD, a professor of obstetrics and gynecology at Oregon Health and Science University, Portland. (Dr. Amato is not involved in the CHOP research.) For example: when the mother is missing a uterus or can’t carry a pregnancy safely.
No date is set for clinical trials yet. But according to the research, the main difference between human and lamb may come down to size. A lamb’s umbilical vessels are larger, so feeding in a tube is easier. With today’s advances in miniaturizing surgical methods, that seems like a challenge scientists can overcome.
Messenger RNA therapeutics
Back to “Star Trek.” The hypospray injector’s contents could cure just about any disease, even one newly discovered on a strange planet. That’s not unlike messenger RNA (mRNA) technology, a breakthrough that enabled scientists to quickly develop some of the first COVID-19 vaccines.
But vaccines are just the beginning of what this technology can do.
A whole field of immunotherapy is emerging that uses mRNA to deliver instructions to produce chimeric antigen receptor–modified immune cells (CAR-modified immune cells). These cells are engineered to target diseased cells and tissues, like cancer cells and harmful fibroblasts (scar tissue) that promote fibrosis in, for example, the heart and lungs.
The field is bursting with rodent research, and clinical trials have started for treating some advanced-stage malignancies.
Actual clinical use may be years away, but if all goes well, these medicines could help treat or even cure the core medical problems facing humanity. We’re talking cancer, heart disease, neurodegenerative disease – transforming one therapy into another by simply changing the mRNA’s “nucleotide sequence,” the blueprint containing instructions telling it what to do, and what disease to attack.
As this technology matures, we may start to feel as if we’re really on “Star Trek,” where Dr. Leonard “Bones” McCoy pulls out the same device to treat just about every disease or injury.
A version of this article first appeared on WebMD.com.