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Meta‐analysis reveals effective prophylactic strategies for preeclampsia
Key clinical point: Low molecular weight heparin (LMWH), vitamin D supplementation, exercise, calcium supplementation, and aspirin reduce the risk for preeclampsia.
Major finding: LMWH (risk ratio [RR] 0.60; 95% CI 0.42-0.87), vitamin D supplementation (RR 0.65; 95% CI 0.45-0.95), exercise (RR 0.68; 95% CI 0.50-0.92), calcium supplementation (RR 0.71; 95% CI 0.62-0.82), and aspirin (RR 0.79; 95% CI 0.72-0.86) were the prophylactic strategies identified to significantly reduce the risk for preeclampsia.
Study details: Findings are from a network meta-analysis of 130 randomized controlled trials that involved 112,916 pregnant women at risk of developing preeclampsia, with preeclampsia being reported in 114 studies including 95,500 women.
Disclosures: This study was supported by the Shuangqing Talent Program Project of Guangdong Provincial People's Hospital, China, among others. The authors declared no conflicts of interest.
Source: Liu YH et al. Prophylactic strategies for preventing pre-eclampsia: A network meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2022 (Oct 22). Doi: 10.1016/j.ajog.2022.10.014
Key clinical point: Low molecular weight heparin (LMWH), vitamin D supplementation, exercise, calcium supplementation, and aspirin reduce the risk for preeclampsia.
Major finding: LMWH (risk ratio [RR] 0.60; 95% CI 0.42-0.87), vitamin D supplementation (RR 0.65; 95% CI 0.45-0.95), exercise (RR 0.68; 95% CI 0.50-0.92), calcium supplementation (RR 0.71; 95% CI 0.62-0.82), and aspirin (RR 0.79; 95% CI 0.72-0.86) were the prophylactic strategies identified to significantly reduce the risk for preeclampsia.
Study details: Findings are from a network meta-analysis of 130 randomized controlled trials that involved 112,916 pregnant women at risk of developing preeclampsia, with preeclampsia being reported in 114 studies including 95,500 women.
Disclosures: This study was supported by the Shuangqing Talent Program Project of Guangdong Provincial People's Hospital, China, among others. The authors declared no conflicts of interest.
Source: Liu YH et al. Prophylactic strategies for preventing pre-eclampsia: A network meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2022 (Oct 22). Doi: 10.1016/j.ajog.2022.10.014
Key clinical point: Low molecular weight heparin (LMWH), vitamin D supplementation, exercise, calcium supplementation, and aspirin reduce the risk for preeclampsia.
Major finding: LMWH (risk ratio [RR] 0.60; 95% CI 0.42-0.87), vitamin D supplementation (RR 0.65; 95% CI 0.45-0.95), exercise (RR 0.68; 95% CI 0.50-0.92), calcium supplementation (RR 0.71; 95% CI 0.62-0.82), and aspirin (RR 0.79; 95% CI 0.72-0.86) were the prophylactic strategies identified to significantly reduce the risk for preeclampsia.
Study details: Findings are from a network meta-analysis of 130 randomized controlled trials that involved 112,916 pregnant women at risk of developing preeclampsia, with preeclampsia being reported in 114 studies including 95,500 women.
Disclosures: This study was supported by the Shuangqing Talent Program Project of Guangdong Provincial People's Hospital, China, among others. The authors declared no conflicts of interest.
Source: Liu YH et al. Prophylactic strategies for preventing pre-eclampsia: A network meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2022 (Oct 22). Doi: 10.1016/j.ajog.2022.10.014
Women pursuing assisted reproductive technology prone to pregnancy-associated cardiovascular complications
Key clinical point: Compared with women who conceive naturally, those who conceive through assisted reproductive technology (ART) have a higher risk for cardiovascular complications, including preeclampsia/eclampsia, heart failure, and cardiac arrhythmias, during delivery admissions.
Major finding: Women who conceived through ART vs naturally had a higher risk for preeclampsia/eclampsia (adjusted odds ratio [aOR] 1.48; P < .01), heart failure (aOR 1.94; P < .01), and cardiac arrhythmias (aOR 1.39; P < .01).
Study details: This real-world population study analyzed the data of women hospitalized for deliveries (weighted n = 45,867,086), of which 108,542 had conceived through ART.
Disclosures: This study did not receive any specific funding. Some authors declared advisory board participation or consultancy for various organizations.
Source: Zahid S et al. Cardiovascular complications during delivery admissions associated with assisted reproductive technology (from a National Inpatient Sample analysis 2008 to 2019). Am J Cardiol. 2022 (Oct 23). Doi: 10.1016/j.amjcard.2022.08.037
Key clinical point: Compared with women who conceive naturally, those who conceive through assisted reproductive technology (ART) have a higher risk for cardiovascular complications, including preeclampsia/eclampsia, heart failure, and cardiac arrhythmias, during delivery admissions.
Major finding: Women who conceived through ART vs naturally had a higher risk for preeclampsia/eclampsia (adjusted odds ratio [aOR] 1.48; P < .01), heart failure (aOR 1.94; P < .01), and cardiac arrhythmias (aOR 1.39; P < .01).
Study details: This real-world population study analyzed the data of women hospitalized for deliveries (weighted n = 45,867,086), of which 108,542 had conceived through ART.
Disclosures: This study did not receive any specific funding. Some authors declared advisory board participation or consultancy for various organizations.
Source: Zahid S et al. Cardiovascular complications during delivery admissions associated with assisted reproductive technology (from a National Inpatient Sample analysis 2008 to 2019). Am J Cardiol. 2022 (Oct 23). Doi: 10.1016/j.amjcard.2022.08.037
Key clinical point: Compared with women who conceive naturally, those who conceive through assisted reproductive technology (ART) have a higher risk for cardiovascular complications, including preeclampsia/eclampsia, heart failure, and cardiac arrhythmias, during delivery admissions.
Major finding: Women who conceived through ART vs naturally had a higher risk for preeclampsia/eclampsia (adjusted odds ratio [aOR] 1.48; P < .01), heart failure (aOR 1.94; P < .01), and cardiac arrhythmias (aOR 1.39; P < .01).
Study details: This real-world population study analyzed the data of women hospitalized for deliveries (weighted n = 45,867,086), of which 108,542 had conceived through ART.
Disclosures: This study did not receive any specific funding. Some authors declared advisory board participation or consultancy for various organizations.
Source: Zahid S et al. Cardiovascular complications during delivery admissions associated with assisted reproductive technology (from a National Inpatient Sample analysis 2008 to 2019). Am J Cardiol. 2022 (Oct 23). Doi: 10.1016/j.amjcard.2022.08.037
Birth method affects microbiome and vaccination response
Babies born vaginally have a different microbiome to those born by Caesarean section and have heightened responses to childhood vaccinations, according to a new study heralded as “interesting and important” by experts.
The microbiome is known to play a role in immune responses to vaccination. However, the relationship between early-life effects on intestinal microbiota composition and subsequent childhood vaccine responses had remained poorly understood. In the new study, “the findings suggest that vaginal birthing resulted in a microbiota composition associated with an increase in a specific type of antibody response to two routine childhood vaccines in healthy babies, compared with Caesarean section,” the authors said.
Researchers from the University of Edinburgh, with colleagues at Spaarne Hospital and University Medical Centre in Utrecht, and the National Institute for Public Health and the Environment in The Netherlands, tracked the development of the gut microbiome in a cohort of 120 healthy, full-term infants and assessed their antibody levels following two common childhood vaccinations.
The study, published in Nature Communications, found “a clear relationship between microbes in the gut of those babies and levels of antibodies.” Not only was vaginal birth associated with increased levels of Bifidobacterium and Escherichia coli in the gut microbiome in the first months of life but also with higher IgG antibody responses against both pneumococcal and meningococcal vaccines.
Antibody responses doubled after vaginal birth
The babies were given pneumococcal and meningococcal vaccinations at 8 and 12 weeks, and saliva was collected at follow-up visits at ages 12 and 18 months for antibody measurement. In the 101 babies tested for pneumococcal antibodies, the researchers found that antibody levels were twice as high among babies delivered naturally, compared with those delivered by C-section. High levels of two gut bacteria in particular – Bifidobacterium and E. coli – were associated with high antibody responses to the pneumococcal vaccine, showing that the microbiome mediated the link between mode of delivery and pneumococcal vaccine responses.
In 66 babies tested for anti-meningococcal antibodies, antibodies were 1.7 times higher for vaginally-born babies than those delivered via C-section, and high antibody levels were particularly associated with high levels of E. coli in the babies’ microbiome.
The results were also influenced by breast-feeding, which even among children born vaginally was linked with 3.5 times higher pneumococcal antibody levels, compared with those of formula-fed children. In contrast, levels of antibodies against meningococcus were unaffected by breast-feeding status.
Microbiome ‘sets level of infection protection’
The team said: “The baby acquires Bifidobacterium and E. coli bacteria through natural birth, and human milk is needed to provide the sugars for these bacteria to thrive on.” They explained: “The gut microbiome is seeded at birth, developing rapidly over the first few months of life, and is influenced mostly by delivery mode, breast-feeding, and antibiotic use.” The babies’ microbiome in early life contributes the immune system’s response to vaccines, they said, “and sets the level of protection against certain infections in childhood.”
Study lead Professor Debby Bogaert, chair of pediatric medicine at the University of Edinburgh, said: “I think it is especially interesting that we identified several beneficial microbes to be the link between mode of delivery and vaccine responses. In the future, we may be able to supplement those bacteria to children born by C-section shortly after birth through – for example, mother-to-baby ‘fecal transplants’ or the use of specifically designed probiotics.”
First author Dr. Emma de Koff, a microbiology trainee at the Amsterdam University Medical Center, said: “We expected to find a link between the gut microbiome and the babies’ vaccine responses, however we never thought to find the strongest effects in the first weeks of life.”
The findings “could help to inform conversations about C-sections between expectant mothers and their doctors,” commented the researchers, who said that they could also “shape the design of more tailored vaccination programs.” For example, in the future, vaccination schedules could be adjusted based on the method of delivery or analysis of the baby’s microbiome.
Potential to rectify immune system after Caesarean
Responding to the study, Professor Neil Mabbott, personal chair in immunopathology at the Roslin Institute of the University of Edinburgh, told the Science Media Centre: “This is a very interesting and important study. The authors show that infants delivered by a vaginal birth had higher responses to the two different types of vaccines against bacterial diseases, and this was associated with higher abundances of the potentially beneficial bacteria known as Bifidobacterium and E. coli in their intestines.”
He added: “This study raises the possibility that it may be possible to treat infants, especially Caesarean-delivered infants, with a bacterial supplement, or even a product produced by these beneficial bacteria, to help improve their immune systems, enhance their responses to certain vaccines and reduce their susceptibility to infections.”
The study raises important questions, he said, including whether the increased antibody levels from pneumococcal and meningococcal vaccinations following vaginal birth also leads to increased protection of the infants against infection or serious disease.
Sheena Cruickshank, immunologist and professor in biomedical sciences at the University of Manchester, England, commented: “It is now well established that the microbiome is important in immune development. In turn the mode of delivery and initial method of feeding is important in how the microbiome is first seeded in the baby.”
“However, other factors such as exposure to antibiotics and subsequent diet also play a role in how it then develops, making understanding the way the microbiome develops and changes quite complex. Microbes works as communities, and it can be difficult to determine whether changes in single species are important functionally. Breast milk also plays an important role in protecting the baby via transfer of maternal immunoglobulins, which will wane over a period of 6-12 months in the baby – thus ascertaining whether it’s the baby’s Ig is challenging.
“Given the complexity of the multitude of interactions, it is important that this is accounted for, and group sizes are large enough to ensure data is robust. Whilst this is an interesting study that adds to our knowledge of how the microbiome develops and the possible implications for immune development, it is still very preliminary, and the small group sizes warrant a need for further studies to verify this in larger groups.”
She added: “We will need to understand whether possible impacts of maternal delivery and feeding on immune development or vaccine responses can be restored by, for example, manipulating the microbiome.”
Professor Kim Barrett, vice dean for research at the University of California, Davis School of Medicine, said that, while further research was needed to uncover if and how manipulation of the human microbiome following C-section births might improve vaccine efficacy, “the work should at least lead to prompt additional consideration about an unintended consequence of the ever-increasing use of C-sections that may not be medically-necessary.”
Dr. Marie Lewis, researcher in gut microbiota at the University of Reading, England, said: “We have known for quite some time that the mode of delivery is incredibly important when it comes to the type of bacteria which colonize our guts. We also know that our gut bacteria in early life drive the development of our immune system, and natural births are linked with reduced risks of developing inflammatory conditions, such as asthma. It is therefore perhaps not really surprising that mode of delivery is also linked to responses to vaccinations.”
“The really interesting part here is the extent to which our gut microbiotas are accessible and changeable, and this important work could pave the way for administration of probiotics and prebiotics to improve vaccine responses in Caesarean-born children.”
‘Tantalizing data’
Dr. Chrissie Jones, associate professor of pediatric infectious diseases at the University of Southampton, and Southampton UK and education lead for the British Paediatric Allergy, Immunity, and Infection Group, said: “The link between method of delivery of the infant and the bacteria that live in the gut of the young infant has previously been shown. What is really interesting about this study is that, for the first time, the link between method of delivery (vaginal delivery vs. C-section), differences in bacterial communities of the gut, and differences in responses to vaccines is shown.”
“This study may give us fresh insights into the differences that we see in the amount of protective antibodies made after infant vaccination. It also gives us clues as to ways that we might be able to level the playing field for infants in the future – for instance, giving babies a safe cocktail of ‘friendly bacteria’ as a probiotic, or an additional dose of vaccine.”
“This study is the first step – it shows us a link or association but does not prove cause and effect that differences in the way babies are born alters how the immune system responds to vaccines. To prove this link we will need larger studies, but it is tantalizing data.”
The research was funded by Scotland’s Chief Scientist Office and the Netherlands Organisation for Scientific Research. DB received funding from OM pharma and Sanofi. All of the authors declared no other conflicts of interest.
A version of this article first appeared on Medscape.com.
Babies born vaginally have a different microbiome to those born by Caesarean section and have heightened responses to childhood vaccinations, according to a new study heralded as “interesting and important” by experts.
The microbiome is known to play a role in immune responses to vaccination. However, the relationship between early-life effects on intestinal microbiota composition and subsequent childhood vaccine responses had remained poorly understood. In the new study, “the findings suggest that vaginal birthing resulted in a microbiota composition associated with an increase in a specific type of antibody response to two routine childhood vaccines in healthy babies, compared with Caesarean section,” the authors said.
Researchers from the University of Edinburgh, with colleagues at Spaarne Hospital and University Medical Centre in Utrecht, and the National Institute for Public Health and the Environment in The Netherlands, tracked the development of the gut microbiome in a cohort of 120 healthy, full-term infants and assessed their antibody levels following two common childhood vaccinations.
The study, published in Nature Communications, found “a clear relationship between microbes in the gut of those babies and levels of antibodies.” Not only was vaginal birth associated with increased levels of Bifidobacterium and Escherichia coli in the gut microbiome in the first months of life but also with higher IgG antibody responses against both pneumococcal and meningococcal vaccines.
Antibody responses doubled after vaginal birth
The babies were given pneumococcal and meningococcal vaccinations at 8 and 12 weeks, and saliva was collected at follow-up visits at ages 12 and 18 months for antibody measurement. In the 101 babies tested for pneumococcal antibodies, the researchers found that antibody levels were twice as high among babies delivered naturally, compared with those delivered by C-section. High levels of two gut bacteria in particular – Bifidobacterium and E. coli – were associated with high antibody responses to the pneumococcal vaccine, showing that the microbiome mediated the link between mode of delivery and pneumococcal vaccine responses.
In 66 babies tested for anti-meningococcal antibodies, antibodies were 1.7 times higher for vaginally-born babies than those delivered via C-section, and high antibody levels were particularly associated with high levels of E. coli in the babies’ microbiome.
The results were also influenced by breast-feeding, which even among children born vaginally was linked with 3.5 times higher pneumococcal antibody levels, compared with those of formula-fed children. In contrast, levels of antibodies against meningococcus were unaffected by breast-feeding status.
Microbiome ‘sets level of infection protection’
The team said: “The baby acquires Bifidobacterium and E. coli bacteria through natural birth, and human milk is needed to provide the sugars for these bacteria to thrive on.” They explained: “The gut microbiome is seeded at birth, developing rapidly over the first few months of life, and is influenced mostly by delivery mode, breast-feeding, and antibiotic use.” The babies’ microbiome in early life contributes the immune system’s response to vaccines, they said, “and sets the level of protection against certain infections in childhood.”
Study lead Professor Debby Bogaert, chair of pediatric medicine at the University of Edinburgh, said: “I think it is especially interesting that we identified several beneficial microbes to be the link between mode of delivery and vaccine responses. In the future, we may be able to supplement those bacteria to children born by C-section shortly after birth through – for example, mother-to-baby ‘fecal transplants’ or the use of specifically designed probiotics.”
First author Dr. Emma de Koff, a microbiology trainee at the Amsterdam University Medical Center, said: “We expected to find a link between the gut microbiome and the babies’ vaccine responses, however we never thought to find the strongest effects in the first weeks of life.”
The findings “could help to inform conversations about C-sections between expectant mothers and their doctors,” commented the researchers, who said that they could also “shape the design of more tailored vaccination programs.” For example, in the future, vaccination schedules could be adjusted based on the method of delivery or analysis of the baby’s microbiome.
Potential to rectify immune system after Caesarean
Responding to the study, Professor Neil Mabbott, personal chair in immunopathology at the Roslin Institute of the University of Edinburgh, told the Science Media Centre: “This is a very interesting and important study. The authors show that infants delivered by a vaginal birth had higher responses to the two different types of vaccines against bacterial diseases, and this was associated with higher abundances of the potentially beneficial bacteria known as Bifidobacterium and E. coli in their intestines.”
He added: “This study raises the possibility that it may be possible to treat infants, especially Caesarean-delivered infants, with a bacterial supplement, or even a product produced by these beneficial bacteria, to help improve their immune systems, enhance their responses to certain vaccines and reduce their susceptibility to infections.”
The study raises important questions, he said, including whether the increased antibody levels from pneumococcal and meningococcal vaccinations following vaginal birth also leads to increased protection of the infants against infection or serious disease.
Sheena Cruickshank, immunologist and professor in biomedical sciences at the University of Manchester, England, commented: “It is now well established that the microbiome is important in immune development. In turn the mode of delivery and initial method of feeding is important in how the microbiome is first seeded in the baby.”
“However, other factors such as exposure to antibiotics and subsequent diet also play a role in how it then develops, making understanding the way the microbiome develops and changes quite complex. Microbes works as communities, and it can be difficult to determine whether changes in single species are important functionally. Breast milk also plays an important role in protecting the baby via transfer of maternal immunoglobulins, which will wane over a period of 6-12 months in the baby – thus ascertaining whether it’s the baby’s Ig is challenging.
“Given the complexity of the multitude of interactions, it is important that this is accounted for, and group sizes are large enough to ensure data is robust. Whilst this is an interesting study that adds to our knowledge of how the microbiome develops and the possible implications for immune development, it is still very preliminary, and the small group sizes warrant a need for further studies to verify this in larger groups.”
She added: “We will need to understand whether possible impacts of maternal delivery and feeding on immune development or vaccine responses can be restored by, for example, manipulating the microbiome.”
Professor Kim Barrett, vice dean for research at the University of California, Davis School of Medicine, said that, while further research was needed to uncover if and how manipulation of the human microbiome following C-section births might improve vaccine efficacy, “the work should at least lead to prompt additional consideration about an unintended consequence of the ever-increasing use of C-sections that may not be medically-necessary.”
Dr. Marie Lewis, researcher in gut microbiota at the University of Reading, England, said: “We have known for quite some time that the mode of delivery is incredibly important when it comes to the type of bacteria which colonize our guts. We also know that our gut bacteria in early life drive the development of our immune system, and natural births are linked with reduced risks of developing inflammatory conditions, such as asthma. It is therefore perhaps not really surprising that mode of delivery is also linked to responses to vaccinations.”
“The really interesting part here is the extent to which our gut microbiotas are accessible and changeable, and this important work could pave the way for administration of probiotics and prebiotics to improve vaccine responses in Caesarean-born children.”
‘Tantalizing data’
Dr. Chrissie Jones, associate professor of pediatric infectious diseases at the University of Southampton, and Southampton UK and education lead for the British Paediatric Allergy, Immunity, and Infection Group, said: “The link between method of delivery of the infant and the bacteria that live in the gut of the young infant has previously been shown. What is really interesting about this study is that, for the first time, the link between method of delivery (vaginal delivery vs. C-section), differences in bacterial communities of the gut, and differences in responses to vaccines is shown.”
“This study may give us fresh insights into the differences that we see in the amount of protective antibodies made after infant vaccination. It also gives us clues as to ways that we might be able to level the playing field for infants in the future – for instance, giving babies a safe cocktail of ‘friendly bacteria’ as a probiotic, or an additional dose of vaccine.”
“This study is the first step – it shows us a link or association but does not prove cause and effect that differences in the way babies are born alters how the immune system responds to vaccines. To prove this link we will need larger studies, but it is tantalizing data.”
The research was funded by Scotland’s Chief Scientist Office and the Netherlands Organisation for Scientific Research. DB received funding from OM pharma and Sanofi. All of the authors declared no other conflicts of interest.
A version of this article first appeared on Medscape.com.
Babies born vaginally have a different microbiome to those born by Caesarean section and have heightened responses to childhood vaccinations, according to a new study heralded as “interesting and important” by experts.
The microbiome is known to play a role in immune responses to vaccination. However, the relationship between early-life effects on intestinal microbiota composition and subsequent childhood vaccine responses had remained poorly understood. In the new study, “the findings suggest that vaginal birthing resulted in a microbiota composition associated with an increase in a specific type of antibody response to two routine childhood vaccines in healthy babies, compared with Caesarean section,” the authors said.
Researchers from the University of Edinburgh, with colleagues at Spaarne Hospital and University Medical Centre in Utrecht, and the National Institute for Public Health and the Environment in The Netherlands, tracked the development of the gut microbiome in a cohort of 120 healthy, full-term infants and assessed their antibody levels following two common childhood vaccinations.
The study, published in Nature Communications, found “a clear relationship between microbes in the gut of those babies and levels of antibodies.” Not only was vaginal birth associated with increased levels of Bifidobacterium and Escherichia coli in the gut microbiome in the first months of life but also with higher IgG antibody responses against both pneumococcal and meningococcal vaccines.
Antibody responses doubled after vaginal birth
The babies were given pneumococcal and meningococcal vaccinations at 8 and 12 weeks, and saliva was collected at follow-up visits at ages 12 and 18 months for antibody measurement. In the 101 babies tested for pneumococcal antibodies, the researchers found that antibody levels were twice as high among babies delivered naturally, compared with those delivered by C-section. High levels of two gut bacteria in particular – Bifidobacterium and E. coli – were associated with high antibody responses to the pneumococcal vaccine, showing that the microbiome mediated the link between mode of delivery and pneumococcal vaccine responses.
In 66 babies tested for anti-meningococcal antibodies, antibodies were 1.7 times higher for vaginally-born babies than those delivered via C-section, and high antibody levels were particularly associated with high levels of E. coli in the babies’ microbiome.
The results were also influenced by breast-feeding, which even among children born vaginally was linked with 3.5 times higher pneumococcal antibody levels, compared with those of formula-fed children. In contrast, levels of antibodies against meningococcus were unaffected by breast-feeding status.
Microbiome ‘sets level of infection protection’
The team said: “The baby acquires Bifidobacterium and E. coli bacteria through natural birth, and human milk is needed to provide the sugars for these bacteria to thrive on.” They explained: “The gut microbiome is seeded at birth, developing rapidly over the first few months of life, and is influenced mostly by delivery mode, breast-feeding, and antibiotic use.” The babies’ microbiome in early life contributes the immune system’s response to vaccines, they said, “and sets the level of protection against certain infections in childhood.”
Study lead Professor Debby Bogaert, chair of pediatric medicine at the University of Edinburgh, said: “I think it is especially interesting that we identified several beneficial microbes to be the link between mode of delivery and vaccine responses. In the future, we may be able to supplement those bacteria to children born by C-section shortly after birth through – for example, mother-to-baby ‘fecal transplants’ or the use of specifically designed probiotics.”
First author Dr. Emma de Koff, a microbiology trainee at the Amsterdam University Medical Center, said: “We expected to find a link between the gut microbiome and the babies’ vaccine responses, however we never thought to find the strongest effects in the first weeks of life.”
The findings “could help to inform conversations about C-sections between expectant mothers and their doctors,” commented the researchers, who said that they could also “shape the design of more tailored vaccination programs.” For example, in the future, vaccination schedules could be adjusted based on the method of delivery or analysis of the baby’s microbiome.
Potential to rectify immune system after Caesarean
Responding to the study, Professor Neil Mabbott, personal chair in immunopathology at the Roslin Institute of the University of Edinburgh, told the Science Media Centre: “This is a very interesting and important study. The authors show that infants delivered by a vaginal birth had higher responses to the two different types of vaccines against bacterial diseases, and this was associated with higher abundances of the potentially beneficial bacteria known as Bifidobacterium and E. coli in their intestines.”
He added: “This study raises the possibility that it may be possible to treat infants, especially Caesarean-delivered infants, with a bacterial supplement, or even a product produced by these beneficial bacteria, to help improve their immune systems, enhance their responses to certain vaccines and reduce their susceptibility to infections.”
The study raises important questions, he said, including whether the increased antibody levels from pneumococcal and meningococcal vaccinations following vaginal birth also leads to increased protection of the infants against infection or serious disease.
Sheena Cruickshank, immunologist and professor in biomedical sciences at the University of Manchester, England, commented: “It is now well established that the microbiome is important in immune development. In turn the mode of delivery and initial method of feeding is important in how the microbiome is first seeded in the baby.”
“However, other factors such as exposure to antibiotics and subsequent diet also play a role in how it then develops, making understanding the way the microbiome develops and changes quite complex. Microbes works as communities, and it can be difficult to determine whether changes in single species are important functionally. Breast milk also plays an important role in protecting the baby via transfer of maternal immunoglobulins, which will wane over a period of 6-12 months in the baby – thus ascertaining whether it’s the baby’s Ig is challenging.
“Given the complexity of the multitude of interactions, it is important that this is accounted for, and group sizes are large enough to ensure data is robust. Whilst this is an interesting study that adds to our knowledge of how the microbiome develops and the possible implications for immune development, it is still very preliminary, and the small group sizes warrant a need for further studies to verify this in larger groups.”
She added: “We will need to understand whether possible impacts of maternal delivery and feeding on immune development or vaccine responses can be restored by, for example, manipulating the microbiome.”
Professor Kim Barrett, vice dean for research at the University of California, Davis School of Medicine, said that, while further research was needed to uncover if and how manipulation of the human microbiome following C-section births might improve vaccine efficacy, “the work should at least lead to prompt additional consideration about an unintended consequence of the ever-increasing use of C-sections that may not be medically-necessary.”
Dr. Marie Lewis, researcher in gut microbiota at the University of Reading, England, said: “We have known for quite some time that the mode of delivery is incredibly important when it comes to the type of bacteria which colonize our guts. We also know that our gut bacteria in early life drive the development of our immune system, and natural births are linked with reduced risks of developing inflammatory conditions, such as asthma. It is therefore perhaps not really surprising that mode of delivery is also linked to responses to vaccinations.”
“The really interesting part here is the extent to which our gut microbiotas are accessible and changeable, and this important work could pave the way for administration of probiotics and prebiotics to improve vaccine responses in Caesarean-born children.”
‘Tantalizing data’
Dr. Chrissie Jones, associate professor of pediatric infectious diseases at the University of Southampton, and Southampton UK and education lead for the British Paediatric Allergy, Immunity, and Infection Group, said: “The link between method of delivery of the infant and the bacteria that live in the gut of the young infant has previously been shown. What is really interesting about this study is that, for the first time, the link between method of delivery (vaginal delivery vs. C-section), differences in bacterial communities of the gut, and differences in responses to vaccines is shown.”
“This study may give us fresh insights into the differences that we see in the amount of protective antibodies made after infant vaccination. It also gives us clues as to ways that we might be able to level the playing field for infants in the future – for instance, giving babies a safe cocktail of ‘friendly bacteria’ as a probiotic, or an additional dose of vaccine.”
“This study is the first step – it shows us a link or association but does not prove cause and effect that differences in the way babies are born alters how the immune system responds to vaccines. To prove this link we will need larger studies, but it is tantalizing data.”
The research was funded by Scotland’s Chief Scientist Office and the Netherlands Organisation for Scientific Research. DB received funding from OM pharma and Sanofi. All of the authors declared no other conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM NATURE COMMUNICATIONS
Postpartum posttraumatic stress disorder: An underestimated reality?
PAU, FRANCE – Postpartum posttraumatic stress disorder tends to get worse over the months following the birth of a child. Therefore, it’s necessary to screen for it as early on as possible and to ensure that women who are affected are given the proper treatment. This was the message delivered during the Infogyn 2022 conference by Ludivine Franchitto, MD, a child psychiatrist at Toulouse University Hospital, France. Because postpartum PTSD is still not fully recognized, treatment remains inadequate and poorly documented.
Impact on the caregivers as well
“The situation is the same as what we saw with postpartum depression. The debate went on for 20 years before its existence was formally declared,” Dr. Franchitto noted. But for her, the important thing is not knowing whether a traumatic stress state may be experienced by the mother who had complications during pregnancy or delivery. Instead, it’s about focusing on the repercussions for the child.
During her presentation, Dr. Franchitto also pointed out that it’s necessary to recognize that caregivers who work in maternity wards may also be negatively impacted, as they routinely see the complications that women have during pregnancy and delivery. These workers may also develop a PTSD state, requiring support so that they can properly carry out their duties.
According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), posttraumatic stress disorder arises after exposure to actual (or threatened) death, serious injury, or sexual violence. Individuals who have witnessed a traumatic event in person or who have experienced repeated (or extreme) exposure to aversive details of traumatic events may also develop PTSD.
Dr. Franchitto mentioned some of the criteria needed to make the diagnosis. “Intrusive distressing memories of the event, recurrent distressing dreams related to the event, persistent avoidance of stimuli associated with the traumatic event, or negative alterations in cognitions and mood associated with the traumatic event. And the duration of the disturbance is more than 1 month.” There may also be marked alterations in arousal and reactivity associated with the traumatic event (for example, irritable behavior, loss of awareness of present surroundings).
Prevalent in 18% of women in high-risk groups
According to the studies, there is a wide variability of PTSD rates. If referring only to traumatic symptoms (for example, depressive syndrome, suicidal ideation, hyperreactivity, and persistent avoidance), the rate could reach up to 40%. A 2016 meta-analysis of 59 studies found that the prevalence of childbirth-related PTSD was 5.9%.
The authors distinguished two groups of women: those without complications during pregnancy or during delivery and those with severe complications related to the pregnancy, a fear of giving birth, a difficult delivery, an emergency C-section, a baby born prematurely with birth defects, etc. Their analysis showed PTSD rates of 4% and 18.5%, respectively.
Surprisingly, the major risk factor for PTSD turned out to be uncontrollable vomiting during pregnancy (seen in 40% of postpartum PTSD cases). The birth of a baby with birth defects was the second risk factor (35%), and the third, a history of violence in the mother’s childhood (34%). Women who experienced depression during the delivery were also at higher risk.
Other risk factors identified were lack of communication with the health care team, lack of consent, lack of support from the medical staff, and a long labor. Conversely, a sense of control and the support of a partner play a protective role.
Early screening
“If the symptoms of posttraumatic stress disorder aren’t treated after delivery, they tend to get worse over the period of 1 to 6 months following the child’s birth,” Dr. Franchitto indicated. This is why it’s necessary to screen for it as early as possible – in particular, by having the women fill out the City Birth Trauma Scale questionnaire – and provide proper treatment accordingly. When seeking to limit the effects of stress, early intervention by a psychologist may be beneficial.
Psychotherapy is the recommended first-line treatment for PTSD, especially cognitive behavioral therapy and Eye Movement Desensitization and Reprocessing therapy. This approach aims to limit the mental and behavioral avoidance that prevents the traumatic memory from being integrated and processed as a regular memory.
The consequences that the mother’s PTSD state has on the child are well documented. “Children whose mothers had PTSD during pregnancy have a lower birth weight and a shorter breast-feeding duration,” Dr. Franchitto reported. With respect to the quality of the mother-child relationship and the long-term development of the child, “the studies have highly conflicting findings.”
At the end of the presentation, Professor Israël Nisand, MD, an ob.gyn. at the American Hospital of Paris and the former president of the National College of French Gynecologists and Obstetricians, made the following comment: “I often think that we underestimate the consequences that the mother’s posttraumatic stress has on the child postpartum.” He added, “Postpartum posttraumatic stress disorder is a reality. Yet it isn’t screened for, let alone treated, even though it has serious consequences for the child.”
Dr. Franchitto also brought up the impact on members of the health care staff, the “second victims” of the traumatic events that occur while caring for the women in the maternity ward. “The estimated prevalence of PTSD symptoms among midwives is 22.9%,” which could lead to “a loss of confidence and a desire to leave the profession.”
Providing psychoeducation to health care staff
Dr. Franchitto believes that it’s essential to also protect caregivers who work in maternity wards. “It’s important to have the support of colleagues” – in particular, of team leaders – “and to share one’s experiences,” as long as one knows how to recognize the symptoms of posttraumatic stress through one’s emotions and is able to verbalize them.
She went on to say that providing psychoeducation to health care staff is therefore to be encouraged, as is “simulation-based training, for learning how to manage problematic situations.”
This content was originally published on Medscape French edition. A translated version appeared on Medscape.com.
PAU, FRANCE – Postpartum posttraumatic stress disorder tends to get worse over the months following the birth of a child. Therefore, it’s necessary to screen for it as early on as possible and to ensure that women who are affected are given the proper treatment. This was the message delivered during the Infogyn 2022 conference by Ludivine Franchitto, MD, a child psychiatrist at Toulouse University Hospital, France. Because postpartum PTSD is still not fully recognized, treatment remains inadequate and poorly documented.
Impact on the caregivers as well
“The situation is the same as what we saw with postpartum depression. The debate went on for 20 years before its existence was formally declared,” Dr. Franchitto noted. But for her, the important thing is not knowing whether a traumatic stress state may be experienced by the mother who had complications during pregnancy or delivery. Instead, it’s about focusing on the repercussions for the child.
During her presentation, Dr. Franchitto also pointed out that it’s necessary to recognize that caregivers who work in maternity wards may also be negatively impacted, as they routinely see the complications that women have during pregnancy and delivery. These workers may also develop a PTSD state, requiring support so that they can properly carry out their duties.
According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), posttraumatic stress disorder arises after exposure to actual (or threatened) death, serious injury, or sexual violence. Individuals who have witnessed a traumatic event in person or who have experienced repeated (or extreme) exposure to aversive details of traumatic events may also develop PTSD.
Dr. Franchitto mentioned some of the criteria needed to make the diagnosis. “Intrusive distressing memories of the event, recurrent distressing dreams related to the event, persistent avoidance of stimuli associated with the traumatic event, or negative alterations in cognitions and mood associated with the traumatic event. And the duration of the disturbance is more than 1 month.” There may also be marked alterations in arousal and reactivity associated with the traumatic event (for example, irritable behavior, loss of awareness of present surroundings).
Prevalent in 18% of women in high-risk groups
According to the studies, there is a wide variability of PTSD rates. If referring only to traumatic symptoms (for example, depressive syndrome, suicidal ideation, hyperreactivity, and persistent avoidance), the rate could reach up to 40%. A 2016 meta-analysis of 59 studies found that the prevalence of childbirth-related PTSD was 5.9%.
The authors distinguished two groups of women: those without complications during pregnancy or during delivery and those with severe complications related to the pregnancy, a fear of giving birth, a difficult delivery, an emergency C-section, a baby born prematurely with birth defects, etc. Their analysis showed PTSD rates of 4% and 18.5%, respectively.
Surprisingly, the major risk factor for PTSD turned out to be uncontrollable vomiting during pregnancy (seen in 40% of postpartum PTSD cases). The birth of a baby with birth defects was the second risk factor (35%), and the third, a history of violence in the mother’s childhood (34%). Women who experienced depression during the delivery were also at higher risk.
Other risk factors identified were lack of communication with the health care team, lack of consent, lack of support from the medical staff, and a long labor. Conversely, a sense of control and the support of a partner play a protective role.
Early screening
“If the symptoms of posttraumatic stress disorder aren’t treated after delivery, they tend to get worse over the period of 1 to 6 months following the child’s birth,” Dr. Franchitto indicated. This is why it’s necessary to screen for it as early as possible – in particular, by having the women fill out the City Birth Trauma Scale questionnaire – and provide proper treatment accordingly. When seeking to limit the effects of stress, early intervention by a psychologist may be beneficial.
Psychotherapy is the recommended first-line treatment for PTSD, especially cognitive behavioral therapy and Eye Movement Desensitization and Reprocessing therapy. This approach aims to limit the mental and behavioral avoidance that prevents the traumatic memory from being integrated and processed as a regular memory.
The consequences that the mother’s PTSD state has on the child are well documented. “Children whose mothers had PTSD during pregnancy have a lower birth weight and a shorter breast-feeding duration,” Dr. Franchitto reported. With respect to the quality of the mother-child relationship and the long-term development of the child, “the studies have highly conflicting findings.”
At the end of the presentation, Professor Israël Nisand, MD, an ob.gyn. at the American Hospital of Paris and the former president of the National College of French Gynecologists and Obstetricians, made the following comment: “I often think that we underestimate the consequences that the mother’s posttraumatic stress has on the child postpartum.” He added, “Postpartum posttraumatic stress disorder is a reality. Yet it isn’t screened for, let alone treated, even though it has serious consequences for the child.”
Dr. Franchitto also brought up the impact on members of the health care staff, the “second victims” of the traumatic events that occur while caring for the women in the maternity ward. “The estimated prevalence of PTSD symptoms among midwives is 22.9%,” which could lead to “a loss of confidence and a desire to leave the profession.”
Providing psychoeducation to health care staff
Dr. Franchitto believes that it’s essential to also protect caregivers who work in maternity wards. “It’s important to have the support of colleagues” – in particular, of team leaders – “and to share one’s experiences,” as long as one knows how to recognize the symptoms of posttraumatic stress through one’s emotions and is able to verbalize them.
She went on to say that providing psychoeducation to health care staff is therefore to be encouraged, as is “simulation-based training, for learning how to manage problematic situations.”
This content was originally published on Medscape French edition. A translated version appeared on Medscape.com.
PAU, FRANCE – Postpartum posttraumatic stress disorder tends to get worse over the months following the birth of a child. Therefore, it’s necessary to screen for it as early on as possible and to ensure that women who are affected are given the proper treatment. This was the message delivered during the Infogyn 2022 conference by Ludivine Franchitto, MD, a child psychiatrist at Toulouse University Hospital, France. Because postpartum PTSD is still not fully recognized, treatment remains inadequate and poorly documented.
Impact on the caregivers as well
“The situation is the same as what we saw with postpartum depression. The debate went on for 20 years before its existence was formally declared,” Dr. Franchitto noted. But for her, the important thing is not knowing whether a traumatic stress state may be experienced by the mother who had complications during pregnancy or delivery. Instead, it’s about focusing on the repercussions for the child.
During her presentation, Dr. Franchitto also pointed out that it’s necessary to recognize that caregivers who work in maternity wards may also be negatively impacted, as they routinely see the complications that women have during pregnancy and delivery. These workers may also develop a PTSD state, requiring support so that they can properly carry out their duties.
According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), posttraumatic stress disorder arises after exposure to actual (or threatened) death, serious injury, or sexual violence. Individuals who have witnessed a traumatic event in person or who have experienced repeated (or extreme) exposure to aversive details of traumatic events may also develop PTSD.
Dr. Franchitto mentioned some of the criteria needed to make the diagnosis. “Intrusive distressing memories of the event, recurrent distressing dreams related to the event, persistent avoidance of stimuli associated with the traumatic event, or negative alterations in cognitions and mood associated with the traumatic event. And the duration of the disturbance is more than 1 month.” There may also be marked alterations in arousal and reactivity associated with the traumatic event (for example, irritable behavior, loss of awareness of present surroundings).
Prevalent in 18% of women in high-risk groups
According to the studies, there is a wide variability of PTSD rates. If referring only to traumatic symptoms (for example, depressive syndrome, suicidal ideation, hyperreactivity, and persistent avoidance), the rate could reach up to 40%. A 2016 meta-analysis of 59 studies found that the prevalence of childbirth-related PTSD was 5.9%.
The authors distinguished two groups of women: those without complications during pregnancy or during delivery and those with severe complications related to the pregnancy, a fear of giving birth, a difficult delivery, an emergency C-section, a baby born prematurely with birth defects, etc. Their analysis showed PTSD rates of 4% and 18.5%, respectively.
Surprisingly, the major risk factor for PTSD turned out to be uncontrollable vomiting during pregnancy (seen in 40% of postpartum PTSD cases). The birth of a baby with birth defects was the second risk factor (35%), and the third, a history of violence in the mother’s childhood (34%). Women who experienced depression during the delivery were also at higher risk.
Other risk factors identified were lack of communication with the health care team, lack of consent, lack of support from the medical staff, and a long labor. Conversely, a sense of control and the support of a partner play a protective role.
Early screening
“If the symptoms of posttraumatic stress disorder aren’t treated after delivery, they tend to get worse over the period of 1 to 6 months following the child’s birth,” Dr. Franchitto indicated. This is why it’s necessary to screen for it as early as possible – in particular, by having the women fill out the City Birth Trauma Scale questionnaire – and provide proper treatment accordingly. When seeking to limit the effects of stress, early intervention by a psychologist may be beneficial.
Psychotherapy is the recommended first-line treatment for PTSD, especially cognitive behavioral therapy and Eye Movement Desensitization and Reprocessing therapy. This approach aims to limit the mental and behavioral avoidance that prevents the traumatic memory from being integrated and processed as a regular memory.
The consequences that the mother’s PTSD state has on the child are well documented. “Children whose mothers had PTSD during pregnancy have a lower birth weight and a shorter breast-feeding duration,” Dr. Franchitto reported. With respect to the quality of the mother-child relationship and the long-term development of the child, “the studies have highly conflicting findings.”
At the end of the presentation, Professor Israël Nisand, MD, an ob.gyn. at the American Hospital of Paris and the former president of the National College of French Gynecologists and Obstetricians, made the following comment: “I often think that we underestimate the consequences that the mother’s posttraumatic stress has on the child postpartum.” He added, “Postpartum posttraumatic stress disorder is a reality. Yet it isn’t screened for, let alone treated, even though it has serious consequences for the child.”
Dr. Franchitto also brought up the impact on members of the health care staff, the “second victims” of the traumatic events that occur while caring for the women in the maternity ward. “The estimated prevalence of PTSD symptoms among midwives is 22.9%,” which could lead to “a loss of confidence and a desire to leave the profession.”
Providing psychoeducation to health care staff
Dr. Franchitto believes that it’s essential to also protect caregivers who work in maternity wards. “It’s important to have the support of colleagues” – in particular, of team leaders – “and to share one’s experiences,” as long as one knows how to recognize the symptoms of posttraumatic stress through one’s emotions and is able to verbalize them.
She went on to say that providing psychoeducation to health care staff is therefore to be encouraged, as is “simulation-based training, for learning how to manage problematic situations.”
This content was originally published on Medscape French edition. A translated version appeared on Medscape.com.
NSAIDs for spondyloarthritis may affect time to conception
PHILADELPHIA – Women with spondyloarthritis (SpA) who are desiring pregnancy may want to consider decreasing use or discontinuing use (with supervision) of nonsteroidal anti-inflammatory drugs before conception, new data suggest.
Researchers have found a connection between NSAID use and age and a significantly longer time to conception among women with spondyloarthritis. Sabrina Hamroun, MMed, with the rheumatology department at the University Hospital Cochin, Paris, presented the findings during a press conference at the annual meeting of the American College of Rheumatology.
SpA commonly affects women of childbearing age, but data are sparse regarding the effects of disease on fertility.
Patients in the study were taken from the French multicenter cohort GR2 from 2015 to June 2021.
Among the 207 patients with SpA in the cohort, 88 were selected for analysis of time to conception. Of these, 56 patients (63.6%) had a clinical pregnancy during follow-up.
Subfertility group took an average of 16 months to get pregnant
Subfertility was observed in 40 (45.4%) of the women, with an average time to conception of 16.1 months. A woman was considered subfertile if her time to conception was more than 12 months or if she did not become pregnant.
The average preconception Bath Ankylosing Spondylitis Disease Activity Index score was 2.9 (+/- 2.1), the authors noted. The average age of the participants was 32 years.
Twenty-three patients were treated with NSAIDs, eight with corticosteroids, 12 with conventional synthetic disease-modifying antirheumatic drugs, and 61 with biologics.
Researchers adjusted for factors including age, body mass index, disease duration and severity, smoking, form of SpA (axial, peripheral, or both), and medication in the preconception period.
They found significant associations between longer time to conception and age (hazard ratio, 1.22; 95% confidence interval, 1.08-1.40; P < .001), and a much higher hazard ratio with the use of NSAIDs during preconception (HR, 3.01; 95% CI, 2.15-3.85; P = .01).
Some data unavailable
Ms. Hamroun acknowledged that no data were available on the frequency of sexual intercourse or quality of life, factors that could affect time to conception. Women were asked when they discontinued contraceptive use and actively began trying to become pregnant.
She stated that information on the dose of NSAIDs used by the patients was incomplete, noting, “We were therefore unable to adjust the results of our statistical analyses on the dose used by patients.”
Additionally, because the study participants were patients at tertiary centers in France and had more severe disease, the results may not be generalizable to all women of childbearing age. Patients with less severe SpA are often managed in outpatient settings in France, she said.
When asked about alternatives to NSAIDs, Ms. Hamroun said that anti–tumor necrosis factor agents with low placental passage may be a good alternative “if a woman with long-standing difficulties to conceive needs a regular use of NSAIDs to control disease activity, in the absence of any other cause of subfertility.”
The patient’s age must also be considered, she noted.
“A therapeutic switch may be favored in a woman over 35 years of age, for example, whose fertility is already impaired by age,” Ms. Hamroun said.
As for the mechanism that might explain the effects of NSAIDs on conception, Ms. Hamroun said that prostaglandins are essential to ovulation and embryo implantation and explained that NSAIDs may work against ovulation and result in poor implantation (miscarriage) by blocking prostaglandins.
She pointed out that her results are in line with the ACR’s recommendation to discontinue NSAID use during the preconception period in women with SpA who are having difficulty conceiving.
Control before conception is important
Sinead Maguire, MD, a clinical and research fellow in the Spondylitis Program at Toronto (Ont.) Western Hospital who was not part of the study, said the study highlights the importance of optimizing disease control before conception.
“There are a number of things rheumatologists can do to support our SpA patients when they are trying to conceive,” she told this news organization. “One of the most important issues to address is ensuring their SpA is in remission and continues to remain so. For that reason, if a woman is requiring regular NSAIDs for symptom control, the results of this study might encourage me to consider a biologic agent sooner to ensure remission.”
She urged women who want to become pregnant to discuss medications with their rheumatologist before trying to conceive.
“It is very exciting to see studies such as this so that rheumatologists can provide answers to our patients’ questions with evidence-based advice,” she said.
Ms. Hamroun and several coauthors had no disclosures. Other coauthors disclosed relationships with companies including Merck/MSD, Novartis, Janssen, AbbVie/Abbott, Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, Galapagos, Eli Lilly, Novartis, and/or UCB. Dr. Maguire reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
PHILADELPHIA – Women with spondyloarthritis (SpA) who are desiring pregnancy may want to consider decreasing use or discontinuing use (with supervision) of nonsteroidal anti-inflammatory drugs before conception, new data suggest.
Researchers have found a connection between NSAID use and age and a significantly longer time to conception among women with spondyloarthritis. Sabrina Hamroun, MMed, with the rheumatology department at the University Hospital Cochin, Paris, presented the findings during a press conference at the annual meeting of the American College of Rheumatology.
SpA commonly affects women of childbearing age, but data are sparse regarding the effects of disease on fertility.
Patients in the study were taken from the French multicenter cohort GR2 from 2015 to June 2021.
Among the 207 patients with SpA in the cohort, 88 were selected for analysis of time to conception. Of these, 56 patients (63.6%) had a clinical pregnancy during follow-up.
Subfertility group took an average of 16 months to get pregnant
Subfertility was observed in 40 (45.4%) of the women, with an average time to conception of 16.1 months. A woman was considered subfertile if her time to conception was more than 12 months or if she did not become pregnant.
The average preconception Bath Ankylosing Spondylitis Disease Activity Index score was 2.9 (+/- 2.1), the authors noted. The average age of the participants was 32 years.
Twenty-three patients were treated with NSAIDs, eight with corticosteroids, 12 with conventional synthetic disease-modifying antirheumatic drugs, and 61 with biologics.
Researchers adjusted for factors including age, body mass index, disease duration and severity, smoking, form of SpA (axial, peripheral, or both), and medication in the preconception period.
They found significant associations between longer time to conception and age (hazard ratio, 1.22; 95% confidence interval, 1.08-1.40; P < .001), and a much higher hazard ratio with the use of NSAIDs during preconception (HR, 3.01; 95% CI, 2.15-3.85; P = .01).
Some data unavailable
Ms. Hamroun acknowledged that no data were available on the frequency of sexual intercourse or quality of life, factors that could affect time to conception. Women were asked when they discontinued contraceptive use and actively began trying to become pregnant.
She stated that information on the dose of NSAIDs used by the patients was incomplete, noting, “We were therefore unable to adjust the results of our statistical analyses on the dose used by patients.”
Additionally, because the study participants were patients at tertiary centers in France and had more severe disease, the results may not be generalizable to all women of childbearing age. Patients with less severe SpA are often managed in outpatient settings in France, she said.
When asked about alternatives to NSAIDs, Ms. Hamroun said that anti–tumor necrosis factor agents with low placental passage may be a good alternative “if a woman with long-standing difficulties to conceive needs a regular use of NSAIDs to control disease activity, in the absence of any other cause of subfertility.”
The patient’s age must also be considered, she noted.
“A therapeutic switch may be favored in a woman over 35 years of age, for example, whose fertility is already impaired by age,” Ms. Hamroun said.
As for the mechanism that might explain the effects of NSAIDs on conception, Ms. Hamroun said that prostaglandins are essential to ovulation and embryo implantation and explained that NSAIDs may work against ovulation and result in poor implantation (miscarriage) by blocking prostaglandins.
She pointed out that her results are in line with the ACR’s recommendation to discontinue NSAID use during the preconception period in women with SpA who are having difficulty conceiving.
Control before conception is important
Sinead Maguire, MD, a clinical and research fellow in the Spondylitis Program at Toronto (Ont.) Western Hospital who was not part of the study, said the study highlights the importance of optimizing disease control before conception.
“There are a number of things rheumatologists can do to support our SpA patients when they are trying to conceive,” she told this news organization. “One of the most important issues to address is ensuring their SpA is in remission and continues to remain so. For that reason, if a woman is requiring regular NSAIDs for symptom control, the results of this study might encourage me to consider a biologic agent sooner to ensure remission.”
She urged women who want to become pregnant to discuss medications with their rheumatologist before trying to conceive.
“It is very exciting to see studies such as this so that rheumatologists can provide answers to our patients’ questions with evidence-based advice,” she said.
Ms. Hamroun and several coauthors had no disclosures. Other coauthors disclosed relationships with companies including Merck/MSD, Novartis, Janssen, AbbVie/Abbott, Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, Galapagos, Eli Lilly, Novartis, and/or UCB. Dr. Maguire reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
PHILADELPHIA – Women with spondyloarthritis (SpA) who are desiring pregnancy may want to consider decreasing use or discontinuing use (with supervision) of nonsteroidal anti-inflammatory drugs before conception, new data suggest.
Researchers have found a connection between NSAID use and age and a significantly longer time to conception among women with spondyloarthritis. Sabrina Hamroun, MMed, with the rheumatology department at the University Hospital Cochin, Paris, presented the findings during a press conference at the annual meeting of the American College of Rheumatology.
SpA commonly affects women of childbearing age, but data are sparse regarding the effects of disease on fertility.
Patients in the study were taken from the French multicenter cohort GR2 from 2015 to June 2021.
Among the 207 patients with SpA in the cohort, 88 were selected for analysis of time to conception. Of these, 56 patients (63.6%) had a clinical pregnancy during follow-up.
Subfertility group took an average of 16 months to get pregnant
Subfertility was observed in 40 (45.4%) of the women, with an average time to conception of 16.1 months. A woman was considered subfertile if her time to conception was more than 12 months or if she did not become pregnant.
The average preconception Bath Ankylosing Spondylitis Disease Activity Index score was 2.9 (+/- 2.1), the authors noted. The average age of the participants was 32 years.
Twenty-three patients were treated with NSAIDs, eight with corticosteroids, 12 with conventional synthetic disease-modifying antirheumatic drugs, and 61 with biologics.
Researchers adjusted for factors including age, body mass index, disease duration and severity, smoking, form of SpA (axial, peripheral, or both), and medication in the preconception period.
They found significant associations between longer time to conception and age (hazard ratio, 1.22; 95% confidence interval, 1.08-1.40; P < .001), and a much higher hazard ratio with the use of NSAIDs during preconception (HR, 3.01; 95% CI, 2.15-3.85; P = .01).
Some data unavailable
Ms. Hamroun acknowledged that no data were available on the frequency of sexual intercourse or quality of life, factors that could affect time to conception. Women were asked when they discontinued contraceptive use and actively began trying to become pregnant.
She stated that information on the dose of NSAIDs used by the patients was incomplete, noting, “We were therefore unable to adjust the results of our statistical analyses on the dose used by patients.”
Additionally, because the study participants were patients at tertiary centers in France and had more severe disease, the results may not be generalizable to all women of childbearing age. Patients with less severe SpA are often managed in outpatient settings in France, she said.
When asked about alternatives to NSAIDs, Ms. Hamroun said that anti–tumor necrosis factor agents with low placental passage may be a good alternative “if a woman with long-standing difficulties to conceive needs a regular use of NSAIDs to control disease activity, in the absence of any other cause of subfertility.”
The patient’s age must also be considered, she noted.
“A therapeutic switch may be favored in a woman over 35 years of age, for example, whose fertility is already impaired by age,” Ms. Hamroun said.
As for the mechanism that might explain the effects of NSAIDs on conception, Ms. Hamroun said that prostaglandins are essential to ovulation and embryo implantation and explained that NSAIDs may work against ovulation and result in poor implantation (miscarriage) by blocking prostaglandins.
She pointed out that her results are in line with the ACR’s recommendation to discontinue NSAID use during the preconception period in women with SpA who are having difficulty conceiving.
Control before conception is important
Sinead Maguire, MD, a clinical and research fellow in the Spondylitis Program at Toronto (Ont.) Western Hospital who was not part of the study, said the study highlights the importance of optimizing disease control before conception.
“There are a number of things rheumatologists can do to support our SpA patients when they are trying to conceive,” she told this news organization. “One of the most important issues to address is ensuring their SpA is in remission and continues to remain so. For that reason, if a woman is requiring regular NSAIDs for symptom control, the results of this study might encourage me to consider a biologic agent sooner to ensure remission.”
She urged women who want to become pregnant to discuss medications with their rheumatologist before trying to conceive.
“It is very exciting to see studies such as this so that rheumatologists can provide answers to our patients’ questions with evidence-based advice,” she said.
Ms. Hamroun and several coauthors had no disclosures. Other coauthors disclosed relationships with companies including Merck/MSD, Novartis, Janssen, AbbVie/Abbott, Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, Galapagos, Eli Lilly, Novartis, and/or UCB. Dr. Maguire reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ACR 2022
Analysis affirms that giving birth protects against endometrial cancer
Compared with having no children, the risk reduction for endometrial cancer was 21% with having one child, 38% with having two, and 51% with having three, Gunn-Helen Moen, MSc, PhD, a research fellow at the University of Queensland Institute for Molecular Bioscience in St. Lucia, Australia, and the senior author of the study, said in an email.
In the United States, the prevalence of endometrial cancer is 25.7 per 100,000 women per year, with a lifetime risk of 2.8%.
Multiple observational studies have linked giving birth to risk of endometrial cancer. For the new study, Dr. Moen and her team assessed various risk factors related to ovulation and reproductive function using Mendelian randomization, an epidemiological technique that deploys genetic variants to detect cause-and-effect relationships between potentially modifiable risk factors and health outcomes in observational data.
The researcher published their findings in BMC Medicine.
Leverage genetic data
The study used detailed genetic and health data from the UK Biobank, a databank with more than half a million participants. Genetic variants related to some of the risk factors were used to assess whether the variants make people more likely to develop endometrial cancer.
Genomewide significant single-nucleotide polymorphisms (SNPs) related to number of live births, age at menopause and menarche, and body mass index (BMI) had been identified in previous studies, the researchers reported. They conducted genomewide association analyses of the databank to identify SNPs associated with years ovulating, years using the contraceptive pill, and age at last live birth.
The MR analysis showed a potential causal effect for the number of live births (inverse variance–weighted odds ratio, 0.537) and number of years ovulating (IVW OR, 1.051), in addition to known risk factors of BMI, age at menarche, and age at menopause.
A further multivariable MR analysis showed that number of births had a negative causal effect on endometrial cancer risk (OR, 0.783), independent of the causal effect of known risk factors such as BMI, age at menarche and age at menopause.
Reported limitations included being unable to perform MR analyses on some factors, such as oral contraceptive use, because of a lack of valid genetic instruments. The researchers could not perform an age adjustment at diagnosis because of a lack of data.
In addition, the genetic data came exclusively from White women of European ancestry.
‘A personal choice’
Other investigators have hypothesized that the protective effect of childbirth may be caused by shedding of malignant and premalignant endometrial cells during and after childbirth and exposure to high levels of progesterone in late stages of pregnancy, the research team noted.
Dr. Moen said, based on the results, physicians might consider number of childbirths in assessing a patient’s risk of endometrial cancer.
However, Britton Trabert, MSPH, MS, PhD, an epidemiologist and assistant professor of obstetrics and gynecology at the University of Utah, Salt Lake City, said it’s unlikely the findings will affect clinical practice given that they “largely replicate well-characterized endometrial cancer risk associations.”
“Pregnancy and childbirth are a personal choice and is not largely regarded as a modifiable factor for cancer prevention,” said Dr. Trabert, who was not involved in the study.
The study’s investigators reported funding from the governments of Australia, Norway and the United Kingdom and the British Heart Foundation. No financial conflicts of interest were reported. Dr. Trabert reported no relevant financial interests.
Compared with having no children, the risk reduction for endometrial cancer was 21% with having one child, 38% with having two, and 51% with having three, Gunn-Helen Moen, MSc, PhD, a research fellow at the University of Queensland Institute for Molecular Bioscience in St. Lucia, Australia, and the senior author of the study, said in an email.
In the United States, the prevalence of endometrial cancer is 25.7 per 100,000 women per year, with a lifetime risk of 2.8%.
Multiple observational studies have linked giving birth to risk of endometrial cancer. For the new study, Dr. Moen and her team assessed various risk factors related to ovulation and reproductive function using Mendelian randomization, an epidemiological technique that deploys genetic variants to detect cause-and-effect relationships between potentially modifiable risk factors and health outcomes in observational data.
The researcher published their findings in BMC Medicine.
Leverage genetic data
The study used detailed genetic and health data from the UK Biobank, a databank with more than half a million participants. Genetic variants related to some of the risk factors were used to assess whether the variants make people more likely to develop endometrial cancer.
Genomewide significant single-nucleotide polymorphisms (SNPs) related to number of live births, age at menopause and menarche, and body mass index (BMI) had been identified in previous studies, the researchers reported. They conducted genomewide association analyses of the databank to identify SNPs associated with years ovulating, years using the contraceptive pill, and age at last live birth.
The MR analysis showed a potential causal effect for the number of live births (inverse variance–weighted odds ratio, 0.537) and number of years ovulating (IVW OR, 1.051), in addition to known risk factors of BMI, age at menarche, and age at menopause.
A further multivariable MR analysis showed that number of births had a negative causal effect on endometrial cancer risk (OR, 0.783), independent of the causal effect of known risk factors such as BMI, age at menarche and age at menopause.
Reported limitations included being unable to perform MR analyses on some factors, such as oral contraceptive use, because of a lack of valid genetic instruments. The researchers could not perform an age adjustment at diagnosis because of a lack of data.
In addition, the genetic data came exclusively from White women of European ancestry.
‘A personal choice’
Other investigators have hypothesized that the protective effect of childbirth may be caused by shedding of malignant and premalignant endometrial cells during and after childbirth and exposure to high levels of progesterone in late stages of pregnancy, the research team noted.
Dr. Moen said, based on the results, physicians might consider number of childbirths in assessing a patient’s risk of endometrial cancer.
However, Britton Trabert, MSPH, MS, PhD, an epidemiologist and assistant professor of obstetrics and gynecology at the University of Utah, Salt Lake City, said it’s unlikely the findings will affect clinical practice given that they “largely replicate well-characterized endometrial cancer risk associations.”
“Pregnancy and childbirth are a personal choice and is not largely regarded as a modifiable factor for cancer prevention,” said Dr. Trabert, who was not involved in the study.
The study’s investigators reported funding from the governments of Australia, Norway and the United Kingdom and the British Heart Foundation. No financial conflicts of interest were reported. Dr. Trabert reported no relevant financial interests.
Compared with having no children, the risk reduction for endometrial cancer was 21% with having one child, 38% with having two, and 51% with having three, Gunn-Helen Moen, MSc, PhD, a research fellow at the University of Queensland Institute for Molecular Bioscience in St. Lucia, Australia, and the senior author of the study, said in an email.
In the United States, the prevalence of endometrial cancer is 25.7 per 100,000 women per year, with a lifetime risk of 2.8%.
Multiple observational studies have linked giving birth to risk of endometrial cancer. For the new study, Dr. Moen and her team assessed various risk factors related to ovulation and reproductive function using Mendelian randomization, an epidemiological technique that deploys genetic variants to detect cause-and-effect relationships between potentially modifiable risk factors and health outcomes in observational data.
The researcher published their findings in BMC Medicine.
Leverage genetic data
The study used detailed genetic and health data from the UK Biobank, a databank with more than half a million participants. Genetic variants related to some of the risk factors were used to assess whether the variants make people more likely to develop endometrial cancer.
Genomewide significant single-nucleotide polymorphisms (SNPs) related to number of live births, age at menopause and menarche, and body mass index (BMI) had been identified in previous studies, the researchers reported. They conducted genomewide association analyses of the databank to identify SNPs associated with years ovulating, years using the contraceptive pill, and age at last live birth.
The MR analysis showed a potential causal effect for the number of live births (inverse variance–weighted odds ratio, 0.537) and number of years ovulating (IVW OR, 1.051), in addition to known risk factors of BMI, age at menarche, and age at menopause.
A further multivariable MR analysis showed that number of births had a negative causal effect on endometrial cancer risk (OR, 0.783), independent of the causal effect of known risk factors such as BMI, age at menarche and age at menopause.
Reported limitations included being unable to perform MR analyses on some factors, such as oral contraceptive use, because of a lack of valid genetic instruments. The researchers could not perform an age adjustment at diagnosis because of a lack of data.
In addition, the genetic data came exclusively from White women of European ancestry.
‘A personal choice’
Other investigators have hypothesized that the protective effect of childbirth may be caused by shedding of malignant and premalignant endometrial cells during and after childbirth and exposure to high levels of progesterone in late stages of pregnancy, the research team noted.
Dr. Moen said, based on the results, physicians might consider number of childbirths in assessing a patient’s risk of endometrial cancer.
However, Britton Trabert, MSPH, MS, PhD, an epidemiologist and assistant professor of obstetrics and gynecology at the University of Utah, Salt Lake City, said it’s unlikely the findings will affect clinical practice given that they “largely replicate well-characterized endometrial cancer risk associations.”
“Pregnancy and childbirth are a personal choice and is not largely regarded as a modifiable factor for cancer prevention,” said Dr. Trabert, who was not involved in the study.
The study’s investigators reported funding from the governments of Australia, Norway and the United Kingdom and the British Heart Foundation. No financial conflicts of interest were reported. Dr. Trabert reported no relevant financial interests.
FROM BMC MEDICINE
Test strips ID fetal tissue in vaginal blood
A rapid test strip can accurately identify embryonic or fetal tissue in vaginal blood at the bedside, say authors of a paper published in Obstetrics and Gynecology.
The strip, called the ROM Plus test, can detect alpha-fetoprotein (AFP) and insulin-like growth factor–binding protein 1 (IGFBP-1) to identify the presence of the tissue, researchers say.
A positive test could help diagnose miscarriage and rule out ectopic pregnancy.
The ROM Plus test was originally created for diagnosing rupture of amniotic membranes and has been approved by the Food and Drug Administration. This study describes an off-label use of the test.
Lead author Michelle Volovsky, MD, of the department of obstetrics and gynecology at Maimonides Medical Center in Brooklyn, N.Y., said that in the current legal climate for abortion care, the test could have an additional use for women having vaginal bleeding.
“This test could be used as evidence to confirm that a miscarriage has occurred, and hence, a D&C (dilation and curettage) procedure in that case is not an induced abortion of a viable pregnancy,” Dr. Volovsky said.
Women in study
Three groups of reproductive-age women (totaling 90) were included in the study.
One was a negative control group consisting of nonpregnant women undergoing D&C or experiencing vaginal bleeding (n = 23). The positive control group of women had confirmed intrauterine pregnancy undergoing D&C (n = 31), and the third group was a study group of pregnant women with first-trimester bleeding (n = 36). Twelve women in the study group had confirmed ectopic pregnancies.
High sensitivity and specificity
Overall, 47 women had confirmed embryonic or fetal tissue in vaginal or uterine blood samples. The test strip was accurately positive in 45 of those 47 cases for a test sensitivity of 95.7%. The other 43 had confirmed absence of embryonic or fetal tissue in their vaginal or uterine blood samples.
The test had high specificity as well. “In the absence of embryonic or fetal tissue, such as vaginal blood sampled in cases of ectopic pregnancy, threatened or complete miscarriage, or nonpregnant individuals, the test strip had a specificity of 97.7% for obtaining a negative result,” the authors wrote.
The researchers noted that the high sensitivity and specificity were seen as all tests were performed in real-time, common clinical scenarios encountered in a high-volume, urban ob.gyn. unit.
First-trimester bleeding can be common
First-trimester bleeding occurs in 20%-40% of pregnancies and results in almost 500,000 emergency department visits in the United States every year, the authors wrote.
The most common causes include threatened miscarriage, but more serious etiologies include ectopic pregnancy.
Because criteria often are not met for ectopic pregnancy, many women are told they have a pregnancy of unknown location, which can lead to extensive and expensive follow-up.
“The current study was designed to offer a simple diagnostic alternative that does not require the use of an automated laboratory analyzer,” the authors wrote.
The test could be used by patients with confirmed intrauterine pregnancies at home – a highly desirable feature for people hesitant to come into medical offices or who live in remote areas, they noted.
Questions about test’s use
Lauren Thaxton, MD, assistant professor in the department of women’s health at the University of Texas at Austin, told this publication she sees the ease of use by patients at home as the biggest benefit of the test strips.
She said she’s not sure they would add much benefit otherwise because “we already have a pretty great way of identifying pregnancy tissue by floating the products of conception.”
She said the traditional “floating products” method is very inexpensive, involving a pan and strainer, and may be more comprehensive in that it can determine whether a miscarriage is finished.
She also wonders whether in the current legal climate of abortion laws, the test could be used not only to prove that an abortion didn’t happen but used as evidence the opposite way to criminalize abortion.
It’s unfortunate that we are evaluating new technology as ‘could this cause more harm than good?’ But I think it would be wrong not to recognize the long history of criminalization of abortion as well as the current reproductive health and policy climate,” Dr. Thaxton said.
Coauthors Amir Mor, MD, PhD, and Hugh Taylor, MD, hold U.S. patent rights related to the methods described in this article. Coauthor David Seifer, MD, received payment from the Women’s Integrated Network and Rutgers Medical School. In this article the authors describe off-label use of the ROM Plus test kit, produced by Laborie USA. This device was used to test vaginal blood for the presence of embryonic or fetal products. The other authors did not report any potential conflicts of interest. Dr. Thaxton reports no relevant financial relationships.
A rapid test strip can accurately identify embryonic or fetal tissue in vaginal blood at the bedside, say authors of a paper published in Obstetrics and Gynecology.
The strip, called the ROM Plus test, can detect alpha-fetoprotein (AFP) and insulin-like growth factor–binding protein 1 (IGFBP-1) to identify the presence of the tissue, researchers say.
A positive test could help diagnose miscarriage and rule out ectopic pregnancy.
The ROM Plus test was originally created for diagnosing rupture of amniotic membranes and has been approved by the Food and Drug Administration. This study describes an off-label use of the test.
Lead author Michelle Volovsky, MD, of the department of obstetrics and gynecology at Maimonides Medical Center in Brooklyn, N.Y., said that in the current legal climate for abortion care, the test could have an additional use for women having vaginal bleeding.
“This test could be used as evidence to confirm that a miscarriage has occurred, and hence, a D&C (dilation and curettage) procedure in that case is not an induced abortion of a viable pregnancy,” Dr. Volovsky said.
Women in study
Three groups of reproductive-age women (totaling 90) were included in the study.
One was a negative control group consisting of nonpregnant women undergoing D&C or experiencing vaginal bleeding (n = 23). The positive control group of women had confirmed intrauterine pregnancy undergoing D&C (n = 31), and the third group was a study group of pregnant women with first-trimester bleeding (n = 36). Twelve women in the study group had confirmed ectopic pregnancies.
High sensitivity and specificity
Overall, 47 women had confirmed embryonic or fetal tissue in vaginal or uterine blood samples. The test strip was accurately positive in 45 of those 47 cases for a test sensitivity of 95.7%. The other 43 had confirmed absence of embryonic or fetal tissue in their vaginal or uterine blood samples.
The test had high specificity as well. “In the absence of embryonic or fetal tissue, such as vaginal blood sampled in cases of ectopic pregnancy, threatened or complete miscarriage, or nonpregnant individuals, the test strip had a specificity of 97.7% for obtaining a negative result,” the authors wrote.
The researchers noted that the high sensitivity and specificity were seen as all tests were performed in real-time, common clinical scenarios encountered in a high-volume, urban ob.gyn. unit.
First-trimester bleeding can be common
First-trimester bleeding occurs in 20%-40% of pregnancies and results in almost 500,000 emergency department visits in the United States every year, the authors wrote.
The most common causes include threatened miscarriage, but more serious etiologies include ectopic pregnancy.
Because criteria often are not met for ectopic pregnancy, many women are told they have a pregnancy of unknown location, which can lead to extensive and expensive follow-up.
“The current study was designed to offer a simple diagnostic alternative that does not require the use of an automated laboratory analyzer,” the authors wrote.
The test could be used by patients with confirmed intrauterine pregnancies at home – a highly desirable feature for people hesitant to come into medical offices or who live in remote areas, they noted.
Questions about test’s use
Lauren Thaxton, MD, assistant professor in the department of women’s health at the University of Texas at Austin, told this publication she sees the ease of use by patients at home as the biggest benefit of the test strips.
She said she’s not sure they would add much benefit otherwise because “we already have a pretty great way of identifying pregnancy tissue by floating the products of conception.”
She said the traditional “floating products” method is very inexpensive, involving a pan and strainer, and may be more comprehensive in that it can determine whether a miscarriage is finished.
She also wonders whether in the current legal climate of abortion laws, the test could be used not only to prove that an abortion didn’t happen but used as evidence the opposite way to criminalize abortion.
It’s unfortunate that we are evaluating new technology as ‘could this cause more harm than good?’ But I think it would be wrong not to recognize the long history of criminalization of abortion as well as the current reproductive health and policy climate,” Dr. Thaxton said.
Coauthors Amir Mor, MD, PhD, and Hugh Taylor, MD, hold U.S. patent rights related to the methods described in this article. Coauthor David Seifer, MD, received payment from the Women’s Integrated Network and Rutgers Medical School. In this article the authors describe off-label use of the ROM Plus test kit, produced by Laborie USA. This device was used to test vaginal blood for the presence of embryonic or fetal products. The other authors did not report any potential conflicts of interest. Dr. Thaxton reports no relevant financial relationships.
A rapid test strip can accurately identify embryonic or fetal tissue in vaginal blood at the bedside, say authors of a paper published in Obstetrics and Gynecology.
The strip, called the ROM Plus test, can detect alpha-fetoprotein (AFP) and insulin-like growth factor–binding protein 1 (IGFBP-1) to identify the presence of the tissue, researchers say.
A positive test could help diagnose miscarriage and rule out ectopic pregnancy.
The ROM Plus test was originally created for diagnosing rupture of amniotic membranes and has been approved by the Food and Drug Administration. This study describes an off-label use of the test.
Lead author Michelle Volovsky, MD, of the department of obstetrics and gynecology at Maimonides Medical Center in Brooklyn, N.Y., said that in the current legal climate for abortion care, the test could have an additional use for women having vaginal bleeding.
“This test could be used as evidence to confirm that a miscarriage has occurred, and hence, a D&C (dilation and curettage) procedure in that case is not an induced abortion of a viable pregnancy,” Dr. Volovsky said.
Women in study
Three groups of reproductive-age women (totaling 90) were included in the study.
One was a negative control group consisting of nonpregnant women undergoing D&C or experiencing vaginal bleeding (n = 23). The positive control group of women had confirmed intrauterine pregnancy undergoing D&C (n = 31), and the third group was a study group of pregnant women with first-trimester bleeding (n = 36). Twelve women in the study group had confirmed ectopic pregnancies.
High sensitivity and specificity
Overall, 47 women had confirmed embryonic or fetal tissue in vaginal or uterine blood samples. The test strip was accurately positive in 45 of those 47 cases for a test sensitivity of 95.7%. The other 43 had confirmed absence of embryonic or fetal tissue in their vaginal or uterine blood samples.
The test had high specificity as well. “In the absence of embryonic or fetal tissue, such as vaginal blood sampled in cases of ectopic pregnancy, threatened or complete miscarriage, or nonpregnant individuals, the test strip had a specificity of 97.7% for obtaining a negative result,” the authors wrote.
The researchers noted that the high sensitivity and specificity were seen as all tests were performed in real-time, common clinical scenarios encountered in a high-volume, urban ob.gyn. unit.
First-trimester bleeding can be common
First-trimester bleeding occurs in 20%-40% of pregnancies and results in almost 500,000 emergency department visits in the United States every year, the authors wrote.
The most common causes include threatened miscarriage, but more serious etiologies include ectopic pregnancy.
Because criteria often are not met for ectopic pregnancy, many women are told they have a pregnancy of unknown location, which can lead to extensive and expensive follow-up.
“The current study was designed to offer a simple diagnostic alternative that does not require the use of an automated laboratory analyzer,” the authors wrote.
The test could be used by patients with confirmed intrauterine pregnancies at home – a highly desirable feature for people hesitant to come into medical offices or who live in remote areas, they noted.
Questions about test’s use
Lauren Thaxton, MD, assistant professor in the department of women’s health at the University of Texas at Austin, told this publication she sees the ease of use by patients at home as the biggest benefit of the test strips.
She said she’s not sure they would add much benefit otherwise because “we already have a pretty great way of identifying pregnancy tissue by floating the products of conception.”
She said the traditional “floating products” method is very inexpensive, involving a pan and strainer, and may be more comprehensive in that it can determine whether a miscarriage is finished.
She also wonders whether in the current legal climate of abortion laws, the test could be used not only to prove that an abortion didn’t happen but used as evidence the opposite way to criminalize abortion.
It’s unfortunate that we are evaluating new technology as ‘could this cause more harm than good?’ But I think it would be wrong not to recognize the long history of criminalization of abortion as well as the current reproductive health and policy climate,” Dr. Thaxton said.
Coauthors Amir Mor, MD, PhD, and Hugh Taylor, MD, hold U.S. patent rights related to the methods described in this article. Coauthor David Seifer, MD, received payment from the Women’s Integrated Network and Rutgers Medical School. In this article the authors describe off-label use of the ROM Plus test kit, produced by Laborie USA. This device was used to test vaginal blood for the presence of embryonic or fetal products. The other authors did not report any potential conflicts of interest. Dr. Thaxton reports no relevant financial relationships.
FROM OBSTETRICS AND GYNECOLOGY
Treating deadly disease in utero called ‘revolutionary’ advance
The successful treatment of Pompe disease in utero for the first time may be the start of a new chapter for fetal therapy, researchers said.
A report published online in the New England Journal of Medicine describes in utero enzyme-replacement therapy (ERT) for infantile-onset Pompe disease.
The patient, now a toddler, is thriving, according to the researchers. Her parents previously had children with the same disorder who died.
“This treatment expands the repertoire of fetal therapies in a new direction,” Tippi MacKenzie, MD, a pediatric surgeon with University of California, San Francisco, Benioff Children’s Hospitals and a coauthor of the report, said in a news release. “As new treatments become available for children with genetic conditions, we are developing protocols to apply them before birth.”
Dr. MacKenzie codirects the University of California, San Francisco’s center for maternal-fetal precision medicine and directs the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research.
Pompe disease is caused by mutations in a gene that makes acid alpha-glucosidase. With limited amounts of this enzyme, dangerous amounts of glycogen accumulate in the body. Babies with infantile-onset disease typically have enlarged hearts and die by age 2 years.
The condition, which occurs in an estimated 1 in 40,000 births, is one of several early-onset lysosomal storage disorders. Patients with these diseases “are ideal candidates for prenatal therapy because organ damage starts in utero,” the researchers said.
Newborn screening can lead to early initiation of treatment with recombinant enzymes, “but this strategy does not completely prevent irreversible organ damage,” the authors said.
The patient in the new report received six prenatal ERT treatments at the Ottawa Hospital and is receiving postnatal enzyme therapy at CHEO, a pediatric hospital and research center in Ottawa.
Investigators administered alglucosidase alfa through the umbilical vein. They delivered the first infusion to the fetus at 24 weeks 5 days of gestation. They continued providing infusions at 2-week intervals through 34 weeks 5 days of gestation.
She is doing well at age 16 months, with normal cardiac and motor function, and is meeting developmental milestones, according to the news release.
The successful treatment involved collaboration among the University of California, San Francisco, where researchers are conducting a clinical trial of this treatment approach; CHEO and the Ottawa Hospital; and Duke University, Durham, N.C.
Under normal circumstances, the patient’s family would have traveled to Benioff Children’s Hospitals fetal treatment center to participate in the clinical trial, but COVID-19 restrictions led the researchers to deliver the therapy to Ottawa as part of the trial.
The University of California, San Francisco, has received U.S. Food and Drug Administration approval to treat Pompe disease and several other lysosomal storage disorders in utero as part of a phase 1 clinical trial with 10 patients. The other diseases are mucopolysaccharidosis types 1, 2, 4a, 6, and 7; Gaucher disease types 2 and 3; and Wolman disease.
Patients with Pompe disease might typically be diagnosed clinically at age 3-6 months, said study coauthor Paul Harmatz, MD, with the University of California, San Francisco. With newborn screening, the disease might be diagnosed at 1 week. But intervening before birth may be optimal, Dr. Harmatz said.
Fetal treatment appears to be “revolutionary at this point,” Dr. Harmatz said.
The research was supported by a grant from the National Institutes of Health. Sanofi Genzyme provided the enzyme for the patient.
A version of this article first appeared on Medscape.com.
The successful treatment of Pompe disease in utero for the first time may be the start of a new chapter for fetal therapy, researchers said.
A report published online in the New England Journal of Medicine describes in utero enzyme-replacement therapy (ERT) for infantile-onset Pompe disease.
The patient, now a toddler, is thriving, according to the researchers. Her parents previously had children with the same disorder who died.
“This treatment expands the repertoire of fetal therapies in a new direction,” Tippi MacKenzie, MD, a pediatric surgeon with University of California, San Francisco, Benioff Children’s Hospitals and a coauthor of the report, said in a news release. “As new treatments become available for children with genetic conditions, we are developing protocols to apply them before birth.”
Dr. MacKenzie codirects the University of California, San Francisco’s center for maternal-fetal precision medicine and directs the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research.
Pompe disease is caused by mutations in a gene that makes acid alpha-glucosidase. With limited amounts of this enzyme, dangerous amounts of glycogen accumulate in the body. Babies with infantile-onset disease typically have enlarged hearts and die by age 2 years.
The condition, which occurs in an estimated 1 in 40,000 births, is one of several early-onset lysosomal storage disorders. Patients with these diseases “are ideal candidates for prenatal therapy because organ damage starts in utero,” the researchers said.
Newborn screening can lead to early initiation of treatment with recombinant enzymes, “but this strategy does not completely prevent irreversible organ damage,” the authors said.
The patient in the new report received six prenatal ERT treatments at the Ottawa Hospital and is receiving postnatal enzyme therapy at CHEO, a pediatric hospital and research center in Ottawa.
Investigators administered alglucosidase alfa through the umbilical vein. They delivered the first infusion to the fetus at 24 weeks 5 days of gestation. They continued providing infusions at 2-week intervals through 34 weeks 5 days of gestation.
She is doing well at age 16 months, with normal cardiac and motor function, and is meeting developmental milestones, according to the news release.
The successful treatment involved collaboration among the University of California, San Francisco, where researchers are conducting a clinical trial of this treatment approach; CHEO and the Ottawa Hospital; and Duke University, Durham, N.C.
Under normal circumstances, the patient’s family would have traveled to Benioff Children’s Hospitals fetal treatment center to participate in the clinical trial, but COVID-19 restrictions led the researchers to deliver the therapy to Ottawa as part of the trial.
The University of California, San Francisco, has received U.S. Food and Drug Administration approval to treat Pompe disease and several other lysosomal storage disorders in utero as part of a phase 1 clinical trial with 10 patients. The other diseases are mucopolysaccharidosis types 1, 2, 4a, 6, and 7; Gaucher disease types 2 and 3; and Wolman disease.
Patients with Pompe disease might typically be diagnosed clinically at age 3-6 months, said study coauthor Paul Harmatz, MD, with the University of California, San Francisco. With newborn screening, the disease might be diagnosed at 1 week. But intervening before birth may be optimal, Dr. Harmatz said.
Fetal treatment appears to be “revolutionary at this point,” Dr. Harmatz said.
The research was supported by a grant from the National Institutes of Health. Sanofi Genzyme provided the enzyme for the patient.
A version of this article first appeared on Medscape.com.
The successful treatment of Pompe disease in utero for the first time may be the start of a new chapter for fetal therapy, researchers said.
A report published online in the New England Journal of Medicine describes in utero enzyme-replacement therapy (ERT) for infantile-onset Pompe disease.
The patient, now a toddler, is thriving, according to the researchers. Her parents previously had children with the same disorder who died.
“This treatment expands the repertoire of fetal therapies in a new direction,” Tippi MacKenzie, MD, a pediatric surgeon with University of California, San Francisco, Benioff Children’s Hospitals and a coauthor of the report, said in a news release. “As new treatments become available for children with genetic conditions, we are developing protocols to apply them before birth.”
Dr. MacKenzie codirects the University of California, San Francisco’s center for maternal-fetal precision medicine and directs the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research.
Pompe disease is caused by mutations in a gene that makes acid alpha-glucosidase. With limited amounts of this enzyme, dangerous amounts of glycogen accumulate in the body. Babies with infantile-onset disease typically have enlarged hearts and die by age 2 years.
The condition, which occurs in an estimated 1 in 40,000 births, is one of several early-onset lysosomal storage disorders. Patients with these diseases “are ideal candidates for prenatal therapy because organ damage starts in utero,” the researchers said.
Newborn screening can lead to early initiation of treatment with recombinant enzymes, “but this strategy does not completely prevent irreversible organ damage,” the authors said.
The patient in the new report received six prenatal ERT treatments at the Ottawa Hospital and is receiving postnatal enzyme therapy at CHEO, a pediatric hospital and research center in Ottawa.
Investigators administered alglucosidase alfa through the umbilical vein. They delivered the first infusion to the fetus at 24 weeks 5 days of gestation. They continued providing infusions at 2-week intervals through 34 weeks 5 days of gestation.
She is doing well at age 16 months, with normal cardiac and motor function, and is meeting developmental milestones, according to the news release.
The successful treatment involved collaboration among the University of California, San Francisco, where researchers are conducting a clinical trial of this treatment approach; CHEO and the Ottawa Hospital; and Duke University, Durham, N.C.
Under normal circumstances, the patient’s family would have traveled to Benioff Children’s Hospitals fetal treatment center to participate in the clinical trial, but COVID-19 restrictions led the researchers to deliver the therapy to Ottawa as part of the trial.
The University of California, San Francisco, has received U.S. Food and Drug Administration approval to treat Pompe disease and several other lysosomal storage disorders in utero as part of a phase 1 clinical trial with 10 patients. The other diseases are mucopolysaccharidosis types 1, 2, 4a, 6, and 7; Gaucher disease types 2 and 3; and Wolman disease.
Patients with Pompe disease might typically be diagnosed clinically at age 3-6 months, said study coauthor Paul Harmatz, MD, with the University of California, San Francisco. With newborn screening, the disease might be diagnosed at 1 week. But intervening before birth may be optimal, Dr. Harmatz said.
Fetal treatment appears to be “revolutionary at this point,” Dr. Harmatz said.
The research was supported by a grant from the National Institutes of Health. Sanofi Genzyme provided the enzyme for the patient.
A version of this article first appeared on Medscape.com.
Physicians react: Climate change and other social issues
Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.
Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
Relevance of climate change to health care
In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.
What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”
However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.
And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
Domestic violence: What physicians can do
About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.
Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”
Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
Expanding legal immigration
In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.
“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.
A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.
A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
Reproductive rights: No easy answers
Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.
At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.
While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”
A version of this article first appeared on Medscape.com.
Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.
Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
Relevance of climate change to health care
In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.
What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”
However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.
And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
Domestic violence: What physicians can do
About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.
Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”
Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
Expanding legal immigration
In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.
“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.
A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.
A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
Reproductive rights: No easy answers
Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.
At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.
While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”
A version of this article first appeared on Medscape.com.
Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.
Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
Relevance of climate change to health care
In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.
What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”
However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.
And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
Domestic violence: What physicians can do
About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.
Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”
Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
Expanding legal immigration
In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.
“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.
A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.
A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
Reproductive rights: No easy answers
Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.
At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.
While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”
A version of this article first appeared on Medscape.com.
Previous breast cancer doesn’t increase poor outcomes in pregnancy, study finds
A new retrospective study provides more evidence that previous breast cancer diagnoses don’t disrupt the health of mothers and newborns in pregnancy: Women who became pregnant at least 12 months after breast cancer diagnosis weren’t more likely than a control group to have preterm births or suffer maternal/neonatal morbidity – even though they were more likely to undergo cesarean section.
“For patients who are more than 1 year out from the diagnosis of breast cancer, it may be safe and reasonable to consider pregnancy without significantly increased odds of maternal or neonatal complications,” said study lead author Kirsten Jorgensen, MD, a gynecologic oncology fellow at the University of Texas Houston School of Public Health, in an interview. “This study does not suggest there is no risk, but it does place the risk that exists in context with the risk that is associated with any pregnancy.”
The study appears in Obstetrics & Gynecology.
The researchers launched the analysis because “there is relatively little data to help guide patients, their oncologists, and their obstetricians as they navigate the potential for pregnancy after a cancer diagnosis,” Dr. Jorgensen said. “There have been prior studies looking at birth outcomes, but they often include people who become pregnant very shortly after diagnosis, which may skew results.”
Researchers used databases to track 30,021 women in California aged 18-45 who were diagnosed with breast cancer from 2000 to 2012. Of those, only 553 met the study criteria and conceived at least 1 year after a stage I-III breast cancer diagnosis (median age at delivery = 36; 50.6% non-Hispanic White, 23.9% Hispanic, 6.0% Black; 83.2% private insurance).
Study authors compared these women to a matched control group of 1,659 women without breast cancer.
After adjustment for various factors, there was no significant difference between the groups in terms of maternal outcomes – preterm birth at less than 37 weeks of gestation (12.5% in the breast cancer group vs. 10.0% in the control group; odds ratio = 1.29; 95% confidence interval, 0.95-1.74) or preterm birth at less than 32 weeks of gestation (1.3% vs. 1.6%, respectively, OR = 0.77; 95% CI, 0.34-1.79).
Researchers didn’t find a significant difference in neonatal outcomes either – small for gestational age (less than the 5th percentile, 3.1% vs. 5.0%, respectively; OR = 0.60, 95% CI, 0.35-1.03; less than the 10th percentile: 9.4% vs. 10%, respectively; OR = 0.94; 95% CI, 0.68-1.30), or neonatal morbidity (8.7% vs. 7.7%, respectively; OR = 1.15; 95% CI, 0.81-1.62).
“It is possible that breast cancer may have little impact because some breast cancer is treated only with surgery or radiation to the chest,” Dr. Jorgensen said. “These treatments likely do not impact fertility and may not impact a developing pregnancy.”
There were neonatal deaths: one in the breast cancer group and four in the control group. The researchers said the small number of deaths limited their ability to interpret the data.
Researchers found no evidence that treatment with chemotherapy affected outcomes. They did turn up a difference between the groups: those who’d had breast cancer were more likely to undergo cesarean delivery (45.6% in the breast cancer group, and 40.1% in the control group; OR = 1.25; 95% CI 1.03-1.53), However, offspring of women in the cesarean group weren’t more likely to have neonatal morbidity (OR = 1.15; 95% CI 0.81-1.62).
It’s hard to explain the higher rate of cesarean deliveries in the breast cancer group, Dr. Jorgensen said. “Overall, among our study population and the matched controls there was a high rate of cesarean section. It is possible there was bias on the provider side. Perhaps they intervened with cesarean section earlier among those with a history of breast cancer – a type of bias due to knowing the history of the patient. We attempted to match for other comorbidities that impact obstetric outcomes, but it is possible that we did not account for all of them.”
In an interview, Patricia A. Ganz, MD, director of cancer prevention and control research at University of California, Los Angeles, praised the new research.
It’s “a well-conducted study with state-of-the-art analysis and interpretation,” she said. “Based on my experience with patients I have cared for with breast cancer, there were no surprises here. Most have had uncomplicated pregnancies. This should be reassuring for women who wish to have children after treatment for breast cancer and clinicians should support this decision.”
As for the higher rate of cesarean delivery in breast-cancer survivors, she said “there may be a tendency to think of these as ‘high risk’ pregnancies, and C-sections may be selected at a more frequent rate as a result.”
The study was funded by the National Institutes of Health, including grants from the National Cancer Institute and the National Center for Advancing Translational Sciences. Dr. Jorgensen has no disclosures. Other authors disclosed advisory board service (Delfina Care) and payments from the NIH, Guidepoint, the Schlesinger Group, and Johnson & Johnson. Dr. Ganz has no disclosures.
A new retrospective study provides more evidence that previous breast cancer diagnoses don’t disrupt the health of mothers and newborns in pregnancy: Women who became pregnant at least 12 months after breast cancer diagnosis weren’t more likely than a control group to have preterm births or suffer maternal/neonatal morbidity – even though they were more likely to undergo cesarean section.
“For patients who are more than 1 year out from the diagnosis of breast cancer, it may be safe and reasonable to consider pregnancy without significantly increased odds of maternal or neonatal complications,” said study lead author Kirsten Jorgensen, MD, a gynecologic oncology fellow at the University of Texas Houston School of Public Health, in an interview. “This study does not suggest there is no risk, but it does place the risk that exists in context with the risk that is associated with any pregnancy.”
The study appears in Obstetrics & Gynecology.
The researchers launched the analysis because “there is relatively little data to help guide patients, their oncologists, and their obstetricians as they navigate the potential for pregnancy after a cancer diagnosis,” Dr. Jorgensen said. “There have been prior studies looking at birth outcomes, but they often include people who become pregnant very shortly after diagnosis, which may skew results.”
Researchers used databases to track 30,021 women in California aged 18-45 who were diagnosed with breast cancer from 2000 to 2012. Of those, only 553 met the study criteria and conceived at least 1 year after a stage I-III breast cancer diagnosis (median age at delivery = 36; 50.6% non-Hispanic White, 23.9% Hispanic, 6.0% Black; 83.2% private insurance).
Study authors compared these women to a matched control group of 1,659 women without breast cancer.
After adjustment for various factors, there was no significant difference between the groups in terms of maternal outcomes – preterm birth at less than 37 weeks of gestation (12.5% in the breast cancer group vs. 10.0% in the control group; odds ratio = 1.29; 95% confidence interval, 0.95-1.74) or preterm birth at less than 32 weeks of gestation (1.3% vs. 1.6%, respectively, OR = 0.77; 95% CI, 0.34-1.79).
Researchers didn’t find a significant difference in neonatal outcomes either – small for gestational age (less than the 5th percentile, 3.1% vs. 5.0%, respectively; OR = 0.60, 95% CI, 0.35-1.03; less than the 10th percentile: 9.4% vs. 10%, respectively; OR = 0.94; 95% CI, 0.68-1.30), or neonatal morbidity (8.7% vs. 7.7%, respectively; OR = 1.15; 95% CI, 0.81-1.62).
“It is possible that breast cancer may have little impact because some breast cancer is treated only with surgery or radiation to the chest,” Dr. Jorgensen said. “These treatments likely do not impact fertility and may not impact a developing pregnancy.”
There were neonatal deaths: one in the breast cancer group and four in the control group. The researchers said the small number of deaths limited their ability to interpret the data.
Researchers found no evidence that treatment with chemotherapy affected outcomes. They did turn up a difference between the groups: those who’d had breast cancer were more likely to undergo cesarean delivery (45.6% in the breast cancer group, and 40.1% in the control group; OR = 1.25; 95% CI 1.03-1.53), However, offspring of women in the cesarean group weren’t more likely to have neonatal morbidity (OR = 1.15; 95% CI 0.81-1.62).
It’s hard to explain the higher rate of cesarean deliveries in the breast cancer group, Dr. Jorgensen said. “Overall, among our study population and the matched controls there was a high rate of cesarean section. It is possible there was bias on the provider side. Perhaps they intervened with cesarean section earlier among those with a history of breast cancer – a type of bias due to knowing the history of the patient. We attempted to match for other comorbidities that impact obstetric outcomes, but it is possible that we did not account for all of them.”
In an interview, Patricia A. Ganz, MD, director of cancer prevention and control research at University of California, Los Angeles, praised the new research.
It’s “a well-conducted study with state-of-the-art analysis and interpretation,” she said. “Based on my experience with patients I have cared for with breast cancer, there were no surprises here. Most have had uncomplicated pregnancies. This should be reassuring for women who wish to have children after treatment for breast cancer and clinicians should support this decision.”
As for the higher rate of cesarean delivery in breast-cancer survivors, she said “there may be a tendency to think of these as ‘high risk’ pregnancies, and C-sections may be selected at a more frequent rate as a result.”
The study was funded by the National Institutes of Health, including grants from the National Cancer Institute and the National Center for Advancing Translational Sciences. Dr. Jorgensen has no disclosures. Other authors disclosed advisory board service (Delfina Care) and payments from the NIH, Guidepoint, the Schlesinger Group, and Johnson & Johnson. Dr. Ganz has no disclosures.
A new retrospective study provides more evidence that previous breast cancer diagnoses don’t disrupt the health of mothers and newborns in pregnancy: Women who became pregnant at least 12 months after breast cancer diagnosis weren’t more likely than a control group to have preterm births or suffer maternal/neonatal morbidity – even though they were more likely to undergo cesarean section.
“For patients who are more than 1 year out from the diagnosis of breast cancer, it may be safe and reasonable to consider pregnancy without significantly increased odds of maternal or neonatal complications,” said study lead author Kirsten Jorgensen, MD, a gynecologic oncology fellow at the University of Texas Houston School of Public Health, in an interview. “This study does not suggest there is no risk, but it does place the risk that exists in context with the risk that is associated with any pregnancy.”
The study appears in Obstetrics & Gynecology.
The researchers launched the analysis because “there is relatively little data to help guide patients, their oncologists, and their obstetricians as they navigate the potential for pregnancy after a cancer diagnosis,” Dr. Jorgensen said. “There have been prior studies looking at birth outcomes, but they often include people who become pregnant very shortly after diagnosis, which may skew results.”
Researchers used databases to track 30,021 women in California aged 18-45 who were diagnosed with breast cancer from 2000 to 2012. Of those, only 553 met the study criteria and conceived at least 1 year after a stage I-III breast cancer diagnosis (median age at delivery = 36; 50.6% non-Hispanic White, 23.9% Hispanic, 6.0% Black; 83.2% private insurance).
Study authors compared these women to a matched control group of 1,659 women without breast cancer.
After adjustment for various factors, there was no significant difference between the groups in terms of maternal outcomes – preterm birth at less than 37 weeks of gestation (12.5% in the breast cancer group vs. 10.0% in the control group; odds ratio = 1.29; 95% confidence interval, 0.95-1.74) or preterm birth at less than 32 weeks of gestation (1.3% vs. 1.6%, respectively, OR = 0.77; 95% CI, 0.34-1.79).
Researchers didn’t find a significant difference in neonatal outcomes either – small for gestational age (less than the 5th percentile, 3.1% vs. 5.0%, respectively; OR = 0.60, 95% CI, 0.35-1.03; less than the 10th percentile: 9.4% vs. 10%, respectively; OR = 0.94; 95% CI, 0.68-1.30), or neonatal morbidity (8.7% vs. 7.7%, respectively; OR = 1.15; 95% CI, 0.81-1.62).
“It is possible that breast cancer may have little impact because some breast cancer is treated only with surgery or radiation to the chest,” Dr. Jorgensen said. “These treatments likely do not impact fertility and may not impact a developing pregnancy.”
There were neonatal deaths: one in the breast cancer group and four in the control group. The researchers said the small number of deaths limited their ability to interpret the data.
Researchers found no evidence that treatment with chemotherapy affected outcomes. They did turn up a difference between the groups: those who’d had breast cancer were more likely to undergo cesarean delivery (45.6% in the breast cancer group, and 40.1% in the control group; OR = 1.25; 95% CI 1.03-1.53), However, offspring of women in the cesarean group weren’t more likely to have neonatal morbidity (OR = 1.15; 95% CI 0.81-1.62).
It’s hard to explain the higher rate of cesarean deliveries in the breast cancer group, Dr. Jorgensen said. “Overall, among our study population and the matched controls there was a high rate of cesarean section. It is possible there was bias on the provider side. Perhaps they intervened with cesarean section earlier among those with a history of breast cancer – a type of bias due to knowing the history of the patient. We attempted to match for other comorbidities that impact obstetric outcomes, but it is possible that we did not account for all of them.”
In an interview, Patricia A. Ganz, MD, director of cancer prevention and control research at University of California, Los Angeles, praised the new research.
It’s “a well-conducted study with state-of-the-art analysis and interpretation,” she said. “Based on my experience with patients I have cared for with breast cancer, there were no surprises here. Most have had uncomplicated pregnancies. This should be reassuring for women who wish to have children after treatment for breast cancer and clinicians should support this decision.”
As for the higher rate of cesarean delivery in breast-cancer survivors, she said “there may be a tendency to think of these as ‘high risk’ pregnancies, and C-sections may be selected at a more frequent rate as a result.”
The study was funded by the National Institutes of Health, including grants from the National Cancer Institute and the National Center for Advancing Translational Sciences. Dr. Jorgensen has no disclosures. Other authors disclosed advisory board service (Delfina Care) and payments from the NIH, Guidepoint, the Schlesinger Group, and Johnson & Johnson. Dr. Ganz has no disclosures.
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