User login
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
The clitoris steps into the spotlight with major scientific discovery
The patients of Jill Krapf, MD, are often too embarrassed to tell her about discomfort in their clitoris.
“I ask all of my patients about clitoral pain, and it is often the first time they have ever been asked about this,” says Dr. Krapf, the associate director of the Center for Vulvovaginal Disorders, a private clinic in Washington and New York.
Dr. Krapf is an ob.gyn. who specializes in female sexual pain that involves the pelvis, vagina, and vulva.
Many of the conditions Dr. Krapf treats don’t have outward symptoms that appear abnormal, but internally, there are damaged or irritated nerves that can result in hypersensitivity, unwanted arousal, or pain.
“Most recent research indicates that even a herniated disk or tear in the spine can lead to clitoral or vulvar symptoms, just like sciatica pain that shoots down the leg is related to issues in the spine,” Dr. Krapf says.
Dr. Krapf was excited to read of a new discovery: Dr. Krapf and other doctors are hopeful that the attention to the clitoris will spark more interest and comprehensive education among people in their field. They also hope it will empower patients to seek medical help if they are having issues with their clitoris.
“Female sexual health has historically been underfunded, especially compared with male sexual health, like erectile dysfunction,” Dr. Krapf says. “Optimizing vulvar and vaginal health is not only necessary for sexual well-being.”
Blair Peters, MD, a plastic surgeon who specializes in gender-affirming care, led the study, which was presented at the Sexual Medicine Society of North America conference in October. Dr. Peters says he hopes that the new information decreases stigma that the clitoris is not worthy of the same medical attention that other organs of the body receive.
When the clitoris doesn’t properly function, there can be harm to a person’s physical and mental health. Paying attention to discomfort in the clitoris, and seeking medical attention, can help catch and prevent some urinary and vaginal infections.
“The fact that it took until 2022 for someone to do this work speaks to how little attention the clitoris has received,” says Dr. Peters, an assistant professor of surgery at the Oregon Health and Science University School of Medicine, Portland.
What’s inside?
Dr. Peters and his colleagues completed the study by taking clitoral nerve tissue from seven adult transgender men who had received gender-affirming genital surgery. The tissues were dyed and magnified 1,000 times under a microscope so the researchers could count nerve fibers.
Dr. Peters says the finding is important because many surgeries take place in the groin region – like hip replacements, episiotomies during childbirth, and pelvic mesh procedures – and the revived attention to the clitoris may help health care providers know where nerves are so that injuries from medical mistakes are prevented.
“Nerves are at risk of damage if it’s not understood where they are at all times,” he says.
Dr. Peters hopes the new finding will help create new surgical techniques for nerve repair and offer insight for gender-affirming phalloplasty, which is the surgical construction of a penis often for transmasculine people.
Ownership of the body part
When it comes to the clitoris, no one type of doctor has specialized in the sex organ.
Urologists, gynecologists, plastic surgeons, and sex therapists all address potential problems that can arise with the clitoris and its surrounding body parts. But specialists like Dr. Krapf are few and far between.
It wasn’t until 2005 that Australian urologist Helen O’Connell found that the clitoris is filled with erectile and non-erectile tissues that are often hidden in anatomy drawings by fat and bone. And it wasn’t until the early 2000s that researchers began delving in earnest into the anatomy of the clitoris and how it functions.
And a 2018 study showed that if more doctors examined the clitoris, they could identify issues like adhesions or infections in the area, most of which can be treated without surgery.
A body part built for pleasure
Randi Levinson, a sex, marriage, and family therapist in Los Angeles, sees patients who have less sensation in the clitoris or pain while having sex, many of whom have recently given birth or are going through menopause.
Women often become embarrassed when they can’t orgasm, or have less sensation in the clitoris, but tend to avoid seeking medical advice, she says. Normalizing discussions about women’s pleasure and the vast anatomy that supports it may help some of her patients.
“The more normal it is to talk about and explore women’s pleasure, the less shame women will have when getting help when they aren’t experiencing pleasure,” Ms. Levinson says. “I have many ... clients who experience pain and discomfort with sex [after pregnancy] and no longer feel pleasure and are concerned that something is wrong with them.”
A version of this article first appeared on WebMD.com.
The patients of Jill Krapf, MD, are often too embarrassed to tell her about discomfort in their clitoris.
“I ask all of my patients about clitoral pain, and it is often the first time they have ever been asked about this,” says Dr. Krapf, the associate director of the Center for Vulvovaginal Disorders, a private clinic in Washington and New York.
Dr. Krapf is an ob.gyn. who specializes in female sexual pain that involves the pelvis, vagina, and vulva.
Many of the conditions Dr. Krapf treats don’t have outward symptoms that appear abnormal, but internally, there are damaged or irritated nerves that can result in hypersensitivity, unwanted arousal, or pain.
“Most recent research indicates that even a herniated disk or tear in the spine can lead to clitoral or vulvar symptoms, just like sciatica pain that shoots down the leg is related to issues in the spine,” Dr. Krapf says.
Dr. Krapf was excited to read of a new discovery: Dr. Krapf and other doctors are hopeful that the attention to the clitoris will spark more interest and comprehensive education among people in their field. They also hope it will empower patients to seek medical help if they are having issues with their clitoris.
“Female sexual health has historically been underfunded, especially compared with male sexual health, like erectile dysfunction,” Dr. Krapf says. “Optimizing vulvar and vaginal health is not only necessary for sexual well-being.”
Blair Peters, MD, a plastic surgeon who specializes in gender-affirming care, led the study, which was presented at the Sexual Medicine Society of North America conference in October. Dr. Peters says he hopes that the new information decreases stigma that the clitoris is not worthy of the same medical attention that other organs of the body receive.
When the clitoris doesn’t properly function, there can be harm to a person’s physical and mental health. Paying attention to discomfort in the clitoris, and seeking medical attention, can help catch and prevent some urinary and vaginal infections.
“The fact that it took until 2022 for someone to do this work speaks to how little attention the clitoris has received,” says Dr. Peters, an assistant professor of surgery at the Oregon Health and Science University School of Medicine, Portland.
What’s inside?
Dr. Peters and his colleagues completed the study by taking clitoral nerve tissue from seven adult transgender men who had received gender-affirming genital surgery. The tissues were dyed and magnified 1,000 times under a microscope so the researchers could count nerve fibers.
Dr. Peters says the finding is important because many surgeries take place in the groin region – like hip replacements, episiotomies during childbirth, and pelvic mesh procedures – and the revived attention to the clitoris may help health care providers know where nerves are so that injuries from medical mistakes are prevented.
“Nerves are at risk of damage if it’s not understood where they are at all times,” he says.
Dr. Peters hopes the new finding will help create new surgical techniques for nerve repair and offer insight for gender-affirming phalloplasty, which is the surgical construction of a penis often for transmasculine people.
Ownership of the body part
When it comes to the clitoris, no one type of doctor has specialized in the sex organ.
Urologists, gynecologists, plastic surgeons, and sex therapists all address potential problems that can arise with the clitoris and its surrounding body parts. But specialists like Dr. Krapf are few and far between.
It wasn’t until 2005 that Australian urologist Helen O’Connell found that the clitoris is filled with erectile and non-erectile tissues that are often hidden in anatomy drawings by fat and bone. And it wasn’t until the early 2000s that researchers began delving in earnest into the anatomy of the clitoris and how it functions.
And a 2018 study showed that if more doctors examined the clitoris, they could identify issues like adhesions or infections in the area, most of which can be treated without surgery.
A body part built for pleasure
Randi Levinson, a sex, marriage, and family therapist in Los Angeles, sees patients who have less sensation in the clitoris or pain while having sex, many of whom have recently given birth or are going through menopause.
Women often become embarrassed when they can’t orgasm, or have less sensation in the clitoris, but tend to avoid seeking medical advice, she says. Normalizing discussions about women’s pleasure and the vast anatomy that supports it may help some of her patients.
“The more normal it is to talk about and explore women’s pleasure, the less shame women will have when getting help when they aren’t experiencing pleasure,” Ms. Levinson says. “I have many ... clients who experience pain and discomfort with sex [after pregnancy] and no longer feel pleasure and are concerned that something is wrong with them.”
A version of this article first appeared on WebMD.com.
The patients of Jill Krapf, MD, are often too embarrassed to tell her about discomfort in their clitoris.
“I ask all of my patients about clitoral pain, and it is often the first time they have ever been asked about this,” says Dr. Krapf, the associate director of the Center for Vulvovaginal Disorders, a private clinic in Washington and New York.
Dr. Krapf is an ob.gyn. who specializes in female sexual pain that involves the pelvis, vagina, and vulva.
Many of the conditions Dr. Krapf treats don’t have outward symptoms that appear abnormal, but internally, there are damaged or irritated nerves that can result in hypersensitivity, unwanted arousal, or pain.
“Most recent research indicates that even a herniated disk or tear in the spine can lead to clitoral or vulvar symptoms, just like sciatica pain that shoots down the leg is related to issues in the spine,” Dr. Krapf says.
Dr. Krapf was excited to read of a new discovery: Dr. Krapf and other doctors are hopeful that the attention to the clitoris will spark more interest and comprehensive education among people in their field. They also hope it will empower patients to seek medical help if they are having issues with their clitoris.
“Female sexual health has historically been underfunded, especially compared with male sexual health, like erectile dysfunction,” Dr. Krapf says. “Optimizing vulvar and vaginal health is not only necessary for sexual well-being.”
Blair Peters, MD, a plastic surgeon who specializes in gender-affirming care, led the study, which was presented at the Sexual Medicine Society of North America conference in October. Dr. Peters says he hopes that the new information decreases stigma that the clitoris is not worthy of the same medical attention that other organs of the body receive.
When the clitoris doesn’t properly function, there can be harm to a person’s physical and mental health. Paying attention to discomfort in the clitoris, and seeking medical attention, can help catch and prevent some urinary and vaginal infections.
“The fact that it took until 2022 for someone to do this work speaks to how little attention the clitoris has received,” says Dr. Peters, an assistant professor of surgery at the Oregon Health and Science University School of Medicine, Portland.
What’s inside?
Dr. Peters and his colleagues completed the study by taking clitoral nerve tissue from seven adult transgender men who had received gender-affirming genital surgery. The tissues were dyed and magnified 1,000 times under a microscope so the researchers could count nerve fibers.
Dr. Peters says the finding is important because many surgeries take place in the groin region – like hip replacements, episiotomies during childbirth, and pelvic mesh procedures – and the revived attention to the clitoris may help health care providers know where nerves are so that injuries from medical mistakes are prevented.
“Nerves are at risk of damage if it’s not understood where they are at all times,” he says.
Dr. Peters hopes the new finding will help create new surgical techniques for nerve repair and offer insight for gender-affirming phalloplasty, which is the surgical construction of a penis often for transmasculine people.
Ownership of the body part
When it comes to the clitoris, no one type of doctor has specialized in the sex organ.
Urologists, gynecologists, plastic surgeons, and sex therapists all address potential problems that can arise with the clitoris and its surrounding body parts. But specialists like Dr. Krapf are few and far between.
It wasn’t until 2005 that Australian urologist Helen O’Connell found that the clitoris is filled with erectile and non-erectile tissues that are often hidden in anatomy drawings by fat and bone. And it wasn’t until the early 2000s that researchers began delving in earnest into the anatomy of the clitoris and how it functions.
And a 2018 study showed that if more doctors examined the clitoris, they could identify issues like adhesions or infections in the area, most of which can be treated without surgery.
A body part built for pleasure
Randi Levinson, a sex, marriage, and family therapist in Los Angeles, sees patients who have less sensation in the clitoris or pain while having sex, many of whom have recently given birth or are going through menopause.
Women often become embarrassed when they can’t orgasm, or have less sensation in the clitoris, but tend to avoid seeking medical advice, she says. Normalizing discussions about women’s pleasure and the vast anatomy that supports it may help some of her patients.
“The more normal it is to talk about and explore women’s pleasure, the less shame women will have when getting help when they aren’t experiencing pleasure,” Ms. Levinson says. “I have many ... clients who experience pain and discomfort with sex [after pregnancy] and no longer feel pleasure and are concerned that something is wrong with them.”
A version of this article first appeared on WebMD.com.
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
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.
FROM OBSTETRICS & GYNECOLOGY
Giving birth may permanently alter a mother’s bones
Female primates who had been pregnant showed lower levels of calcium, magnesium, and phosphorous in their bones, revealing for the first time new ways that females are changed by pregnancy and breastfeeding, according to a study published by PLOS One.
“Our findings provide additional evidence of the profound impact that reproduction has on the female organism, further demonstrating that the skeleton is not a static organ but a dynamic one that changes with life events,” said lead author and New York University doctoral student Paola Cerrito in a news release.
The study evaluated the bones of rhesus macaques, also known as rhesus monkeys, which share 93% of genes with humans, according to the National Primate Research Centers. They have been used in research that paved the way for many medical breakthroughs such as treatments for HIV/AIDS; they’re also used in Alzheimer’s research.
Menopause has long been known to impact bone health, which is tied to calcium and phosphorous levels. This latest research does not address how bone health is affected by pregnancy and lactation but further points to the everchanging state of bones based on life events.
“Our research shows that even before the cessation of fertility, the skeleton responds dynamically to changes in reproductive status,” Ms. Cerrito said. “Moreover, these findings reaffirm the significant impact giving birth has on a female organism – quite simply, evidence of reproduction is ‘written in the bones’ for life.”
A version of this article first appeared on WebMD.com.
Female primates who had been pregnant showed lower levels of calcium, magnesium, and phosphorous in their bones, revealing for the first time new ways that females are changed by pregnancy and breastfeeding, according to a study published by PLOS One.
“Our findings provide additional evidence of the profound impact that reproduction has on the female organism, further demonstrating that the skeleton is not a static organ but a dynamic one that changes with life events,” said lead author and New York University doctoral student Paola Cerrito in a news release.
The study evaluated the bones of rhesus macaques, also known as rhesus monkeys, which share 93% of genes with humans, according to the National Primate Research Centers. They have been used in research that paved the way for many medical breakthroughs such as treatments for HIV/AIDS; they’re also used in Alzheimer’s research.
Menopause has long been known to impact bone health, which is tied to calcium and phosphorous levels. This latest research does not address how bone health is affected by pregnancy and lactation but further points to the everchanging state of bones based on life events.
“Our research shows that even before the cessation of fertility, the skeleton responds dynamically to changes in reproductive status,” Ms. Cerrito said. “Moreover, these findings reaffirm the significant impact giving birth has on a female organism – quite simply, evidence of reproduction is ‘written in the bones’ for life.”
A version of this article first appeared on WebMD.com.
Female primates who had been pregnant showed lower levels of calcium, magnesium, and phosphorous in their bones, revealing for the first time new ways that females are changed by pregnancy and breastfeeding, according to a study published by PLOS One.
“Our findings provide additional evidence of the profound impact that reproduction has on the female organism, further demonstrating that the skeleton is not a static organ but a dynamic one that changes with life events,” said lead author and New York University doctoral student Paola Cerrito in a news release.
The study evaluated the bones of rhesus macaques, also known as rhesus monkeys, which share 93% of genes with humans, according to the National Primate Research Centers. They have been used in research that paved the way for many medical breakthroughs such as treatments for HIV/AIDS; they’re also used in Alzheimer’s research.
Menopause has long been known to impact bone health, which is tied to calcium and phosphorous levels. This latest research does not address how bone health is affected by pregnancy and lactation but further points to the everchanging state of bones based on life events.
“Our research shows that even before the cessation of fertility, the skeleton responds dynamically to changes in reproductive status,” Ms. Cerrito said. “Moreover, these findings reaffirm the significant impact giving birth has on a female organism – quite simply, evidence of reproduction is ‘written in the bones’ for life.”
A version of this article first appeared on WebMD.com.
FROM PLOS ONE
Sacral nerve stimulation may aid female sexual dysfunction
Sacral nerve stimulation (SNS) is a therapeutic procedure that could be used to help women with sexual dysfunction. However, the benefits of this method in this indication should still be reviewed in high-quality studies with sexual function as the primary endpoint, Erik Allemeyer, MD, PhD, a proctologist at the Niels Stensen Clinics in Georgsmarienhütte, Germany, and colleagues wrote in a recent journal article.
The World Health Organization defines sexual health as physical, emotional, mental, and social well-being in relation to sexuality. There are extensive investigations that verify the considerable importance of sexual function on a person’s quality of life. It therefore follows that therapy may be required if an individual is experiencing sexual dysfunction.
According to the authors, there are diverse data on the frequency of sexual dysfunction in women, in part because of heterogeneous definitions. The prevalence ranges between 26% and 91%. The estimated prevalence of orgasm difficulties in particular ranges from 16% to 25%. Sexual dysfunction can therefore be said to be a clinically significant problem.
It was recently discovered that SNS, which has only been used for other conditions so far, could also be an option for women with sexual dysfunction. According to Dr. Allemeyer and coauthors, SNS was first described in 1988 as a therapeutic alternative for patients with neurogenic bladder and has been approved in Europe since 1994. As a minimally invasive therapy for urge incontinence, idiopathic pelvic pain, and for nonobstructive urinary retention, SNS can now be used to treat a wide spectrum of conditions in urology and urogynecology. After the successful stimulation treatment of fecal incontinence was first described in 1995, the procedure has also been used in coloproctology.
Tested before implantation
In SNS, sacral nerve roots (S3 and S4) are permanently stimulated via a percutaneously implanted electrode. At first, the effect is reviewed using a test electrode and an external impulse generator over a period of a few weeks. Only if the test stimulation significantly alleviates symptoms can the indication for full implantation be issued, wrote the authors.
The positive effects on sexual function could be seen, even in the early years of stimulation therapy, when it was used for urinary and fecal incontinence as well as for idiopathic pelvic pain, they added. They have now summarized and discussed the current state of research on the potential effects of SNS on women’s sexual function in a literature review.
Systematic study analysis
To do this, they analyzed 16 studies, which included a total of 662 women, that reviewed the effect of SNS on sexual function when the treatment was being used in other indications. The overwhelming majority of data relates to urologic indications for SNS (such as overactive bladder, chronic retention, and idiopathic pelvic pain). In contrast, the SNS indication was rarely issued for fecal incontinence (9.1% of SNS indications or 61 patients). The most often used tool to assess the effect is the validated Female Sexual Function Index. The indicators covered in this index are “desire,” “arousal,” “lubrication,” “orgasm,” and “satisfaction.”
According to Dr. Allemeyer and coauthors, the analysis revealed evidence of significantly improved sexual function. It was unclear, however, whether this improvement was a primary or secondary effect of the SNS. All the original works and reviews expressly indicated that there was no proof of a primary effect of SNS on sexual function.
The mode of action of SNS and the immediate anatomic and physiologic link between the functions of urination, urinary incontinence, pelvic pain, fecal incontinence, and sexual function suggest a possible primary effect of SNS on sexual function, wrote the authors. However, no investigations use sexual function as the primary outcome parameter of SNS. This outcome should be reviewed in high-quality studies with sexual function as the primary endpoint.
An experimental therapy
According to Dr. Allemeyer and colleagues, two practical conclusions can be drawn from the study data available to date:
A possible primary effect of SNS on sexual function should be reviewed in high-quality, prospective studies that include detailed analyses of the different aspects of sexual dysfunction in both sexes.
An offer for trial-based SNS for sexual dysfunction should be made only at experienced sites with a multidisciplinary team of sex therapists and medical specialists and only after available therapy options have been exhausted and initially only within systematic studies.
This article was translated from Univadis Germany and a version appeared on Medscape.com.
Sacral nerve stimulation (SNS) is a therapeutic procedure that could be used to help women with sexual dysfunction. However, the benefits of this method in this indication should still be reviewed in high-quality studies with sexual function as the primary endpoint, Erik Allemeyer, MD, PhD, a proctologist at the Niels Stensen Clinics in Georgsmarienhütte, Germany, and colleagues wrote in a recent journal article.
The World Health Organization defines sexual health as physical, emotional, mental, and social well-being in relation to sexuality. There are extensive investigations that verify the considerable importance of sexual function on a person’s quality of life. It therefore follows that therapy may be required if an individual is experiencing sexual dysfunction.
According to the authors, there are diverse data on the frequency of sexual dysfunction in women, in part because of heterogeneous definitions. The prevalence ranges between 26% and 91%. The estimated prevalence of orgasm difficulties in particular ranges from 16% to 25%. Sexual dysfunction can therefore be said to be a clinically significant problem.
It was recently discovered that SNS, which has only been used for other conditions so far, could also be an option for women with sexual dysfunction. According to Dr. Allemeyer and coauthors, SNS was first described in 1988 as a therapeutic alternative for patients with neurogenic bladder and has been approved in Europe since 1994. As a minimally invasive therapy for urge incontinence, idiopathic pelvic pain, and for nonobstructive urinary retention, SNS can now be used to treat a wide spectrum of conditions in urology and urogynecology. After the successful stimulation treatment of fecal incontinence was first described in 1995, the procedure has also been used in coloproctology.
Tested before implantation
In SNS, sacral nerve roots (S3 and S4) are permanently stimulated via a percutaneously implanted electrode. At first, the effect is reviewed using a test electrode and an external impulse generator over a period of a few weeks. Only if the test stimulation significantly alleviates symptoms can the indication for full implantation be issued, wrote the authors.
The positive effects on sexual function could be seen, even in the early years of stimulation therapy, when it was used for urinary and fecal incontinence as well as for idiopathic pelvic pain, they added. They have now summarized and discussed the current state of research on the potential effects of SNS on women’s sexual function in a literature review.
Systematic study analysis
To do this, they analyzed 16 studies, which included a total of 662 women, that reviewed the effect of SNS on sexual function when the treatment was being used in other indications. The overwhelming majority of data relates to urologic indications for SNS (such as overactive bladder, chronic retention, and idiopathic pelvic pain). In contrast, the SNS indication was rarely issued for fecal incontinence (9.1% of SNS indications or 61 patients). The most often used tool to assess the effect is the validated Female Sexual Function Index. The indicators covered in this index are “desire,” “arousal,” “lubrication,” “orgasm,” and “satisfaction.”
According to Dr. Allemeyer and coauthors, the analysis revealed evidence of significantly improved sexual function. It was unclear, however, whether this improvement was a primary or secondary effect of the SNS. All the original works and reviews expressly indicated that there was no proof of a primary effect of SNS on sexual function.
The mode of action of SNS and the immediate anatomic and physiologic link between the functions of urination, urinary incontinence, pelvic pain, fecal incontinence, and sexual function suggest a possible primary effect of SNS on sexual function, wrote the authors. However, no investigations use sexual function as the primary outcome parameter of SNS. This outcome should be reviewed in high-quality studies with sexual function as the primary endpoint.
An experimental therapy
According to Dr. Allemeyer and colleagues, two practical conclusions can be drawn from the study data available to date:
A possible primary effect of SNS on sexual function should be reviewed in high-quality, prospective studies that include detailed analyses of the different aspects of sexual dysfunction in both sexes.
An offer for trial-based SNS for sexual dysfunction should be made only at experienced sites with a multidisciplinary team of sex therapists and medical specialists and only after available therapy options have been exhausted and initially only within systematic studies.
This article was translated from Univadis Germany and a version appeared on Medscape.com.
Sacral nerve stimulation (SNS) is a therapeutic procedure that could be used to help women with sexual dysfunction. However, the benefits of this method in this indication should still be reviewed in high-quality studies with sexual function as the primary endpoint, Erik Allemeyer, MD, PhD, a proctologist at the Niels Stensen Clinics in Georgsmarienhütte, Germany, and colleagues wrote in a recent journal article.
The World Health Organization defines sexual health as physical, emotional, mental, and social well-being in relation to sexuality. There are extensive investigations that verify the considerable importance of sexual function on a person’s quality of life. It therefore follows that therapy may be required if an individual is experiencing sexual dysfunction.
According to the authors, there are diverse data on the frequency of sexual dysfunction in women, in part because of heterogeneous definitions. The prevalence ranges between 26% and 91%. The estimated prevalence of orgasm difficulties in particular ranges from 16% to 25%. Sexual dysfunction can therefore be said to be a clinically significant problem.
It was recently discovered that SNS, which has only been used for other conditions so far, could also be an option for women with sexual dysfunction. According to Dr. Allemeyer and coauthors, SNS was first described in 1988 as a therapeutic alternative for patients with neurogenic bladder and has been approved in Europe since 1994. As a minimally invasive therapy for urge incontinence, idiopathic pelvic pain, and for nonobstructive urinary retention, SNS can now be used to treat a wide spectrum of conditions in urology and urogynecology. After the successful stimulation treatment of fecal incontinence was first described in 1995, the procedure has also been used in coloproctology.
Tested before implantation
In SNS, sacral nerve roots (S3 and S4) are permanently stimulated via a percutaneously implanted electrode. At first, the effect is reviewed using a test electrode and an external impulse generator over a period of a few weeks. Only if the test stimulation significantly alleviates symptoms can the indication for full implantation be issued, wrote the authors.
The positive effects on sexual function could be seen, even in the early years of stimulation therapy, when it was used for urinary and fecal incontinence as well as for idiopathic pelvic pain, they added. They have now summarized and discussed the current state of research on the potential effects of SNS on women’s sexual function in a literature review.
Systematic study analysis
To do this, they analyzed 16 studies, which included a total of 662 women, that reviewed the effect of SNS on sexual function when the treatment was being used in other indications. The overwhelming majority of data relates to urologic indications for SNS (such as overactive bladder, chronic retention, and idiopathic pelvic pain). In contrast, the SNS indication was rarely issued for fecal incontinence (9.1% of SNS indications or 61 patients). The most often used tool to assess the effect is the validated Female Sexual Function Index. The indicators covered in this index are “desire,” “arousal,” “lubrication,” “orgasm,” and “satisfaction.”
According to Dr. Allemeyer and coauthors, the analysis revealed evidence of significantly improved sexual function. It was unclear, however, whether this improvement was a primary or secondary effect of the SNS. All the original works and reviews expressly indicated that there was no proof of a primary effect of SNS on sexual function.
The mode of action of SNS and the immediate anatomic and physiologic link between the functions of urination, urinary incontinence, pelvic pain, fecal incontinence, and sexual function suggest a possible primary effect of SNS on sexual function, wrote the authors. However, no investigations use sexual function as the primary outcome parameter of SNS. This outcome should be reviewed in high-quality studies with sexual function as the primary endpoint.
An experimental therapy
According to Dr. Allemeyer and colleagues, two practical conclusions can be drawn from the study data available to date:
A possible primary effect of SNS on sexual function should be reviewed in high-quality, prospective studies that include detailed analyses of the different aspects of sexual dysfunction in both sexes.
An offer for trial-based SNS for sexual dysfunction should be made only at experienced sites with a multidisciplinary team of sex therapists and medical specialists and only after available therapy options have been exhausted and initially only within systematic studies.
This article was translated from Univadis Germany and a version appeared on Medscape.com.
FROM DIE GYNÄKOLOGIE
Promising new antibiotic emerges for treating UTIs
A new antibiotic for urinary tract infections is heading toward government approval.
It would be the first new treatment in 20 years for UTIs, which affect more than half of women at least sometime in their lives, according to data compiled by the Department of Health and Human Services.
Called Gepotidacin, the antibiotic’s trial has halted enrollment early due to excellent effectiveness and safety results thus far, drugmaker GSK announced in a press release Nov. 3. GSK will seek approval and peer-reviewed publication early next year.
There is a need for new antibiotics such as this because of increasing antibiotic resistance. Antibiotic resistance to bacteria has become so prevalent that the World Health Organization recently began publishing a list of bacteria that pose the greatest public health threats.
“It’s definitely a big deal,” Cindy Liu, MD, MPH, PhD, of the Antibiotic Resistance Action Center at George Washington University, told CNN.
However, antibiotics are not a particularly profitable type of drug, The Wall Street Journal reported. The newspaper noted that they need to be used sparingly to limit resistance, and the cheapest option is usually prescribed. Some small companies that make antibiotics have even gone bankrupt recently, the Journal noted.
The U.S. government has invested in GSK’s development of Gepotidacin. The company predicts the drug could be a “blockbuster” and earn more than $1 billion due to UTI resistance to other drugs, the Journal reported.
“I think it will be really interesting and important to the field to see both how the drug companies sort of market this product and sort of how it does,” Dr. Liu said.
A version of this article first appeared on Medscape.com.
A new antibiotic for urinary tract infections is heading toward government approval.
It would be the first new treatment in 20 years for UTIs, which affect more than half of women at least sometime in their lives, according to data compiled by the Department of Health and Human Services.
Called Gepotidacin, the antibiotic’s trial has halted enrollment early due to excellent effectiveness and safety results thus far, drugmaker GSK announced in a press release Nov. 3. GSK will seek approval and peer-reviewed publication early next year.
There is a need for new antibiotics such as this because of increasing antibiotic resistance. Antibiotic resistance to bacteria has become so prevalent that the World Health Organization recently began publishing a list of bacteria that pose the greatest public health threats.
“It’s definitely a big deal,” Cindy Liu, MD, MPH, PhD, of the Antibiotic Resistance Action Center at George Washington University, told CNN.
However, antibiotics are not a particularly profitable type of drug, The Wall Street Journal reported. The newspaper noted that they need to be used sparingly to limit resistance, and the cheapest option is usually prescribed. Some small companies that make antibiotics have even gone bankrupt recently, the Journal noted.
The U.S. government has invested in GSK’s development of Gepotidacin. The company predicts the drug could be a “blockbuster” and earn more than $1 billion due to UTI resistance to other drugs, the Journal reported.
“I think it will be really interesting and important to the field to see both how the drug companies sort of market this product and sort of how it does,” Dr. Liu said.
A version of this article first appeared on Medscape.com.
A new antibiotic for urinary tract infections is heading toward government approval.
It would be the first new treatment in 20 years for UTIs, which affect more than half of women at least sometime in their lives, according to data compiled by the Department of Health and Human Services.
Called Gepotidacin, the antibiotic’s trial has halted enrollment early due to excellent effectiveness and safety results thus far, drugmaker GSK announced in a press release Nov. 3. GSK will seek approval and peer-reviewed publication early next year.
There is a need for new antibiotics such as this because of increasing antibiotic resistance. Antibiotic resistance to bacteria has become so prevalent that the World Health Organization recently began publishing a list of bacteria that pose the greatest public health threats.
“It’s definitely a big deal,” Cindy Liu, MD, MPH, PhD, of the Antibiotic Resistance Action Center at George Washington University, told CNN.
However, antibiotics are not a particularly profitable type of drug, The Wall Street Journal reported. The newspaper noted that they need to be used sparingly to limit resistance, and the cheapest option is usually prescribed. Some small companies that make antibiotics have even gone bankrupt recently, the Journal noted.
The U.S. government has invested in GSK’s development of Gepotidacin. The company predicts the drug could be a “blockbuster” and earn more than $1 billion due to UTI resistance to other drugs, the Journal reported.
“I think it will be really interesting and important to the field to see both how the drug companies sort of market this product and sort of how it does,” Dr. Liu said.
A version of this article first appeared on Medscape.com.
HPV vaccine effectiveness dependent on age at receipt
The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.
“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.
“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.
The research letter was published online in JAMA Network Open.
National sample evaluated
Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).
They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.
In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.
In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).
In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.
Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.
Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
Vaccination rates increasing
Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.
Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.
At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.
“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.
“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.
Dr. Edgman and Dr. Perkins report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.
“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.
“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.
The research letter was published online in JAMA Network Open.
National sample evaluated
Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).
They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.
In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.
In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).
In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.
Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.
Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
Vaccination rates increasing
Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.
Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.
At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.
“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.
“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.
Dr. Edgman and Dr. Perkins report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.
“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.
“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.
The research letter was published online in JAMA Network Open.
National sample evaluated
Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).
They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.
In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.
In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).
In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.
Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.
Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
Vaccination rates increasing
Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.
Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.
At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.
“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.
“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.
Dr. Edgman and Dr. Perkins report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Post ‘Roe,’ contraceptive failures carry bigger stakes
Birth control options have improved over the decades. Oral contraceptives are now safer, with fewer side effects. Intrauterine devices can prevent pregnancy 99.6% of the time. But no prescription drug or medical device works flawlessly, and people’s use of contraception is inexact.
“No one walks into my office and says, ‘I plan on missing a pill,’ ” said obstetrician-gynecologist Mitchell Creinin, MD.
“There is no such thing as perfect use; we are all real-life users,” said Dr. Creinin, a professor at the University of California, Davis, who wrote a widely used textbook that details contraceptive failure rates.
Even when the odds of contraception failure are small, the number of incidents can add up quickly. More than 47 million women of reproductive age in the United States use contraception, and, depending on the birth control method, hundreds of thousands of unplanned pregnancies can occur each year. With most abortions outlawed in at least 13 states and legal battles underway in others, contraceptive failures now carry bigger stakes for tens of millions of Americans.
Researchers distinguish between the perfect use of birth control, when a method is used consistently and correctly every time, and typical use, when a method is used in real-life circumstances. No birth control, short of a complete female sterilization, has a 0.00% failure rate.
The failure rate for typical use of birth control pills is 7%. For every million women taking pills, 70,000 unplanned pregnancies could occur in a year. According to the most recent data available, more than 6.5 million women ages 15 to 49 use oral contraceptives, leading to about 460,000 unplanned pregnancies.
Even seemingly minuscule failure rates of IUDs and birth control implants can lead to surprises.
An intrauterine device releases a hormone that thickens the mucus on the cervix. Sperm hit the brick wall of mucus and are unable to pass through the barrier. Implants are matchstick-sized plastic rods placed under the skin, which send a steady, low dose of hormone into the body that also thickens the cervical mucus and prevents the ovaries from releasing an egg. But not always. The hormonal IUD and implants fail to prevent pregnancy 0.1%-0.4% of the time.
Some 4.8 million women use IUDs or implants in the U.S., leading to as many as 5,000 to 20,000 unplanned pregnancies a year.
“We’ve had women come through here for abortions who had an IUD, and they were the one in a thousand,” said Gordon Low, a nurse practitioner at the Planned Parenthood in Little Rock.
Abortion has been outlawed in Arkansas since the Supreme Court’s ruling on Dobbs v. Jackson Women’s Health Organization in late June. The only exception is when a patient’s death is considered imminent.
Those stakes are the new backdrop for couples making decisions about which form of contraception to choose or calculating the chances of pregnancy.
Another complication is the belief among many that contraceptives should work all the time, every time.
“In medicine, there is never anything that is 100%,” said Régine Sitruk-Ware, MD, a reproductive endocrinologist at the Population Council, a nonprofit research organization.
All sorts of factors interfere with contraceptive efficacy, said Dr. Sitruk-Ware. Certain medications for HIV and tuberculosis and the herbal supplement St. John’s wort can disrupt the liver’s processing of birth control pills. A medical provider might insert an IUD imprecisely into the uterus. Emergency contraception, including Plan B, is less effective in women weighing more than 165 pounds because the hormone in the medication is weight-dependent.
And life is hectic.
“You may have a delay in taking your next pill,” said Dr. Sitruk-Ware, or getting to the doctor to insert “your next vaginal ring.”
Using contraception consistently and correctly lessens the chance for a failure but Alina Salganicoff, KFF’s director of women’s health policy, said that for many people access to birth control is anything but dependable. Birth control pills are needed month after month, year after year, but “the vast majority of women can only get a one- to two-month supply,” she said.
Even vasectomies can fail.
During a vasectomy, the surgeon cuts the tube that carries sperm to the semen.
The procedure is one of the most effective methods of birth control – the failure rate is 0.15% – and avoids the side effects of hormonal birth control. But even after the vas deferens is cut, cells in the body can heal themselves, including after a vasectomy.
“If you get a cut on your finger, the skin covers it back up,” said Dr. Creinin. “Depending on how big the gap is and how the procedure is done, that tube may grow back together, and that’s one of the ways in which it fails.”
Researchers are testing reversible birth control methods for men, including a hormonal gel applied to the shoulders that suppresses sperm production. Among the 350 participants in the trial and their partners, so far zero pregnancies have occurred. It’s expected to take years for the new methods to reach the market and be available to consumers. Meanwhile, vasectomies and condoms remain the only contraception available for men, who remain fertile for much of their lives.
At 13%, the typical-use failure rate of condoms is among the highest of birth control methods. Condoms play a vital role in stopping the spread of HIV and other sexually transmitted infections, but they are often misused or tear. The typical-use failure rate means that for 1 million couples using condoms, 130,000 unplanned pregnancies could occur in one year.
Navigating the failure rates of birth control medicines and medical devices is just one aspect of preventing pregnancy. Ensuring a male sexual partner uses a condom can require negotiation or persuasion skills that can be difficult to navigate, said Jennifer Evans, an assistant teaching professor and health education specialist at Northeastern University.
Historically, women have had little to no say in whether to engage in sexual intercourse and limited autonomy over their bodies, complicating sexual-negotiation skills today, said Ms. Evans.
Part of Ms. Evans’ research focuses on men who coerce women into sex without a condom. One tactic, known as “stealthing,” is when a man puts on a condom but then removes it either before or during sexual intercourse without the other person’s knowledge or consent.
“In a lot of these stealthing cases women don’t necessarily know the condom has been used improperly,” said Ms. Evans. “It means they can’t engage in any kind of preventative behaviors like taking a Plan B or even going and getting an abortion in a timely manner.”
Ms. Evans has found that heterosexual men who engage in stealthing often have hostile attitudes toward women. They report that sex without a condom feels better or say they do it “for the thrill of engaging in a behavior they know is not OK,” she said. Ms. Evans cautions women who suspect a sexual partner will not use a condom correctly to not have sex with that person.
“The consequences were already severe before,” said Ms. Evans, “but now that Roe v. Wade has been overturned, they’re even more right now.”
This story is a collaboration between KHN and Science Friday. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Birth control options have improved over the decades. Oral contraceptives are now safer, with fewer side effects. Intrauterine devices can prevent pregnancy 99.6% of the time. But no prescription drug or medical device works flawlessly, and people’s use of contraception is inexact.
“No one walks into my office and says, ‘I plan on missing a pill,’ ” said obstetrician-gynecologist Mitchell Creinin, MD.
“There is no such thing as perfect use; we are all real-life users,” said Dr. Creinin, a professor at the University of California, Davis, who wrote a widely used textbook that details contraceptive failure rates.
Even when the odds of contraception failure are small, the number of incidents can add up quickly. More than 47 million women of reproductive age in the United States use contraception, and, depending on the birth control method, hundreds of thousands of unplanned pregnancies can occur each year. With most abortions outlawed in at least 13 states and legal battles underway in others, contraceptive failures now carry bigger stakes for tens of millions of Americans.
Researchers distinguish between the perfect use of birth control, when a method is used consistently and correctly every time, and typical use, when a method is used in real-life circumstances. No birth control, short of a complete female sterilization, has a 0.00% failure rate.
The failure rate for typical use of birth control pills is 7%. For every million women taking pills, 70,000 unplanned pregnancies could occur in a year. According to the most recent data available, more than 6.5 million women ages 15 to 49 use oral contraceptives, leading to about 460,000 unplanned pregnancies.
Even seemingly minuscule failure rates of IUDs and birth control implants can lead to surprises.
An intrauterine device releases a hormone that thickens the mucus on the cervix. Sperm hit the brick wall of mucus and are unable to pass through the barrier. Implants are matchstick-sized plastic rods placed under the skin, which send a steady, low dose of hormone into the body that also thickens the cervical mucus and prevents the ovaries from releasing an egg. But not always. The hormonal IUD and implants fail to prevent pregnancy 0.1%-0.4% of the time.
Some 4.8 million women use IUDs or implants in the U.S., leading to as many as 5,000 to 20,000 unplanned pregnancies a year.
“We’ve had women come through here for abortions who had an IUD, and they were the one in a thousand,” said Gordon Low, a nurse practitioner at the Planned Parenthood in Little Rock.
Abortion has been outlawed in Arkansas since the Supreme Court’s ruling on Dobbs v. Jackson Women’s Health Organization in late June. The only exception is when a patient’s death is considered imminent.
Those stakes are the new backdrop for couples making decisions about which form of contraception to choose or calculating the chances of pregnancy.
Another complication is the belief among many that contraceptives should work all the time, every time.
“In medicine, there is never anything that is 100%,” said Régine Sitruk-Ware, MD, a reproductive endocrinologist at the Population Council, a nonprofit research organization.
All sorts of factors interfere with contraceptive efficacy, said Dr. Sitruk-Ware. Certain medications for HIV and tuberculosis and the herbal supplement St. John’s wort can disrupt the liver’s processing of birth control pills. A medical provider might insert an IUD imprecisely into the uterus. Emergency contraception, including Plan B, is less effective in women weighing more than 165 pounds because the hormone in the medication is weight-dependent.
And life is hectic.
“You may have a delay in taking your next pill,” said Dr. Sitruk-Ware, or getting to the doctor to insert “your next vaginal ring.”
Using contraception consistently and correctly lessens the chance for a failure but Alina Salganicoff, KFF’s director of women’s health policy, said that for many people access to birth control is anything but dependable. Birth control pills are needed month after month, year after year, but “the vast majority of women can only get a one- to two-month supply,” she said.
Even vasectomies can fail.
During a vasectomy, the surgeon cuts the tube that carries sperm to the semen.
The procedure is one of the most effective methods of birth control – the failure rate is 0.15% – and avoids the side effects of hormonal birth control. But even after the vas deferens is cut, cells in the body can heal themselves, including after a vasectomy.
“If you get a cut on your finger, the skin covers it back up,” said Dr. Creinin. “Depending on how big the gap is and how the procedure is done, that tube may grow back together, and that’s one of the ways in which it fails.”
Researchers are testing reversible birth control methods for men, including a hormonal gel applied to the shoulders that suppresses sperm production. Among the 350 participants in the trial and their partners, so far zero pregnancies have occurred. It’s expected to take years for the new methods to reach the market and be available to consumers. Meanwhile, vasectomies and condoms remain the only contraception available for men, who remain fertile for much of their lives.
At 13%, the typical-use failure rate of condoms is among the highest of birth control methods. Condoms play a vital role in stopping the spread of HIV and other sexually transmitted infections, but they are often misused or tear. The typical-use failure rate means that for 1 million couples using condoms, 130,000 unplanned pregnancies could occur in one year.
Navigating the failure rates of birth control medicines and medical devices is just one aspect of preventing pregnancy. Ensuring a male sexual partner uses a condom can require negotiation or persuasion skills that can be difficult to navigate, said Jennifer Evans, an assistant teaching professor and health education specialist at Northeastern University.
Historically, women have had little to no say in whether to engage in sexual intercourse and limited autonomy over their bodies, complicating sexual-negotiation skills today, said Ms. Evans.
Part of Ms. Evans’ research focuses on men who coerce women into sex without a condom. One tactic, known as “stealthing,” is when a man puts on a condom but then removes it either before or during sexual intercourse without the other person’s knowledge or consent.
“In a lot of these stealthing cases women don’t necessarily know the condom has been used improperly,” said Ms. Evans. “It means they can’t engage in any kind of preventative behaviors like taking a Plan B or even going and getting an abortion in a timely manner.”
Ms. Evans has found that heterosexual men who engage in stealthing often have hostile attitudes toward women. They report that sex without a condom feels better or say they do it “for the thrill of engaging in a behavior they know is not OK,” she said. Ms. Evans cautions women who suspect a sexual partner will not use a condom correctly to not have sex with that person.
“The consequences were already severe before,” said Ms. Evans, “but now that Roe v. Wade has been overturned, they’re even more right now.”
This story is a collaboration between KHN and Science Friday. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Birth control options have improved over the decades. Oral contraceptives are now safer, with fewer side effects. Intrauterine devices can prevent pregnancy 99.6% of the time. But no prescription drug or medical device works flawlessly, and people’s use of contraception is inexact.
“No one walks into my office and says, ‘I plan on missing a pill,’ ” said obstetrician-gynecologist Mitchell Creinin, MD.
“There is no such thing as perfect use; we are all real-life users,” said Dr. Creinin, a professor at the University of California, Davis, who wrote a widely used textbook that details contraceptive failure rates.
Even when the odds of contraception failure are small, the number of incidents can add up quickly. More than 47 million women of reproductive age in the United States use contraception, and, depending on the birth control method, hundreds of thousands of unplanned pregnancies can occur each year. With most abortions outlawed in at least 13 states and legal battles underway in others, contraceptive failures now carry bigger stakes for tens of millions of Americans.
Researchers distinguish between the perfect use of birth control, when a method is used consistently and correctly every time, and typical use, when a method is used in real-life circumstances. No birth control, short of a complete female sterilization, has a 0.00% failure rate.
The failure rate for typical use of birth control pills is 7%. For every million women taking pills, 70,000 unplanned pregnancies could occur in a year. According to the most recent data available, more than 6.5 million women ages 15 to 49 use oral contraceptives, leading to about 460,000 unplanned pregnancies.
Even seemingly minuscule failure rates of IUDs and birth control implants can lead to surprises.
An intrauterine device releases a hormone that thickens the mucus on the cervix. Sperm hit the brick wall of mucus and are unable to pass through the barrier. Implants are matchstick-sized plastic rods placed under the skin, which send a steady, low dose of hormone into the body that also thickens the cervical mucus and prevents the ovaries from releasing an egg. But not always. The hormonal IUD and implants fail to prevent pregnancy 0.1%-0.4% of the time.
Some 4.8 million women use IUDs or implants in the U.S., leading to as many as 5,000 to 20,000 unplanned pregnancies a year.
“We’ve had women come through here for abortions who had an IUD, and they were the one in a thousand,” said Gordon Low, a nurse practitioner at the Planned Parenthood in Little Rock.
Abortion has been outlawed in Arkansas since the Supreme Court’s ruling on Dobbs v. Jackson Women’s Health Organization in late June. The only exception is when a patient’s death is considered imminent.
Those stakes are the new backdrop for couples making decisions about which form of contraception to choose or calculating the chances of pregnancy.
Another complication is the belief among many that contraceptives should work all the time, every time.
“In medicine, there is never anything that is 100%,” said Régine Sitruk-Ware, MD, a reproductive endocrinologist at the Population Council, a nonprofit research organization.
All sorts of factors interfere with contraceptive efficacy, said Dr. Sitruk-Ware. Certain medications for HIV and tuberculosis and the herbal supplement St. John’s wort can disrupt the liver’s processing of birth control pills. A medical provider might insert an IUD imprecisely into the uterus. Emergency contraception, including Plan B, is less effective in women weighing more than 165 pounds because the hormone in the medication is weight-dependent.
And life is hectic.
“You may have a delay in taking your next pill,” said Dr. Sitruk-Ware, or getting to the doctor to insert “your next vaginal ring.”
Using contraception consistently and correctly lessens the chance for a failure but Alina Salganicoff, KFF’s director of women’s health policy, said that for many people access to birth control is anything but dependable. Birth control pills are needed month after month, year after year, but “the vast majority of women can only get a one- to two-month supply,” she said.
Even vasectomies can fail.
During a vasectomy, the surgeon cuts the tube that carries sperm to the semen.
The procedure is one of the most effective methods of birth control – the failure rate is 0.15% – and avoids the side effects of hormonal birth control. But even after the vas deferens is cut, cells in the body can heal themselves, including after a vasectomy.
“If you get a cut on your finger, the skin covers it back up,” said Dr. Creinin. “Depending on how big the gap is and how the procedure is done, that tube may grow back together, and that’s one of the ways in which it fails.”
Researchers are testing reversible birth control methods for men, including a hormonal gel applied to the shoulders that suppresses sperm production. Among the 350 participants in the trial and their partners, so far zero pregnancies have occurred. It’s expected to take years for the new methods to reach the market and be available to consumers. Meanwhile, vasectomies and condoms remain the only contraception available for men, who remain fertile for much of their lives.
At 13%, the typical-use failure rate of condoms is among the highest of birth control methods. Condoms play a vital role in stopping the spread of HIV and other sexually transmitted infections, but they are often misused or tear. The typical-use failure rate means that for 1 million couples using condoms, 130,000 unplanned pregnancies could occur in one year.
Navigating the failure rates of birth control medicines and medical devices is just one aspect of preventing pregnancy. Ensuring a male sexual partner uses a condom can require negotiation or persuasion skills that can be difficult to navigate, said Jennifer Evans, an assistant teaching professor and health education specialist at Northeastern University.
Historically, women have had little to no say in whether to engage in sexual intercourse and limited autonomy over their bodies, complicating sexual-negotiation skills today, said Ms. Evans.
Part of Ms. Evans’ research focuses on men who coerce women into sex without a condom. One tactic, known as “stealthing,” is when a man puts on a condom but then removes it either before or during sexual intercourse without the other person’s knowledge or consent.
“In a lot of these stealthing cases women don’t necessarily know the condom has been used improperly,” said Ms. Evans. “It means they can’t engage in any kind of preventative behaviors like taking a Plan B or even going and getting an abortion in a timely manner.”
Ms. Evans has found that heterosexual men who engage in stealthing often have hostile attitudes toward women. They report that sex without a condom feels better or say they do it “for the thrill of engaging in a behavior they know is not OK,” she said. Ms. Evans cautions women who suspect a sexual partner will not use a condom correctly to not have sex with that person.
“The consequences were already severe before,” said Ms. Evans, “but now that Roe v. Wade has been overturned, they’re even more right now.”
This story is a collaboration between KHN and Science Friday. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.