User login
Delayed first contraception use raises unwanted pregnancy risk
Young women who delay starting contraception when they start sexual activity are at increased risk of unwanted pregnancy, according to data from a cross-sectional study of more than 26,000 women in the United States.
Unintended pregnancy in the United States is associated with delayed prenatal care, premature birth, and low birth weight and remains more common among African American and Hispanic women than among white women, and it also is more common among low-income women than among high income women, wrote Mara E. Murray Horwitz, MD, of Harvard Pilgrim Health Care Institute in Boston and her colleagues.
“Reducing unintended pregnancy and the associated socioeconomic disparities is a national public health priority,” they wrote.
In a study published in Pediatrics, the researchers reviewed data from four cycles of the National Survey of Family Growth between 2002 and 2015. They examined self-reported responses from 26,359 women aged 15-44 years with sexual debuts during 1970-2014, including the dates of sexual debut, initiation of contraceptives, and rates of unwanted pregnancy. Timely contraceptive initiation was defined as use within a month of starting sexual activity.
Overall, one in five women reported delayed initiation of contraception. This delay was significantly associated with an increased unwanted pregnancy risk within 3 months of starting sexual activity, compared with timely use of contraception (adjusted risk ratio, 3.7). The average age of sexual debut was 17 years.
When the researchers examined subgroups, they found that one in four respondents who were African American, Hispanic, or low income reported delayed contraceptive initiation.
No association with unwanted pregnancy was found between effective versus less effective contraception methods. Timely contraceptive use increased during the study period from less than 10% in the 1970s to more than 25% in the 2000s, but condoms accounted for most of this increase. Use of other methods including long-acting reversible and short-acting hormonal options was low, especially among African American, Hispanic, and low-income women, Dr. Murray Horwitz and her colleagues noted.
The study was limited by several factors including the use of self-reports, lack of data on the exact start of contraceptive initiation, and the lack of association between contraceptive method and unwanted pregnancy, the researchers noted. However, the findings suggest that clinicians can help by intervening with young patients and educating them about early adoption of pregnancy prevention strategies.
The study was funded by the National Institutes of Health; Dr. Murray Horwitz was supported by an award from the NIH and Harvard Pilgrim Health Care Institute. Another researcher received support from Harvard Pilgrim Health Care Institute to provide mentorship for the study. The remaining researcher had no relevant financial disclosures.
SOURCE: Murray Horwitz M et al. Pediatrics. 2019;143(2):e20182463.
Despite a declining teen birth rate in the last several decades, the United States has the highest teen birth rate among industrialized nations. While many factors play into this rate, we know that, in many European countries with low teen birth rates, adolescents often initiate contraceptive methods before their sexual debut. As we often tell teenagers, they can become pregnant the “first time,” which makes initiating contraception early – and preferably before sexual debut – an important strategy to preventing unplanned pregnancy.
This study identifies the trends over time in the initiation of contraception in relationship to sexual debut and examines its effects on unplanned teen pregnancy. Understanding these trends can help clinicians more effectively target teen pregnancy.
I was pleasantly surprised to see that rates of timely contraceptive initiation have increased since 1970. Sadly, this rise is largely because of condom use. Use of effective forms of contraception – especially long-acting reversible forms of contraception (LARC), such as the IUD or the etonogestrel rod – still remain low at the time of sexual debut. While we continue to encourage LARCs as first line for pregnancy prevention, many patients are not getting the message about these highly effective, safe methods. Unsurprisingly, there are significant differences based on race/ethnicity and socioeconomic status on timely initiation of contraceptive methods, especially highly effective methods. This supports prior research which has shown significant barriers in access to contraception to these groups, which leads to higher rates of unplanned pregnancies.
Dr. Kelly Curran, MD, specializes in adolescent medicine at the University of Oklahoma, Oklahoma City. She is a member of the Pediatric News editorial advisory board and was asked to comment on the study by Murray Horwitz et al. Dr. Curran had no relevant financial disclosures.
Despite a declining teen birth rate in the last several decades, the United States has the highest teen birth rate among industrialized nations. While many factors play into this rate, we know that, in many European countries with low teen birth rates, adolescents often initiate contraceptive methods before their sexual debut. As we often tell teenagers, they can become pregnant the “first time,” which makes initiating contraception early – and preferably before sexual debut – an important strategy to preventing unplanned pregnancy.
This study identifies the trends over time in the initiation of contraception in relationship to sexual debut and examines its effects on unplanned teen pregnancy. Understanding these trends can help clinicians more effectively target teen pregnancy.
I was pleasantly surprised to see that rates of timely contraceptive initiation have increased since 1970. Sadly, this rise is largely because of condom use. Use of effective forms of contraception – especially long-acting reversible forms of contraception (LARC), such as the IUD or the etonogestrel rod – still remain low at the time of sexual debut. While we continue to encourage LARCs as first line for pregnancy prevention, many patients are not getting the message about these highly effective, safe methods. Unsurprisingly, there are significant differences based on race/ethnicity and socioeconomic status on timely initiation of contraceptive methods, especially highly effective methods. This supports prior research which has shown significant barriers in access to contraception to these groups, which leads to higher rates of unplanned pregnancies.
Dr. Kelly Curran, MD, specializes in adolescent medicine at the University of Oklahoma, Oklahoma City. She is a member of the Pediatric News editorial advisory board and was asked to comment on the study by Murray Horwitz et al. Dr. Curran had no relevant financial disclosures.
Despite a declining teen birth rate in the last several decades, the United States has the highest teen birth rate among industrialized nations. While many factors play into this rate, we know that, in many European countries with low teen birth rates, adolescents often initiate contraceptive methods before their sexual debut. As we often tell teenagers, they can become pregnant the “first time,” which makes initiating contraception early – and preferably before sexual debut – an important strategy to preventing unplanned pregnancy.
This study identifies the trends over time in the initiation of contraception in relationship to sexual debut and examines its effects on unplanned teen pregnancy. Understanding these trends can help clinicians more effectively target teen pregnancy.
I was pleasantly surprised to see that rates of timely contraceptive initiation have increased since 1970. Sadly, this rise is largely because of condom use. Use of effective forms of contraception – especially long-acting reversible forms of contraception (LARC), such as the IUD or the etonogestrel rod – still remain low at the time of sexual debut. While we continue to encourage LARCs as first line for pregnancy prevention, many patients are not getting the message about these highly effective, safe methods. Unsurprisingly, there are significant differences based on race/ethnicity and socioeconomic status on timely initiation of contraceptive methods, especially highly effective methods. This supports prior research which has shown significant barriers in access to contraception to these groups, which leads to higher rates of unplanned pregnancies.
Dr. Kelly Curran, MD, specializes in adolescent medicine at the University of Oklahoma, Oklahoma City. She is a member of the Pediatric News editorial advisory board and was asked to comment on the study by Murray Horwitz et al. Dr. Curran had no relevant financial disclosures.
Young women who delay starting contraception when they start sexual activity are at increased risk of unwanted pregnancy, according to data from a cross-sectional study of more than 26,000 women in the United States.
Unintended pregnancy in the United States is associated with delayed prenatal care, premature birth, and low birth weight and remains more common among African American and Hispanic women than among white women, and it also is more common among low-income women than among high income women, wrote Mara E. Murray Horwitz, MD, of Harvard Pilgrim Health Care Institute in Boston and her colleagues.
“Reducing unintended pregnancy and the associated socioeconomic disparities is a national public health priority,” they wrote.
In a study published in Pediatrics, the researchers reviewed data from four cycles of the National Survey of Family Growth between 2002 and 2015. They examined self-reported responses from 26,359 women aged 15-44 years with sexual debuts during 1970-2014, including the dates of sexual debut, initiation of contraceptives, and rates of unwanted pregnancy. Timely contraceptive initiation was defined as use within a month of starting sexual activity.
Overall, one in five women reported delayed initiation of contraception. This delay was significantly associated with an increased unwanted pregnancy risk within 3 months of starting sexual activity, compared with timely use of contraception (adjusted risk ratio, 3.7). The average age of sexual debut was 17 years.
When the researchers examined subgroups, they found that one in four respondents who were African American, Hispanic, or low income reported delayed contraceptive initiation.
No association with unwanted pregnancy was found between effective versus less effective contraception methods. Timely contraceptive use increased during the study period from less than 10% in the 1970s to more than 25% in the 2000s, but condoms accounted for most of this increase. Use of other methods including long-acting reversible and short-acting hormonal options was low, especially among African American, Hispanic, and low-income women, Dr. Murray Horwitz and her colleagues noted.
The study was limited by several factors including the use of self-reports, lack of data on the exact start of contraceptive initiation, and the lack of association between contraceptive method and unwanted pregnancy, the researchers noted. However, the findings suggest that clinicians can help by intervening with young patients and educating them about early adoption of pregnancy prevention strategies.
The study was funded by the National Institutes of Health; Dr. Murray Horwitz was supported by an award from the NIH and Harvard Pilgrim Health Care Institute. Another researcher received support from Harvard Pilgrim Health Care Institute to provide mentorship for the study. The remaining researcher had no relevant financial disclosures.
SOURCE: Murray Horwitz M et al. Pediatrics. 2019;143(2):e20182463.
Young women who delay starting contraception when they start sexual activity are at increased risk of unwanted pregnancy, according to data from a cross-sectional study of more than 26,000 women in the United States.
Unintended pregnancy in the United States is associated with delayed prenatal care, premature birth, and low birth weight and remains more common among African American and Hispanic women than among white women, and it also is more common among low-income women than among high income women, wrote Mara E. Murray Horwitz, MD, of Harvard Pilgrim Health Care Institute in Boston and her colleagues.
“Reducing unintended pregnancy and the associated socioeconomic disparities is a national public health priority,” they wrote.
In a study published in Pediatrics, the researchers reviewed data from four cycles of the National Survey of Family Growth between 2002 and 2015. They examined self-reported responses from 26,359 women aged 15-44 years with sexual debuts during 1970-2014, including the dates of sexual debut, initiation of contraceptives, and rates of unwanted pregnancy. Timely contraceptive initiation was defined as use within a month of starting sexual activity.
Overall, one in five women reported delayed initiation of contraception. This delay was significantly associated with an increased unwanted pregnancy risk within 3 months of starting sexual activity, compared with timely use of contraception (adjusted risk ratio, 3.7). The average age of sexual debut was 17 years.
When the researchers examined subgroups, they found that one in four respondents who were African American, Hispanic, or low income reported delayed contraceptive initiation.
No association with unwanted pregnancy was found between effective versus less effective contraception methods. Timely contraceptive use increased during the study period from less than 10% in the 1970s to more than 25% in the 2000s, but condoms accounted for most of this increase. Use of other methods including long-acting reversible and short-acting hormonal options was low, especially among African American, Hispanic, and low-income women, Dr. Murray Horwitz and her colleagues noted.
The study was limited by several factors including the use of self-reports, lack of data on the exact start of contraceptive initiation, and the lack of association between contraceptive method and unwanted pregnancy, the researchers noted. However, the findings suggest that clinicians can help by intervening with young patients and educating them about early adoption of pregnancy prevention strategies.
The study was funded by the National Institutes of Health; Dr. Murray Horwitz was supported by an award from the NIH and Harvard Pilgrim Health Care Institute. Another researcher received support from Harvard Pilgrim Health Care Institute to provide mentorship for the study. The remaining researcher had no relevant financial disclosures.
SOURCE: Murray Horwitz M et al. Pediatrics. 2019;143(2):e20182463.
FROM PEDIATRICS
Key clinical point: Women who delayed using contraception were significantly more likely to become pregnant within 3 months of starting sexual activity than were those who had initiated contraception use, especially black, Hispanic, and low-income women.
Major finding: Unwanted pregnancy within 3 months of sexual debut was 3.7 times more likely in women who delayed initial contraception use, compared with those who had timely initiation.
Study details: The data come from a cross-sectional study including 26,359 women with sexual debuts between 1970 and 2014.
Disclosures: The study was funded by the National Institutes of Health; Dr. Murray Horwitz was supported by an award from the NIH and Harvard Pilgrim Health Care Institute. Another researcher received support from Harvard Pilgrim Health Care Institute to provide mentorship for the study. The remaining researcher had no relevant financial disclosures.
Source: Horwitz M et al. Pediatrics. 2019;143(2):e20182463.
Courts block Trump from eroding contraceptive mandate
Federal judges have blocked the Trump administration from weakening the Affordable Care Act’s contraceptive mandate in two separate orders that bar the President from letting more entities claim exemptions.
On Jan. 14, U.S. District Court Judge Wendy Beetlestone for the Eastern District of Pennsylvania issued a temporary nationwide ban on two rules that would have allowed an expanded group of employers and insurers to object to providing contraception coverage on either religious or moral grounds. The regulations, announced Nov. 7, 2018, were scheduled to take effect Jan. 14. The day before, U.S. District Judge Haywood Gilliam for the Northern District of California issued a similar temporary ban, but his order applied only to the 13 plaintiff states in the case, plus the District of Columbia.
While Pennsylvania and New Jersey are the only plaintiffs in the Judge Beetlestone case, she wrote that a nationwide injunction is required to protect numerous citizens from losing contraceptive coverage and resulting in “significant, direct, and proprietary harm” to states in the form of increased state-funded contraceptive services and increased costs associated with unintended pregnancies. Judge Gilliam provided similar reasoning in his Jan. 13 order, writing that the 13 plaintiff states have proven that rules promulgated by the U.S. Department of Health and Human Services would cause women to lose employer-sponsored contraceptive coverage, resulting in economic harm to the states.
California Attorney General Xavier Becerra, a plaintiff in the second case, said Judge Gilliam’s ruling will stop the Trump administration from denying millions of women and families access to co-pay birth control guaranteed by the Affordable Care Act.
“The law couldn’t be clearer – employers have no business interfering in women’s health care decisions,” Mr. Becerra said in the statement. “[The] court ruling stops another attempt by the Trump administration to trample on women’s access to basic reproductive care.”
At press time, the Trump administration officials had responded publicly to the court orders. The administration previously said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” HHS estimated that the rules would affect no more than 200 employers.
Mark Rienzi, president of the Becket Fund for Religious Liberty, a legal institute that defends religious freedoms, expressed disappointment at the court orders. Becket represents the Little Sisters of the Poor, an organization that has been fighting for several years for an exemption to the contraceptive mandate.
“Government bureaucrats should not be allowed to threaten the rights of the Little Sisters of the Poor to serve according to their Catholic beliefs,” Mr. Rienzi said in a statement. “Now the nuns are forced to keep fighting this unnecessary lawsuit to protect their ability to focus on caring for the poor. We are confident these decisions will be overturned.”
The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.
However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.
The Trump administration then announced new rules aimed at broadening exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. A second rule would protect nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions would apply to institutions of education, issuers, and individuals, but not to governmental entities.
Thirteen states and the District of Columbia then sued the Trump administration over the rules as well as Pennsylvania and New Jersey in a separate case.
The nationwide ban against the rules will remain in effect while the cases continue through the court system.
Federal judges have blocked the Trump administration from weakening the Affordable Care Act’s contraceptive mandate in two separate orders that bar the President from letting more entities claim exemptions.
On Jan. 14, U.S. District Court Judge Wendy Beetlestone for the Eastern District of Pennsylvania issued a temporary nationwide ban on two rules that would have allowed an expanded group of employers and insurers to object to providing contraception coverage on either religious or moral grounds. The regulations, announced Nov. 7, 2018, were scheduled to take effect Jan. 14. The day before, U.S. District Judge Haywood Gilliam for the Northern District of California issued a similar temporary ban, but his order applied only to the 13 plaintiff states in the case, plus the District of Columbia.
While Pennsylvania and New Jersey are the only plaintiffs in the Judge Beetlestone case, she wrote that a nationwide injunction is required to protect numerous citizens from losing contraceptive coverage and resulting in “significant, direct, and proprietary harm” to states in the form of increased state-funded contraceptive services and increased costs associated with unintended pregnancies. Judge Gilliam provided similar reasoning in his Jan. 13 order, writing that the 13 plaintiff states have proven that rules promulgated by the U.S. Department of Health and Human Services would cause women to lose employer-sponsored contraceptive coverage, resulting in economic harm to the states.
California Attorney General Xavier Becerra, a plaintiff in the second case, said Judge Gilliam’s ruling will stop the Trump administration from denying millions of women and families access to co-pay birth control guaranteed by the Affordable Care Act.
“The law couldn’t be clearer – employers have no business interfering in women’s health care decisions,” Mr. Becerra said in the statement. “[The] court ruling stops another attempt by the Trump administration to trample on women’s access to basic reproductive care.”
At press time, the Trump administration officials had responded publicly to the court orders. The administration previously said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” HHS estimated that the rules would affect no more than 200 employers.
Mark Rienzi, president of the Becket Fund for Religious Liberty, a legal institute that defends religious freedoms, expressed disappointment at the court orders. Becket represents the Little Sisters of the Poor, an organization that has been fighting for several years for an exemption to the contraceptive mandate.
“Government bureaucrats should not be allowed to threaten the rights of the Little Sisters of the Poor to serve according to their Catholic beliefs,” Mr. Rienzi said in a statement. “Now the nuns are forced to keep fighting this unnecessary lawsuit to protect their ability to focus on caring for the poor. We are confident these decisions will be overturned.”
The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.
However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.
The Trump administration then announced new rules aimed at broadening exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. A second rule would protect nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions would apply to institutions of education, issuers, and individuals, but not to governmental entities.
Thirteen states and the District of Columbia then sued the Trump administration over the rules as well as Pennsylvania and New Jersey in a separate case.
The nationwide ban against the rules will remain in effect while the cases continue through the court system.
Federal judges have blocked the Trump administration from weakening the Affordable Care Act’s contraceptive mandate in two separate orders that bar the President from letting more entities claim exemptions.
On Jan. 14, U.S. District Court Judge Wendy Beetlestone for the Eastern District of Pennsylvania issued a temporary nationwide ban on two rules that would have allowed an expanded group of employers and insurers to object to providing contraception coverage on either religious or moral grounds. The regulations, announced Nov. 7, 2018, were scheduled to take effect Jan. 14. The day before, U.S. District Judge Haywood Gilliam for the Northern District of California issued a similar temporary ban, but his order applied only to the 13 plaintiff states in the case, plus the District of Columbia.
While Pennsylvania and New Jersey are the only plaintiffs in the Judge Beetlestone case, she wrote that a nationwide injunction is required to protect numerous citizens from losing contraceptive coverage and resulting in “significant, direct, and proprietary harm” to states in the form of increased state-funded contraceptive services and increased costs associated with unintended pregnancies. Judge Gilliam provided similar reasoning in his Jan. 13 order, writing that the 13 plaintiff states have proven that rules promulgated by the U.S. Department of Health and Human Services would cause women to lose employer-sponsored contraceptive coverage, resulting in economic harm to the states.
California Attorney General Xavier Becerra, a plaintiff in the second case, said Judge Gilliam’s ruling will stop the Trump administration from denying millions of women and families access to co-pay birth control guaranteed by the Affordable Care Act.
“The law couldn’t be clearer – employers have no business interfering in women’s health care decisions,” Mr. Becerra said in the statement. “[The] court ruling stops another attempt by the Trump administration to trample on women’s access to basic reproductive care.”
At press time, the Trump administration officials had responded publicly to the court orders. The administration previously said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” HHS estimated that the rules would affect no more than 200 employers.
Mark Rienzi, president of the Becket Fund for Religious Liberty, a legal institute that defends religious freedoms, expressed disappointment at the court orders. Becket represents the Little Sisters of the Poor, an organization that has been fighting for several years for an exemption to the contraceptive mandate.
“Government bureaucrats should not be allowed to threaten the rights of the Little Sisters of the Poor to serve according to their Catholic beliefs,” Mr. Rienzi said in a statement. “Now the nuns are forced to keep fighting this unnecessary lawsuit to protect their ability to focus on caring for the poor. We are confident these decisions will be overturned.”
The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.
However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.
The Trump administration then announced new rules aimed at broadening exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. A second rule would protect nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions would apply to institutions of education, issuers, and individuals, but not to governmental entities.
Thirteen states and the District of Columbia then sued the Trump administration over the rules as well as Pennsylvania and New Jersey in a separate case.
The nationwide ban against the rules will remain in effect while the cases continue through the court system.
FDA expands Essure’s postmarketing surveillance study
The study, ordered in 2016, will now run 5 years instead of 3, and the cohort will be enlarged to add any women who elect implantation while the device is still on the market, FDA Commissioner Scott Gottlieb, MD, announced in a press statement. The agency also added a key biological measure: All patients with Essure will undergo regular blood work to evaluate proinflammatory markers that could be device related.
“We’re requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation,” Dr. Gottlieb said. “This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure.”
The device has been associated with severe problems in some patients, he noted.
“I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health.”
The study expansion comes as Bayer is facing more than 16,000 lawsuits over adverse events associated with Essure implantation.
Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide. Bayer claims the device is 99% effective in preventing pregnancy, but it’s also been associated with some serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. In view of these – and more than 15,000 adverse events reported to the FDA – the agency announced new restrictions on Essure earlier this year. Those restrictions, plus a prior boxed warning on the label, contributed to about a 70% decline in U.S. sales, which Bayer says prompted the discontinuation.
The open-label prospective observational study will compare women who have the Essure device to a matched cohort that underwent laparoscopic tubal ligation. The main safety endpoints are chronic pelvic pain and abnormal uterine bleeding, as well as the new measure of inflammatory markers. As of Dec. 3, 791 patients have been enrolled (293 in the Essure arm and 498 in the laparoscopic tubal ligation arm).
Women who have the implant now and remain free of any adverse events should probably keep the device, Dr. Gottlieb advised.
“We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them.”
The study, ordered in 2016, will now run 5 years instead of 3, and the cohort will be enlarged to add any women who elect implantation while the device is still on the market, FDA Commissioner Scott Gottlieb, MD, announced in a press statement. The agency also added a key biological measure: All patients with Essure will undergo regular blood work to evaluate proinflammatory markers that could be device related.
“We’re requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation,” Dr. Gottlieb said. “This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure.”
The device has been associated with severe problems in some patients, he noted.
“I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health.”
The study expansion comes as Bayer is facing more than 16,000 lawsuits over adverse events associated with Essure implantation.
Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide. Bayer claims the device is 99% effective in preventing pregnancy, but it’s also been associated with some serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. In view of these – and more than 15,000 adverse events reported to the FDA – the agency announced new restrictions on Essure earlier this year. Those restrictions, plus a prior boxed warning on the label, contributed to about a 70% decline in U.S. sales, which Bayer says prompted the discontinuation.
The open-label prospective observational study will compare women who have the Essure device to a matched cohort that underwent laparoscopic tubal ligation. The main safety endpoints are chronic pelvic pain and abnormal uterine bleeding, as well as the new measure of inflammatory markers. As of Dec. 3, 791 patients have been enrolled (293 in the Essure arm and 498 in the laparoscopic tubal ligation arm).
Women who have the implant now and remain free of any adverse events should probably keep the device, Dr. Gottlieb advised.
“We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them.”
The study, ordered in 2016, will now run 5 years instead of 3, and the cohort will be enlarged to add any women who elect implantation while the device is still on the market, FDA Commissioner Scott Gottlieb, MD, announced in a press statement. The agency also added a key biological measure: All patients with Essure will undergo regular blood work to evaluate proinflammatory markers that could be device related.
“We’re requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation,” Dr. Gottlieb said. “This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure.”
The device has been associated with severe problems in some patients, he noted.
“I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health.”
The study expansion comes as Bayer is facing more than 16,000 lawsuits over adverse events associated with Essure implantation.
Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide. Bayer claims the device is 99% effective in preventing pregnancy, but it’s also been associated with some serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. In view of these – and more than 15,000 adverse events reported to the FDA – the agency announced new restrictions on Essure earlier this year. Those restrictions, plus a prior boxed warning on the label, contributed to about a 70% decline in U.S. sales, which Bayer says prompted the discontinuation.
The open-label prospective observational study will compare women who have the Essure device to a matched cohort that underwent laparoscopic tubal ligation. The main safety endpoints are chronic pelvic pain and abnormal uterine bleeding, as well as the new measure of inflammatory markers. As of Dec. 3, 791 patients have been enrolled (293 in the Essure arm and 498 in the laparoscopic tubal ligation arm).
Women who have the implant now and remain free of any adverse events should probably keep the device, Dr. Gottlieb advised.
“We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them.”
Is an IUD a good contraceptive choice for a never sexually active teen?
Expert Commentary
Data demonstrate efficacy and safety of the IUD in adolescents. In addition, IUDs (particularly the levonorgestrel-containing IUD) have many noncontraceptive benefits. There is still reluctance, however, among clinicians to use IUDs in adolescents. In a sample of fellows of the American College of Obstetricians and Gynecologists, only 43% considered adolescents appropriate candidates for use of an IUD.1
Study details
In this retrospective chart review, Kebodeaux and Schwartz sought to compare successful IUD insertion rates on first attempt in 120 sexually active (SA) and 82 never sexually active (NSA) adolescents. The IUD type used for all women was the 52-mg levonorgestrel IUD (Mirena), except for 3 copper IUDs (Paragard) used in the SA group. The primary indications for IUD use were contraception (85.2%) in the SA group and abnormal uterine bleeding (43.9%) and menstrual suppression (24.4%) in the NSA group.
In the NSA group, 82.9% of adolescents had had some type of prior treatment affecting the menstrual cycle, compared with 60.9% in the SA group (P = .001).
Non–office insertion. Either a sedation unit or operating room was utilized in 5.5% of the IUD insertions in the SA group and 47.6% of the NSA group. Among the 39 adolescents in the NSA group undergoing non–office insertion, 19 (48.7%) had special needs (learning or intellectual disabilities, autism/autism spectrum, or physical disabilities, such as cerebral palsy). Only 1 adolescent with special needs in the NSA group had an office insertion compared with 5 out of 6 in the SA group.
The performance of another procedure other than the IUD insertion (including diagnostic laparoscopy and hymenectomy) was common among adolescents undergoing procedures in the sedation unit or operating room who did not have special needs. It is also important to note that adolescents with special needs were routinely offered insertion under anesthesia while SA adolescents were offered insertion under anesthesia only if they were undergoing another procedure as well.
Study strengths and weaknesses
The study’s strengths include IUD insertions performed at a children’s hospital by providers with experience working with adolescent populations. This likely accounts for the high rates of “tolerance of the procedure well” (93.8% in the SA group vs 81.7% in the NSA group; P = .006). The study also included a patient population—adolescents with special needs—that has not been studied relative to IUD use previously.
A significant weakness of the study, however, is that there are no long-term follow-up data, particularly related to continuation rates.
These study findings provides further support to combat the myth that adolescents, particularly if nulliparous or not sexually active, are not suitable candidates for IUD use. However, if they have never been sexually active or have special needs, IUD insertion under sedation or in an operating room may be necessary. It is also likely that selection of the IUD as an option by an adolescent and overall tolerance of the insertion procedure requires providers with experience in caring for adolescents as well as providers possessing good counseling skills.
—Ronald T. Burkman, MD
1. Luchowski AT, Anderson BL, Power ML, Reglan GB, Espey E, Shulkin J. Obstetrician-gynecologists and contraception: practice and opinions about the use of IUDs in nulliparous women, adolescents and other patient populations. Contraception. 2014;89:572-577.
Expert Commentary
Data demonstrate efficacy and safety of the IUD in adolescents. In addition, IUDs (particularly the levonorgestrel-containing IUD) have many noncontraceptive benefits. There is still reluctance, however, among clinicians to use IUDs in adolescents. In a sample of fellows of the American College of Obstetricians and Gynecologists, only 43% considered adolescents appropriate candidates for use of an IUD.1
Study details
In this retrospective chart review, Kebodeaux and Schwartz sought to compare successful IUD insertion rates on first attempt in 120 sexually active (SA) and 82 never sexually active (NSA) adolescents. The IUD type used for all women was the 52-mg levonorgestrel IUD (Mirena), except for 3 copper IUDs (Paragard) used in the SA group. The primary indications for IUD use were contraception (85.2%) in the SA group and abnormal uterine bleeding (43.9%) and menstrual suppression (24.4%) in the NSA group.
In the NSA group, 82.9% of adolescents had had some type of prior treatment affecting the menstrual cycle, compared with 60.9% in the SA group (P = .001).
Non–office insertion. Either a sedation unit or operating room was utilized in 5.5% of the IUD insertions in the SA group and 47.6% of the NSA group. Among the 39 adolescents in the NSA group undergoing non–office insertion, 19 (48.7%) had special needs (learning or intellectual disabilities, autism/autism spectrum, or physical disabilities, such as cerebral palsy). Only 1 adolescent with special needs in the NSA group had an office insertion compared with 5 out of 6 in the SA group.
The performance of another procedure other than the IUD insertion (including diagnostic laparoscopy and hymenectomy) was common among adolescents undergoing procedures in the sedation unit or operating room who did not have special needs. It is also important to note that adolescents with special needs were routinely offered insertion under anesthesia while SA adolescents were offered insertion under anesthesia only if they were undergoing another procedure as well.
Study strengths and weaknesses
The study’s strengths include IUD insertions performed at a children’s hospital by providers with experience working with adolescent populations. This likely accounts for the high rates of “tolerance of the procedure well” (93.8% in the SA group vs 81.7% in the NSA group; P = .006). The study also included a patient population—adolescents with special needs—that has not been studied relative to IUD use previously.
A significant weakness of the study, however, is that there are no long-term follow-up data, particularly related to continuation rates.
These study findings provides further support to combat the myth that adolescents, particularly if nulliparous or not sexually active, are not suitable candidates for IUD use. However, if they have never been sexually active or have special needs, IUD insertion under sedation or in an operating room may be necessary. It is also likely that selection of the IUD as an option by an adolescent and overall tolerance of the insertion procedure requires providers with experience in caring for adolescents as well as providers possessing good counseling skills.
—Ronald T. Burkman, MD
Expert Commentary
Data demonstrate efficacy and safety of the IUD in adolescents. In addition, IUDs (particularly the levonorgestrel-containing IUD) have many noncontraceptive benefits. There is still reluctance, however, among clinicians to use IUDs in adolescents. In a sample of fellows of the American College of Obstetricians and Gynecologists, only 43% considered adolescents appropriate candidates for use of an IUD.1
Study details
In this retrospective chart review, Kebodeaux and Schwartz sought to compare successful IUD insertion rates on first attempt in 120 sexually active (SA) and 82 never sexually active (NSA) adolescents. The IUD type used for all women was the 52-mg levonorgestrel IUD (Mirena), except for 3 copper IUDs (Paragard) used in the SA group. The primary indications for IUD use were contraception (85.2%) in the SA group and abnormal uterine bleeding (43.9%) and menstrual suppression (24.4%) in the NSA group.
In the NSA group, 82.9% of adolescents had had some type of prior treatment affecting the menstrual cycle, compared with 60.9% in the SA group (P = .001).
Non–office insertion. Either a sedation unit or operating room was utilized in 5.5% of the IUD insertions in the SA group and 47.6% of the NSA group. Among the 39 adolescents in the NSA group undergoing non–office insertion, 19 (48.7%) had special needs (learning or intellectual disabilities, autism/autism spectrum, or physical disabilities, such as cerebral palsy). Only 1 adolescent with special needs in the NSA group had an office insertion compared with 5 out of 6 in the SA group.
The performance of another procedure other than the IUD insertion (including diagnostic laparoscopy and hymenectomy) was common among adolescents undergoing procedures in the sedation unit or operating room who did not have special needs. It is also important to note that adolescents with special needs were routinely offered insertion under anesthesia while SA adolescents were offered insertion under anesthesia only if they were undergoing another procedure as well.
Study strengths and weaknesses
The study’s strengths include IUD insertions performed at a children’s hospital by providers with experience working with adolescent populations. This likely accounts for the high rates of “tolerance of the procedure well” (93.8% in the SA group vs 81.7% in the NSA group; P = .006). The study also included a patient population—adolescents with special needs—that has not been studied relative to IUD use previously.
A significant weakness of the study, however, is that there are no long-term follow-up data, particularly related to continuation rates.
These study findings provides further support to combat the myth that adolescents, particularly if nulliparous or not sexually active, are not suitable candidates for IUD use. However, if they have never been sexually active or have special needs, IUD insertion under sedation or in an operating room may be necessary. It is also likely that selection of the IUD as an option by an adolescent and overall tolerance of the insertion procedure requires providers with experience in caring for adolescents as well as providers possessing good counseling skills.
—Ronald T. Burkman, MD
1. Luchowski AT, Anderson BL, Power ML, Reglan GB, Espey E, Shulkin J. Obstetrician-gynecologists and contraception: practice and opinions about the use of IUDs in nulliparous women, adolescents and other patient populations. Contraception. 2014;89:572-577.
1. Luchowski AT, Anderson BL, Power ML, Reglan GB, Espey E, Shulkin J. Obstetrician-gynecologists and contraception: practice and opinions about the use of IUDs in nulliparous women, adolescents and other patient populations. Contraception. 2014;89:572-577.
Abortion measures continue to fall
Three important national measures of abortion dropped by at least 19% from 2006 to 2015, according to the Centers for Disease Control and Prevention.
Surgical and medical abortions reported to the CDC dropped by 24%, going from almost 843,000 in 2006 to 638,000 in 2015, with declines occurring every year, Tara C. Jatlaoui, MD, and her associates at the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, reported in Morbidity and Mortality Weekly Report Surveillance Summaries.
Over that same time period, the abortion rate fell from 15.9 per 1,000 women aged 15-44 years to 11.8 per 1,000 – a decline of 26%. Abortion ratio – the number of abortions per 1,000 live births within a given population – declined by 19%, dropping from 233 abortions per 1,000 live births in 2006 to 188 abortions per 1,000 live births in 2015, the investigators reported. The findings were based on data from 49 areas that continuously reported over the study period (excludes California, Maryland, and New Hampshire but includes the District of Columbia and New York City).
Abortion rates were highest for women aged 20-29 years for the study period, and this age group accounted for the largest share among the 44 reporting areas that provided data by maternal age each year. Those under age 15 years had the largest drops by age in total number of abortions (40%) and abortion rate (58%) but had the highest, by far, abortion ratio for each year of the study (700 per 1,000 live births in that age group in 2015. The abortion ratio for 15- to 19-year-olds was 289 per 1,000 live births).
The percentage of abortions performed before 14 weeks’ gestation changed little, going from 91.5% in 2006 to 91% in 2015, but “a shift occurred toward earlier gestational ages,” they noted. The percentage of abortions performed before or at 8 weeks increased 3% and those done at 9-13 weeks dropped almost 9% among the 33 areas that reported gestational age every year. Abortions done after 13 weeks gestation represented 9% of all abortions during the study period, with an increase of 7% occurring from 2006 to 2015, Dr. Jatlaoui and her associates said.
Removing barriers such as cost, “insufficient provider reimbursement and training, inadequate client-centered counseling, lack of youth-friendly services, and low client awareness ... might help improve contraceptive use, potentially reducing the number of unintended pregnancies and the number of abortions performed in the United States,” the researchers wrote.
SOURCE: Jatlaoui TC et al. MMWR Surveill Summ. 2018 Nov 23(13):1-45.
Three important national measures of abortion dropped by at least 19% from 2006 to 2015, according to the Centers for Disease Control and Prevention.
Surgical and medical abortions reported to the CDC dropped by 24%, going from almost 843,000 in 2006 to 638,000 in 2015, with declines occurring every year, Tara C. Jatlaoui, MD, and her associates at the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, reported in Morbidity and Mortality Weekly Report Surveillance Summaries.
Over that same time period, the abortion rate fell from 15.9 per 1,000 women aged 15-44 years to 11.8 per 1,000 – a decline of 26%. Abortion ratio – the number of abortions per 1,000 live births within a given population – declined by 19%, dropping from 233 abortions per 1,000 live births in 2006 to 188 abortions per 1,000 live births in 2015, the investigators reported. The findings were based on data from 49 areas that continuously reported over the study period (excludes California, Maryland, and New Hampshire but includes the District of Columbia and New York City).
Abortion rates were highest for women aged 20-29 years for the study period, and this age group accounted for the largest share among the 44 reporting areas that provided data by maternal age each year. Those under age 15 years had the largest drops by age in total number of abortions (40%) and abortion rate (58%) but had the highest, by far, abortion ratio for each year of the study (700 per 1,000 live births in that age group in 2015. The abortion ratio for 15- to 19-year-olds was 289 per 1,000 live births).
The percentage of abortions performed before 14 weeks’ gestation changed little, going from 91.5% in 2006 to 91% in 2015, but “a shift occurred toward earlier gestational ages,” they noted. The percentage of abortions performed before or at 8 weeks increased 3% and those done at 9-13 weeks dropped almost 9% among the 33 areas that reported gestational age every year. Abortions done after 13 weeks gestation represented 9% of all abortions during the study period, with an increase of 7% occurring from 2006 to 2015, Dr. Jatlaoui and her associates said.
Removing barriers such as cost, “insufficient provider reimbursement and training, inadequate client-centered counseling, lack of youth-friendly services, and low client awareness ... might help improve contraceptive use, potentially reducing the number of unintended pregnancies and the number of abortions performed in the United States,” the researchers wrote.
SOURCE: Jatlaoui TC et al. MMWR Surveill Summ. 2018 Nov 23(13):1-45.
Three important national measures of abortion dropped by at least 19% from 2006 to 2015, according to the Centers for Disease Control and Prevention.
Surgical and medical abortions reported to the CDC dropped by 24%, going from almost 843,000 in 2006 to 638,000 in 2015, with declines occurring every year, Tara C. Jatlaoui, MD, and her associates at the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, reported in Morbidity and Mortality Weekly Report Surveillance Summaries.
Over that same time period, the abortion rate fell from 15.9 per 1,000 women aged 15-44 years to 11.8 per 1,000 – a decline of 26%. Abortion ratio – the number of abortions per 1,000 live births within a given population – declined by 19%, dropping from 233 abortions per 1,000 live births in 2006 to 188 abortions per 1,000 live births in 2015, the investigators reported. The findings were based on data from 49 areas that continuously reported over the study period (excludes California, Maryland, and New Hampshire but includes the District of Columbia and New York City).
Abortion rates were highest for women aged 20-29 years for the study period, and this age group accounted for the largest share among the 44 reporting areas that provided data by maternal age each year. Those under age 15 years had the largest drops by age in total number of abortions (40%) and abortion rate (58%) but had the highest, by far, abortion ratio for each year of the study (700 per 1,000 live births in that age group in 2015. The abortion ratio for 15- to 19-year-olds was 289 per 1,000 live births).
The percentage of abortions performed before 14 weeks’ gestation changed little, going from 91.5% in 2006 to 91% in 2015, but “a shift occurred toward earlier gestational ages,” they noted. The percentage of abortions performed before or at 8 weeks increased 3% and those done at 9-13 weeks dropped almost 9% among the 33 areas that reported gestational age every year. Abortions done after 13 weeks gestation represented 9% of all abortions during the study period, with an increase of 7% occurring from 2006 to 2015, Dr. Jatlaoui and her associates said.
Removing barriers such as cost, “insufficient provider reimbursement and training, inadequate client-centered counseling, lack of youth-friendly services, and low client awareness ... might help improve contraceptive use, potentially reducing the number of unintended pregnancies and the number of abortions performed in the United States,” the researchers wrote.
SOURCE: Jatlaoui TC et al. MMWR Surveill Summ. 2018 Nov 23(13):1-45.
FROM MMWR SURVEILLANCE SUMMARIES
Levonorgestrel implant right after delivery does not affect breastfeeding, infant growth
Researchers found no significant differences in infant growth, changes in breastfeeding initiation or breastfeeding continuation at 3-month and 6-month follow-up among women who received a levonorgestrel contraception implant very soon after delivery, compared with women who waited to receive the implant.
“These findings are consistent with the preponderance of literature supporting the hypothesis that progestin-containing contraceptives do not compromise a woman’s ability to initiate or sustain breastfeeding and do not adversely affect infant growth,” Sarah Averbach, MD, of the University of California, San Francisco, and her colleagues wrote in their study published in Contraception.
Dr. Averbach and her colleagues randomized 96 women to receive a two-rod levonorgestrel (LNG)–releasing subdermal contraceptive implant within 5 days of delivery (mean time, 36 hours post delivery) and 87 women to delay the implant to between 6 and 8 weeks at a postpartum follow-up visit (mean time, 68 days). The women were a minimum of 18 years old with a recent vaginal or cesarean section delivery at a Ugandan hospital; 55% of the women had at least three children, and 73% said they had prior experience breastfeeding. The researchers then examined infant weight change and infant head circumference change at 6 months from birth, time to lactogenesis, and whether mothers continued to breastfeed at 3 months and 6 months after birth.
Infant weight was similar in the immediate-implant group (4,632 g), compared with the delayed-implant group (4,407 g; P = .26); infant head circumference was similar between both groups (9.3 cm vs. 9.5 cm; P = .70) at 6 months as well. The time to lactogenesis was not significantly different in the immediate-implant (65 hours) and delayed-implant (63 hours; P = .84) groups. At 3 months, 74% of immediate-implant participants and 71% of delayed-implant participants said they were breastfeeding exclusively (P = .74); at 6 months, 48% of immediate implant participants and 52% of delayed implant participants reported exclusive breastfeeding (P equals .58).
Limitations of the study included follow-up to only 6 months and selection of participants with previous breastfeeding experience. Researchers also noted better measurements of infant and maternal breast milk intake also could be used and limit generalization of the results.
This study was funded by the Society of Family Planning Research Fund. Dr. Averbach is supported by an award from the Eunice Kennedy Shriver National Institute of Child Health & Human Development. The other authors had no relevant financial disclosures.
SOURCE: Averbach S et al. Contraception. 2018. doi: 10.1016/j.contraception.2018.10.008.
Researchers found no significant differences in infant growth, changes in breastfeeding initiation or breastfeeding continuation at 3-month and 6-month follow-up among women who received a levonorgestrel contraception implant very soon after delivery, compared with women who waited to receive the implant.
“These findings are consistent with the preponderance of literature supporting the hypothesis that progestin-containing contraceptives do not compromise a woman’s ability to initiate or sustain breastfeeding and do not adversely affect infant growth,” Sarah Averbach, MD, of the University of California, San Francisco, and her colleagues wrote in their study published in Contraception.
Dr. Averbach and her colleagues randomized 96 women to receive a two-rod levonorgestrel (LNG)–releasing subdermal contraceptive implant within 5 days of delivery (mean time, 36 hours post delivery) and 87 women to delay the implant to between 6 and 8 weeks at a postpartum follow-up visit (mean time, 68 days). The women were a minimum of 18 years old with a recent vaginal or cesarean section delivery at a Ugandan hospital; 55% of the women had at least three children, and 73% said they had prior experience breastfeeding. The researchers then examined infant weight change and infant head circumference change at 6 months from birth, time to lactogenesis, and whether mothers continued to breastfeed at 3 months and 6 months after birth.
Infant weight was similar in the immediate-implant group (4,632 g), compared with the delayed-implant group (4,407 g; P = .26); infant head circumference was similar between both groups (9.3 cm vs. 9.5 cm; P = .70) at 6 months as well. The time to lactogenesis was not significantly different in the immediate-implant (65 hours) and delayed-implant (63 hours; P = .84) groups. At 3 months, 74% of immediate-implant participants and 71% of delayed-implant participants said they were breastfeeding exclusively (P = .74); at 6 months, 48% of immediate implant participants and 52% of delayed implant participants reported exclusive breastfeeding (P equals .58).
Limitations of the study included follow-up to only 6 months and selection of participants with previous breastfeeding experience. Researchers also noted better measurements of infant and maternal breast milk intake also could be used and limit generalization of the results.
This study was funded by the Society of Family Planning Research Fund. Dr. Averbach is supported by an award from the Eunice Kennedy Shriver National Institute of Child Health & Human Development. The other authors had no relevant financial disclosures.
SOURCE: Averbach S et al. Contraception. 2018. doi: 10.1016/j.contraception.2018.10.008.
Researchers found no significant differences in infant growth, changes in breastfeeding initiation or breastfeeding continuation at 3-month and 6-month follow-up among women who received a levonorgestrel contraception implant very soon after delivery, compared with women who waited to receive the implant.
“These findings are consistent with the preponderance of literature supporting the hypothesis that progestin-containing contraceptives do not compromise a woman’s ability to initiate or sustain breastfeeding and do not adversely affect infant growth,” Sarah Averbach, MD, of the University of California, San Francisco, and her colleagues wrote in their study published in Contraception.
Dr. Averbach and her colleagues randomized 96 women to receive a two-rod levonorgestrel (LNG)–releasing subdermal contraceptive implant within 5 days of delivery (mean time, 36 hours post delivery) and 87 women to delay the implant to between 6 and 8 weeks at a postpartum follow-up visit (mean time, 68 days). The women were a minimum of 18 years old with a recent vaginal or cesarean section delivery at a Ugandan hospital; 55% of the women had at least three children, and 73% said they had prior experience breastfeeding. The researchers then examined infant weight change and infant head circumference change at 6 months from birth, time to lactogenesis, and whether mothers continued to breastfeed at 3 months and 6 months after birth.
Infant weight was similar in the immediate-implant group (4,632 g), compared with the delayed-implant group (4,407 g; P = .26); infant head circumference was similar between both groups (9.3 cm vs. 9.5 cm; P = .70) at 6 months as well. The time to lactogenesis was not significantly different in the immediate-implant (65 hours) and delayed-implant (63 hours; P = .84) groups. At 3 months, 74% of immediate-implant participants and 71% of delayed-implant participants said they were breastfeeding exclusively (P = .74); at 6 months, 48% of immediate implant participants and 52% of delayed implant participants reported exclusive breastfeeding (P equals .58).
Limitations of the study included follow-up to only 6 months and selection of participants with previous breastfeeding experience. Researchers also noted better measurements of infant and maternal breast milk intake also could be used and limit generalization of the results.
This study was funded by the Society of Family Planning Research Fund. Dr. Averbach is supported by an award from the Eunice Kennedy Shriver National Institute of Child Health & Human Development. The other authors had no relevant financial disclosures.
SOURCE: Averbach S et al. Contraception. 2018. doi: 10.1016/j.contraception.2018.10.008.
FROM CONTRACEPTION
Key clinical point:
Major finding: Infant weight was similar in the immediate-implant group (4,632 g), compared with the delayed-implant group (4,407 g; P = .26); infant head circumference was similar between both groups (9.3 cm vs. 9.5 cm; P = .70) at 6 months as well.
Study details: A randomized trial of 96 women in Uganda who received a contraceptive implant less than 5 days after delivery and 86 women who received the implant between 6 and 8 weeks post partum.
Disclosures: This study was funded by the Society of Family Planning Research Fund. Dr. Averbach is supported by an award from the Eunice Kennedy Shriver National Institute of Child Health & Human Development. The other authors had no relevant financial disclosures.
Source: Averbach S et al. Contraception. 2018. doi: 10.1016/j.contraception.2018.10.008.
Is salpingectomy (vs standard tubal ligation) for sterilization a feasible option at cesarean delivery?
Concerns over discretion, efficacy lead teen females to use emergency contraception
Emergency contraception is perceived as “easy, effective, and discrete,” especially when compared with nonemergent contraception and condoms, according to a qualitative study of contraceptive behaviors and decision making among adolescent females who had previously used emergency contraception (EC) or planned to use it.
“Three main themes emerged from our interviews: There are multiple perceived benefits to using EC, nonemergent contraception (NEC) use is challenging, and the decision to use NEC is multifactorial,” lead author Geetha N. Fink, MD, MPH, and her coauthors wrote in the Journal of Pediatric and Adolescent Gynecology.
The investigators reviewed interview transcripts and questionnaire responses from 28 adolescent females who had all used or were planning to use EC. The participants, who were recruited from school-based health centers (SBHC) in New York, reported having used EC a mean of 3.5 times (range 0-30 times), noted Dr. Fink of the department of obstetrics, gynecology and reproductive sciences at the Icahn School of Medicine at Mount Sinai in New York and her colleagues.
SBHCs in New York can distribute EC for free and – once general consent to care at the SBHC is provided at the start of each school year– without parental notification. This ease of access contributed to EC use, along with its minimal side effects. EC also can “be used discretely without the involvement of the partner,” Dr. Fink and her coauthors noted. Although the majority of participants stated being comfortable discussing their EC use, “they still appreciated that EC does not require partner involvement or awareness, unlike condoms or withdrawal.”
The participants’ decision making often was influenced by misperception; 65% incorrectly stated that EC was 90%-99% effective, and NEC use was ascribed to beliefs that “excess EC decreases efficacy or is detrimental to health and social interactions.” At the same time, Dr. Fink and her colleagues found that NEC use was associated with participants who had more sexual experience or who correctly identified it as more effective than EC.
“Our findings suggest that as adolescents gained more experience with sex and counseling, and also matured, they appeared to be more likely to utilize NEC,” they wrote.
Dr. Fink and her associates shared limitations of their study, including the uniqueness of SBHCs in New York City in providing comprehensive health care options, compared with those in the rest of the United States. However, they also noted the value in interviewing adolescent EC users and therefore better understanding why they’ve made these contraceptive decisions.
“We suspect many more students would benefit from access to EC and the SBHC, but may be unaware of these resources. We recommend increased efforts to promote awareness of these resources in schools, especially incorporated into sexual education. EC should be readily available for all adolescents,” they wrote.
The study was funded through a grant from the Society of Family Planning. No conflicts of interest were reported.
SOURCE: Fink GN et al. J Pediatr Adolesc Gynecol. 2018. doi: 10.1016/j.jpag.2018.10.005.
This study was very well conducted and provides genuine insight into adolescents who access contraception and their views about the difference between emergency contraception and nonemergent contraception. It also highlights that we have so much more work to do, from a public health perspective, when it comes to educating youth about the efficacy of contraception. If young people who have easier access to emergency contraception still believe incorrect information, what about those people who have minimal access?
Catherine Cansino, MD, MPH , is an associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the article by Fink et al.
This study was very well conducted and provides genuine insight into adolescents who access contraception and their views about the difference between emergency contraception and nonemergent contraception. It also highlights that we have so much more work to do, from a public health perspective, when it comes to educating youth about the efficacy of contraception. If young people who have easier access to emergency contraception still believe incorrect information, what about those people who have minimal access?
Catherine Cansino, MD, MPH , is an associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the article by Fink et al.
This study was very well conducted and provides genuine insight into adolescents who access contraception and their views about the difference between emergency contraception and nonemergent contraception. It also highlights that we have so much more work to do, from a public health perspective, when it comes to educating youth about the efficacy of contraception. If young people who have easier access to emergency contraception still believe incorrect information, what about those people who have minimal access?
Catherine Cansino, MD, MPH , is an associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the article by Fink et al.
Emergency contraception is perceived as “easy, effective, and discrete,” especially when compared with nonemergent contraception and condoms, according to a qualitative study of contraceptive behaviors and decision making among adolescent females who had previously used emergency contraception (EC) or planned to use it.
“Three main themes emerged from our interviews: There are multiple perceived benefits to using EC, nonemergent contraception (NEC) use is challenging, and the decision to use NEC is multifactorial,” lead author Geetha N. Fink, MD, MPH, and her coauthors wrote in the Journal of Pediatric and Adolescent Gynecology.
The investigators reviewed interview transcripts and questionnaire responses from 28 adolescent females who had all used or were planning to use EC. The participants, who were recruited from school-based health centers (SBHC) in New York, reported having used EC a mean of 3.5 times (range 0-30 times), noted Dr. Fink of the department of obstetrics, gynecology and reproductive sciences at the Icahn School of Medicine at Mount Sinai in New York and her colleagues.
SBHCs in New York can distribute EC for free and – once general consent to care at the SBHC is provided at the start of each school year– without parental notification. This ease of access contributed to EC use, along with its minimal side effects. EC also can “be used discretely without the involvement of the partner,” Dr. Fink and her coauthors noted. Although the majority of participants stated being comfortable discussing their EC use, “they still appreciated that EC does not require partner involvement or awareness, unlike condoms or withdrawal.”
The participants’ decision making often was influenced by misperception; 65% incorrectly stated that EC was 90%-99% effective, and NEC use was ascribed to beliefs that “excess EC decreases efficacy or is detrimental to health and social interactions.” At the same time, Dr. Fink and her colleagues found that NEC use was associated with participants who had more sexual experience or who correctly identified it as more effective than EC.
“Our findings suggest that as adolescents gained more experience with sex and counseling, and also matured, they appeared to be more likely to utilize NEC,” they wrote.
Dr. Fink and her associates shared limitations of their study, including the uniqueness of SBHCs in New York City in providing comprehensive health care options, compared with those in the rest of the United States. However, they also noted the value in interviewing adolescent EC users and therefore better understanding why they’ve made these contraceptive decisions.
“We suspect many more students would benefit from access to EC and the SBHC, but may be unaware of these resources. We recommend increased efforts to promote awareness of these resources in schools, especially incorporated into sexual education. EC should be readily available for all adolescents,” they wrote.
The study was funded through a grant from the Society of Family Planning. No conflicts of interest were reported.
SOURCE: Fink GN et al. J Pediatr Adolesc Gynecol. 2018. doi: 10.1016/j.jpag.2018.10.005.
Emergency contraception is perceived as “easy, effective, and discrete,” especially when compared with nonemergent contraception and condoms, according to a qualitative study of contraceptive behaviors and decision making among adolescent females who had previously used emergency contraception (EC) or planned to use it.
“Three main themes emerged from our interviews: There are multiple perceived benefits to using EC, nonemergent contraception (NEC) use is challenging, and the decision to use NEC is multifactorial,” lead author Geetha N. Fink, MD, MPH, and her coauthors wrote in the Journal of Pediatric and Adolescent Gynecology.
The investigators reviewed interview transcripts and questionnaire responses from 28 adolescent females who had all used or were planning to use EC. The participants, who were recruited from school-based health centers (SBHC) in New York, reported having used EC a mean of 3.5 times (range 0-30 times), noted Dr. Fink of the department of obstetrics, gynecology and reproductive sciences at the Icahn School of Medicine at Mount Sinai in New York and her colleagues.
SBHCs in New York can distribute EC for free and – once general consent to care at the SBHC is provided at the start of each school year– without parental notification. This ease of access contributed to EC use, along with its minimal side effects. EC also can “be used discretely without the involvement of the partner,” Dr. Fink and her coauthors noted. Although the majority of participants stated being comfortable discussing their EC use, “they still appreciated that EC does not require partner involvement or awareness, unlike condoms or withdrawal.”
The participants’ decision making often was influenced by misperception; 65% incorrectly stated that EC was 90%-99% effective, and NEC use was ascribed to beliefs that “excess EC decreases efficacy or is detrimental to health and social interactions.” At the same time, Dr. Fink and her colleagues found that NEC use was associated with participants who had more sexual experience or who correctly identified it as more effective than EC.
“Our findings suggest that as adolescents gained more experience with sex and counseling, and also matured, they appeared to be more likely to utilize NEC,” they wrote.
Dr. Fink and her associates shared limitations of their study, including the uniqueness of SBHCs in New York City in providing comprehensive health care options, compared with those in the rest of the United States. However, they also noted the value in interviewing adolescent EC users and therefore better understanding why they’ve made these contraceptive decisions.
“We suspect many more students would benefit from access to EC and the SBHC, but may be unaware of these resources. We recommend increased efforts to promote awareness of these resources in schools, especially incorporated into sexual education. EC should be readily available for all adolescents,” they wrote.
The study was funded through a grant from the Society of Family Planning. No conflicts of interest were reported.
SOURCE: Fink GN et al. J Pediatr Adolesc Gynecol. 2018. doi: 10.1016/j.jpag.2018.10.005.
FROM THE JOURNAL OF PEDIATRIC AND ADOLESCENT GYNECOLOGY
Key clinical point: 65% of adolescent females who were interviewed incorrectly believed that emergency contraception is 90%-99% effective.
Major finding: Adolescents who use emergency contraception prefer it over nonemergent contraception because it is perceived as easy to use and a more private alternative.
Study details: A study of 28 interviews of adolescent females who self-reported emergency contraception use.
Disclosures: The study was funded through a grant from the Society of Family Planning. No conflicts of interest were reported.
Source: Fink GN et al. J Pediatr Adolesc Gynecol. 2018. doi: 10.1016/j.jpag.2018.10.005.
Trump administration rule erodes ACA contraceptive mandate
More employers can opt out of providing contraception coverage to their employees under final regulations from the Trump administration that narrow the Affordable Care Act’s contraceptive mandate.
The two regulations, released Nov. 7, allow an expanded group of employers and insurers to get out of covering contraception methods by objecting on either religious or moral grounds.
The first rule broadens exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second rule protects nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions apply to institutions of education, issuers, and individuals, but not to governmental entities.
When first proposed in 2017, Trump administration officials said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” The U.S. Department of Health & Human Services estimates that the rules, which take effect in January 2019, will affect no more than 200 employers.
The American College of Obstetricians and Gynecologists expressed concern that the final rules will restrict patient access to meaningful contraceptive methods and will erode decades of progress in increasing women’s reproductive autonomy and restrict patient access to contraception.
“Women, families and our nation all benefit from seamless, affordable access to contraception,” ACOG President Lisa M. Hollier, MD, said in a statement. “Contraception improves women’s health and well-being, reduces unintended pregnancy, enables pregnancy spacing for safer pregnancies and deliveries, and empowers women’s engagement in the workforce and economic self-sufficiency. A woman’s employer should not determine whether or not she has this access.”
Marjorie Dannenfelser, president of Susan B. Anthony List, an anti-abortion group, praised the final rules, calling them needed protections from the burdensome Obama-era ACA abortifacient drug mandate.
“President Trump and HHS Secretary Azar delivered a huge victory for conscience rights and religious liberty in America,” Ms. Dannenfelser said in a statement. “No longer will Catholic nuns who care for the elderly poor be forced by the government to provide abortion-inducing drugs in their health care plans. Not only that, moral objectors such as Susan B. Anthony List, will also no longer have to pay for life-ending drugs that are antithetical to their mission and for which we have argued there is certainly no compelling state interest.”
The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.
However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.
Under the approved regulations, employers or insurers can stop their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. Exempted entities and individuals also can choose to cover some, but not all, contraceptive services, depending on their specific religious or moral objection, according to an HHS fact sheet.
The agency emphasized that the regulations leave in place government programs that provide free or subsidized contraceptive coverage to low-income women, such as through community health centers, and that the rules do not ban any employer from covering contraceptives.
The regulations become effective 60 days after they are published in the Federal Register.
More employers can opt out of providing contraception coverage to their employees under final regulations from the Trump administration that narrow the Affordable Care Act’s contraceptive mandate.
The two regulations, released Nov. 7, allow an expanded group of employers and insurers to get out of covering contraception methods by objecting on either religious or moral grounds.
The first rule broadens exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second rule protects nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions apply to institutions of education, issuers, and individuals, but not to governmental entities.
When first proposed in 2017, Trump administration officials said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” The U.S. Department of Health & Human Services estimates that the rules, which take effect in January 2019, will affect no more than 200 employers.
The American College of Obstetricians and Gynecologists expressed concern that the final rules will restrict patient access to meaningful contraceptive methods and will erode decades of progress in increasing women’s reproductive autonomy and restrict patient access to contraception.
“Women, families and our nation all benefit from seamless, affordable access to contraception,” ACOG President Lisa M. Hollier, MD, said in a statement. “Contraception improves women’s health and well-being, reduces unintended pregnancy, enables pregnancy spacing for safer pregnancies and deliveries, and empowers women’s engagement in the workforce and economic self-sufficiency. A woman’s employer should not determine whether or not she has this access.”
Marjorie Dannenfelser, president of Susan B. Anthony List, an anti-abortion group, praised the final rules, calling them needed protections from the burdensome Obama-era ACA abortifacient drug mandate.
“President Trump and HHS Secretary Azar delivered a huge victory for conscience rights and religious liberty in America,” Ms. Dannenfelser said in a statement. “No longer will Catholic nuns who care for the elderly poor be forced by the government to provide abortion-inducing drugs in their health care plans. Not only that, moral objectors such as Susan B. Anthony List, will also no longer have to pay for life-ending drugs that are antithetical to their mission and for which we have argued there is certainly no compelling state interest.”
The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.
However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.
Under the approved regulations, employers or insurers can stop their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. Exempted entities and individuals also can choose to cover some, but not all, contraceptive services, depending on their specific religious or moral objection, according to an HHS fact sheet.
The agency emphasized that the regulations leave in place government programs that provide free or subsidized contraceptive coverage to low-income women, such as through community health centers, and that the rules do not ban any employer from covering contraceptives.
The regulations become effective 60 days after they are published in the Federal Register.
More employers can opt out of providing contraception coverage to their employees under final regulations from the Trump administration that narrow the Affordable Care Act’s contraceptive mandate.
The two regulations, released Nov. 7, allow an expanded group of employers and insurers to get out of covering contraception methods by objecting on either religious or moral grounds.
The first rule broadens exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second rule protects nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions apply to institutions of education, issuers, and individuals, but not to governmental entities.
When first proposed in 2017, Trump administration officials said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” The U.S. Department of Health & Human Services estimates that the rules, which take effect in January 2019, will affect no more than 200 employers.
The American College of Obstetricians and Gynecologists expressed concern that the final rules will restrict patient access to meaningful contraceptive methods and will erode decades of progress in increasing women’s reproductive autonomy and restrict patient access to contraception.
“Women, families and our nation all benefit from seamless, affordable access to contraception,” ACOG President Lisa M. Hollier, MD, said in a statement. “Contraception improves women’s health and well-being, reduces unintended pregnancy, enables pregnancy spacing for safer pregnancies and deliveries, and empowers women’s engagement in the workforce and economic self-sufficiency. A woman’s employer should not determine whether or not she has this access.”
Marjorie Dannenfelser, president of Susan B. Anthony List, an anti-abortion group, praised the final rules, calling them needed protections from the burdensome Obama-era ACA abortifacient drug mandate.
“President Trump and HHS Secretary Azar delivered a huge victory for conscience rights and religious liberty in America,” Ms. Dannenfelser said in a statement. “No longer will Catholic nuns who care for the elderly poor be forced by the government to provide abortion-inducing drugs in their health care plans. Not only that, moral objectors such as Susan B. Anthony List, will also no longer have to pay for life-ending drugs that are antithetical to their mission and for which we have argued there is certainly no compelling state interest.”
The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.
However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.
Under the approved regulations, employers or insurers can stop their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. Exempted entities and individuals also can choose to cover some, but not all, contraceptive services, depending on their specific religious or moral objection, according to an HHS fact sheet.
The agency emphasized that the regulations leave in place government programs that provide free or subsidized contraceptive coverage to low-income women, such as through community health centers, and that the rules do not ban any employer from covering contraceptives.
The regulations become effective 60 days after they are published in the Federal Register.
ACR readies first-ever guidelines on managing reproductive health in rheumatology
CHICAGO – Help is on the way for rheumatologists who may feel out of their depth regarding reproductive health issues in their patients.
for internal review in draft form. Lisa R. Sammaritano, MD, a leader of the expert panel that developed the evidence-based recommendations, shared highlights of the forthcoming guidelines at the annual meeting of the American College of Rheumatology.
“Our patients, fortunately, are pursuing pregnancy more often now than in years past. One of the key messages of the guidelines is that patients really do want to discuss these topics with their rheumatologist, even though that often does not happen now. What patients told us [in the guideline-development process] is their rheumatologist knows them better than their gynecologist or any of their other doctors because we have followed them for a long period of time and we understand their disease and their symptoms. They really want our input on questions about contraception, when to plan a pregnancy, and medication use,” said Dr. Sammaritano of the Hospital for Special Surgery and Cornell University in New York.
The guidelines were created over the course of a year and a half with extensive input from ob.gyns., as well as a patient panel. The project included a systematic review of more than 300 published studies in which guideline panelists attempt to find answers to an initial list of 370 questions. Dr. Sammaritano predicted that the guidelines will prove to be useful not only for rheumatologists, but for their colleagues in ob.gyn. as well. Just as rheumatologists likely haven’t kept up with the sea changes that have occurred in ob.gyn. since their medical school days, most ob.gyns. know little about rheumatic diseases.
“There’s room for education on both sides,” she observed in an interview. “I have had to write letters to gynecologists to get them to put my patients with antiphospholipid antibodies on a contraceptive that includes a progestin because the labeling says, ‘May increase risk of thrombosis.’ And yet if you look at the literature, most of the progestins do not increase the risk of thrombosis, even in patients who are already at increased risk because of a genetic prothrombotic abnormality. I practically had to sign my life away to get a gynecologist to put a progestin-containing IUD in my patient, whereas the risk of thrombosis to my patient with an unplanned pregnancy would have been 10-fold or 100-fold higher. Unplanned pregnancy is dangerous for patients with our diseases.”
And yet, she noted, half of all pregnancies in the United States are unplanned. Among women with rheumatic diseases, the proportion may well be even higher in light of their documented low rate of utilization of effective contraception.
A publication date for the guidelines won’t be set until the review is completed, but the plan is to issue three separate documents. One will address reproductive health outside of pregnancy, with key topics to include contraception, fertility preservation, menopause, and hormone replacement therapy. The second document will focus on pregnancy management, with special attention devoted to women with lupus or antiphospholipid antibodies because they are at particularly high risk of adverse pregnancy outcomes. The third document will be devoted to medications, covering issues including which medications can be continued during pregnancy and when to safely stop the ones that can’t. This section will address both maternal and paternal use of rheumatologic medications, the latter being a topic below the radar of ob.gyns.
The three medications whose paternal use in pregnancy generate the most questions in clinical practice are methotrexate, cyclophosphamide, and sulfasalazine.
“I cannot tell you how many times I’ve been asked whether male patients with rheumatic diseases need to stop their methotrexate before they plan to father a child – that’s been a big one. The answer is they don’t need to stop, but that’s a conditional recommendation because the product label still says to stop it 3 months before. But that’s based on theoretical concerns, and all the data support a lack of teratogenicity for men using methotrexate prior to and during pregnancy,” Dr. Sammaritano said.
Men on cyclophosphamide absolutely have to stop the drug 3 months before pregnancy because the drug causes DNA fragmentation in the sperm. Sulfasalazine is known to impair male fertility. The ACR guidelines will recommend that men continue the drug, but if pregnancy doesn’t occur within a reasonable time, then it’s appropriate to get a semen analysis rather than stopping sulfasalazine unnecessarily.
American College of Obstetricians and Gynecologists guidelines now recommend long-acting reversible contraception, including IUDs and progestin implants, as first-line contraception for all women. The ACR draft guidelines strongly recommend the same.
“That is new. The use of this form of contraception in women with rheumatic diseases is quite low. In general, our patients don’t use contraception as often as other women, and when they do, they don’t use effective contraception. There are many theories as to why that may be: perhaps it’s a focus on the more immediate issues of their rheumatic disease that doesn’t allow their rheumatologist to get to the point of discussing contraception,” according to Dr. Sammaritano.
Many rheumatologists will be pleasantly surprised to learn that the problem of increased risk of pelvic inflammatory disease associated with earlier-generation IUDs is no longer an issue with the current devices. And contrary to a misconception among some ob.gyns., autoimmune disease will not cause a woman to reject her IUD.
The ACR guidelines recommend continuing hydroxychloroquine in lupus patients during pregnancy – and considering starting the drug in those not already on it – because of strong evidence supporting both safety and benefit for mother and baby.
“We are recommending the use of low-dose aspirin for patients with lupus and antiphospholipid antibodies because those two conditions increase the risk for preeclampsia, and the ob.gyns. routinely use low-dose aspirin starting toward the end of the first trimester as preventive therapy. Large studies show that it reduces the risk,” she continued.
Dr. Sammaritano cautioned that the literature on the use of rheumatologic medications in pregnancy and breast feeding is generally weak – and in the case of the new oral small molecule JAK inhibitors, essentially nonexistent.
“A lot of our recommendations are conditional because we did not feel that the data support a strong recommendation. But you have to do something. As long as you communicate the idea that we’re doing the best we can with what information is available, I think patients will respond to that,” the rheumatologist said.
She reported having no financial conflicts regarding her presentation.
CHICAGO – Help is on the way for rheumatologists who may feel out of their depth regarding reproductive health issues in their patients.
for internal review in draft form. Lisa R. Sammaritano, MD, a leader of the expert panel that developed the evidence-based recommendations, shared highlights of the forthcoming guidelines at the annual meeting of the American College of Rheumatology.
“Our patients, fortunately, are pursuing pregnancy more often now than in years past. One of the key messages of the guidelines is that patients really do want to discuss these topics with their rheumatologist, even though that often does not happen now. What patients told us [in the guideline-development process] is their rheumatologist knows them better than their gynecologist or any of their other doctors because we have followed them for a long period of time and we understand their disease and their symptoms. They really want our input on questions about contraception, when to plan a pregnancy, and medication use,” said Dr. Sammaritano of the Hospital for Special Surgery and Cornell University in New York.
The guidelines were created over the course of a year and a half with extensive input from ob.gyns., as well as a patient panel. The project included a systematic review of more than 300 published studies in which guideline panelists attempt to find answers to an initial list of 370 questions. Dr. Sammaritano predicted that the guidelines will prove to be useful not only for rheumatologists, but for their colleagues in ob.gyn. as well. Just as rheumatologists likely haven’t kept up with the sea changes that have occurred in ob.gyn. since their medical school days, most ob.gyns. know little about rheumatic diseases.
“There’s room for education on both sides,” she observed in an interview. “I have had to write letters to gynecologists to get them to put my patients with antiphospholipid antibodies on a contraceptive that includes a progestin because the labeling says, ‘May increase risk of thrombosis.’ And yet if you look at the literature, most of the progestins do not increase the risk of thrombosis, even in patients who are already at increased risk because of a genetic prothrombotic abnormality. I practically had to sign my life away to get a gynecologist to put a progestin-containing IUD in my patient, whereas the risk of thrombosis to my patient with an unplanned pregnancy would have been 10-fold or 100-fold higher. Unplanned pregnancy is dangerous for patients with our diseases.”
And yet, she noted, half of all pregnancies in the United States are unplanned. Among women with rheumatic diseases, the proportion may well be even higher in light of their documented low rate of utilization of effective contraception.
A publication date for the guidelines won’t be set until the review is completed, but the plan is to issue three separate documents. One will address reproductive health outside of pregnancy, with key topics to include contraception, fertility preservation, menopause, and hormone replacement therapy. The second document will focus on pregnancy management, with special attention devoted to women with lupus or antiphospholipid antibodies because they are at particularly high risk of adverse pregnancy outcomes. The third document will be devoted to medications, covering issues including which medications can be continued during pregnancy and when to safely stop the ones that can’t. This section will address both maternal and paternal use of rheumatologic medications, the latter being a topic below the radar of ob.gyns.
The three medications whose paternal use in pregnancy generate the most questions in clinical practice are methotrexate, cyclophosphamide, and sulfasalazine.
“I cannot tell you how many times I’ve been asked whether male patients with rheumatic diseases need to stop their methotrexate before they plan to father a child – that’s been a big one. The answer is they don’t need to stop, but that’s a conditional recommendation because the product label still says to stop it 3 months before. But that’s based on theoretical concerns, and all the data support a lack of teratogenicity for men using methotrexate prior to and during pregnancy,” Dr. Sammaritano said.
Men on cyclophosphamide absolutely have to stop the drug 3 months before pregnancy because the drug causes DNA fragmentation in the sperm. Sulfasalazine is known to impair male fertility. The ACR guidelines will recommend that men continue the drug, but if pregnancy doesn’t occur within a reasonable time, then it’s appropriate to get a semen analysis rather than stopping sulfasalazine unnecessarily.
American College of Obstetricians and Gynecologists guidelines now recommend long-acting reversible contraception, including IUDs and progestin implants, as first-line contraception for all women. The ACR draft guidelines strongly recommend the same.
“That is new. The use of this form of contraception in women with rheumatic diseases is quite low. In general, our patients don’t use contraception as often as other women, and when they do, they don’t use effective contraception. There are many theories as to why that may be: perhaps it’s a focus on the more immediate issues of their rheumatic disease that doesn’t allow their rheumatologist to get to the point of discussing contraception,” according to Dr. Sammaritano.
Many rheumatologists will be pleasantly surprised to learn that the problem of increased risk of pelvic inflammatory disease associated with earlier-generation IUDs is no longer an issue with the current devices. And contrary to a misconception among some ob.gyns., autoimmune disease will not cause a woman to reject her IUD.
The ACR guidelines recommend continuing hydroxychloroquine in lupus patients during pregnancy – and considering starting the drug in those not already on it – because of strong evidence supporting both safety and benefit for mother and baby.
“We are recommending the use of low-dose aspirin for patients with lupus and antiphospholipid antibodies because those two conditions increase the risk for preeclampsia, and the ob.gyns. routinely use low-dose aspirin starting toward the end of the first trimester as preventive therapy. Large studies show that it reduces the risk,” she continued.
Dr. Sammaritano cautioned that the literature on the use of rheumatologic medications in pregnancy and breast feeding is generally weak – and in the case of the new oral small molecule JAK inhibitors, essentially nonexistent.
“A lot of our recommendations are conditional because we did not feel that the data support a strong recommendation. But you have to do something. As long as you communicate the idea that we’re doing the best we can with what information is available, I think patients will respond to that,” the rheumatologist said.
She reported having no financial conflicts regarding her presentation.
CHICAGO – Help is on the way for rheumatologists who may feel out of their depth regarding reproductive health issues in their patients.
for internal review in draft form. Lisa R. Sammaritano, MD, a leader of the expert panel that developed the evidence-based recommendations, shared highlights of the forthcoming guidelines at the annual meeting of the American College of Rheumatology.
“Our patients, fortunately, are pursuing pregnancy more often now than in years past. One of the key messages of the guidelines is that patients really do want to discuss these topics with their rheumatologist, even though that often does not happen now. What patients told us [in the guideline-development process] is their rheumatologist knows them better than their gynecologist or any of their other doctors because we have followed them for a long period of time and we understand their disease and their symptoms. They really want our input on questions about contraception, when to plan a pregnancy, and medication use,” said Dr. Sammaritano of the Hospital for Special Surgery and Cornell University in New York.
The guidelines were created over the course of a year and a half with extensive input from ob.gyns., as well as a patient panel. The project included a systematic review of more than 300 published studies in which guideline panelists attempt to find answers to an initial list of 370 questions. Dr. Sammaritano predicted that the guidelines will prove to be useful not only for rheumatologists, but for their colleagues in ob.gyn. as well. Just as rheumatologists likely haven’t kept up with the sea changes that have occurred in ob.gyn. since their medical school days, most ob.gyns. know little about rheumatic diseases.
“There’s room for education on both sides,” she observed in an interview. “I have had to write letters to gynecologists to get them to put my patients with antiphospholipid antibodies on a contraceptive that includes a progestin because the labeling says, ‘May increase risk of thrombosis.’ And yet if you look at the literature, most of the progestins do not increase the risk of thrombosis, even in patients who are already at increased risk because of a genetic prothrombotic abnormality. I practically had to sign my life away to get a gynecologist to put a progestin-containing IUD in my patient, whereas the risk of thrombosis to my patient with an unplanned pregnancy would have been 10-fold or 100-fold higher. Unplanned pregnancy is dangerous for patients with our diseases.”
And yet, she noted, half of all pregnancies in the United States are unplanned. Among women with rheumatic diseases, the proportion may well be even higher in light of their documented low rate of utilization of effective contraception.
A publication date for the guidelines won’t be set until the review is completed, but the plan is to issue three separate documents. One will address reproductive health outside of pregnancy, with key topics to include contraception, fertility preservation, menopause, and hormone replacement therapy. The second document will focus on pregnancy management, with special attention devoted to women with lupus or antiphospholipid antibodies because they are at particularly high risk of adverse pregnancy outcomes. The third document will be devoted to medications, covering issues including which medications can be continued during pregnancy and when to safely stop the ones that can’t. This section will address both maternal and paternal use of rheumatologic medications, the latter being a topic below the radar of ob.gyns.
The three medications whose paternal use in pregnancy generate the most questions in clinical practice are methotrexate, cyclophosphamide, and sulfasalazine.
“I cannot tell you how many times I’ve been asked whether male patients with rheumatic diseases need to stop their methotrexate before they plan to father a child – that’s been a big one. The answer is they don’t need to stop, but that’s a conditional recommendation because the product label still says to stop it 3 months before. But that’s based on theoretical concerns, and all the data support a lack of teratogenicity for men using methotrexate prior to and during pregnancy,” Dr. Sammaritano said.
Men on cyclophosphamide absolutely have to stop the drug 3 months before pregnancy because the drug causes DNA fragmentation in the sperm. Sulfasalazine is known to impair male fertility. The ACR guidelines will recommend that men continue the drug, but if pregnancy doesn’t occur within a reasonable time, then it’s appropriate to get a semen analysis rather than stopping sulfasalazine unnecessarily.
American College of Obstetricians and Gynecologists guidelines now recommend long-acting reversible contraception, including IUDs and progestin implants, as first-line contraception for all women. The ACR draft guidelines strongly recommend the same.
“That is new. The use of this form of contraception in women with rheumatic diseases is quite low. In general, our patients don’t use contraception as often as other women, and when they do, they don’t use effective contraception. There are many theories as to why that may be: perhaps it’s a focus on the more immediate issues of their rheumatic disease that doesn’t allow their rheumatologist to get to the point of discussing contraception,” according to Dr. Sammaritano.
Many rheumatologists will be pleasantly surprised to learn that the problem of increased risk of pelvic inflammatory disease associated with earlier-generation IUDs is no longer an issue with the current devices. And contrary to a misconception among some ob.gyns., autoimmune disease will not cause a woman to reject her IUD.
The ACR guidelines recommend continuing hydroxychloroquine in lupus patients during pregnancy – and considering starting the drug in those not already on it – because of strong evidence supporting both safety and benefit for mother and baby.
“We are recommending the use of low-dose aspirin for patients with lupus and antiphospholipid antibodies because those two conditions increase the risk for preeclampsia, and the ob.gyns. routinely use low-dose aspirin starting toward the end of the first trimester as preventive therapy. Large studies show that it reduces the risk,” she continued.
Dr. Sammaritano cautioned that the literature on the use of rheumatologic medications in pregnancy and breast feeding is generally weak – and in the case of the new oral small molecule JAK inhibitors, essentially nonexistent.
“A lot of our recommendations are conditional because we did not feel that the data support a strong recommendation. But you have to do something. As long as you communicate the idea that we’re doing the best we can with what information is available, I think patients will respond to that,” the rheumatologist said.
She reported having no financial conflicts regarding her presentation.
REPORTING FROM THE ACR ANNUAL MEETING