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Ectopic pregnancy risk and levonorgestrel-releasing IUDs
Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.
A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).
The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.
“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.
“Ectopic pregnancy is an acknowledged adverse event of hormonal IUD use. Although a rare event, it is a serious one, and a difference in ectopic pregnancy safety between the two low-dose hormonal IUDs would impact my recommendations to women.”
The study
Dr. Meaidi’s group followed 963,964 women for 7.8 million person-years. For users of levonorgestrel IUS dosages 52 mg, 19.5 mg, and 13.5 mg, and other hormonal contraceptives, the median ages were 24, 22, 22, and 21 years, respectively.
Eligible women were nulliparous with no previous ectopic pregnancy, abdominal or pelvic surgery, infertility treatment, endometriosis, or use of a levonorgestrel IUS. They were followed from Jan. 1, 2001, or their 15th birthday, until July 1, 2021, age 35, pregnancy, death, emigration, or the occurrence of any exclusion criterion.
During the study period, the cohort registered 2,925 ectopic pregnancies, including 35 at 52 mg, 32 at 19.5 mg, and 80 at 13.5 mg of levonorgestrel. For all other types of hormonal contraception, there were 763 ectopic pregnancies.
In terms of adjusted absolute rates of ectopic pregnancy per 10,000 person-years, compared with other hormonal contraceptives (rate = 2.4), these were 7.7 with 52 mg levonorgestrel IUS, 7.1 with 19.5 mg, and 15.7 with 13.5 mg. They translated to comparative differences of 5.3 (95% confidence interval, 1.9-8.7), 4.8 (95% CI, 1.5-8.0), and 13.4 (95% CI, 8.8-18.1), respectively.
Corresponding adjusted relative rate ratios were 3.4, 4.1, and 7.9. For each levonorgestrel IUS dosage; the ectopic pregnancy rate increased with duration of use.
The adjusted ectopic pregnancy rate difference per 10,000 person-years between the 19.5-mg and 52-mg levonorgestrel dosages was −0.6 , and between the 13.5-mg and 52-mg doses, 8.0, with a rate ratio of 2.3. The rate difference between the 13.5-mg and 19.5-mg levonorgestrel IUS was 8.6, with a rate ratio of 1.9.
An outsider’s perspective
Offering an outsider’s perspective on the study, Eran Bornstein, MD, vice-chair of obstetrics and gynecology at Lenox Hill Hospital in New York, said these data should spark further evaluation of risk of ectopic pregnancy with levonorgestrel-releasing IUDs. “The best advice for clinicians is to individualize the choice of which contraceptive to use, and when levonorgestrel IUD is selected, to individualize the appropriate dose and timing of placement,” he said in an interview.
Several additional factors may determine the best choice, Dr. Bornstein added, including medical conditions that contraindicate other contraceptives and those conditions that justify avoidance of pregnancy, as well as uterine myomas or malformation, the ability of the patient to comply with other options, and informed patient choice. “It is important to remember the potential risk for expulsion and ectopic pregnancy, maintain alertness, and use ultrasound to exclude these potential complications if suspected,” he said.
Dr. Meaidi said the mechanism of ectopic pregnancy with hormonal IUDs is unclear, but in vitro and animal studies have observed that levonorgestrel reduces the ciliary beat frequency in the fallopian tubes. “Thus, it could be hypothesized that if a woman was unfortunate enough to become pregnant using a hormonal IUD, the hormone could inhibit or slow down the movement of the zygote into the uterus for rightful intrauterine implantation and thereby increase the risk of ectopic pregnancy.”
Two coauthors of the study reported financial support from private-sector companies. Dr. Meaidi had no conflicts of interest. Dr. Bornstein disclosed no competing interests.
Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.
A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).
The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.
“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.
“Ectopic pregnancy is an acknowledged adverse event of hormonal IUD use. Although a rare event, it is a serious one, and a difference in ectopic pregnancy safety between the two low-dose hormonal IUDs would impact my recommendations to women.”
The study
Dr. Meaidi’s group followed 963,964 women for 7.8 million person-years. For users of levonorgestrel IUS dosages 52 mg, 19.5 mg, and 13.5 mg, and other hormonal contraceptives, the median ages were 24, 22, 22, and 21 years, respectively.
Eligible women were nulliparous with no previous ectopic pregnancy, abdominal or pelvic surgery, infertility treatment, endometriosis, or use of a levonorgestrel IUS. They were followed from Jan. 1, 2001, or their 15th birthday, until July 1, 2021, age 35, pregnancy, death, emigration, or the occurrence of any exclusion criterion.
During the study period, the cohort registered 2,925 ectopic pregnancies, including 35 at 52 mg, 32 at 19.5 mg, and 80 at 13.5 mg of levonorgestrel. For all other types of hormonal contraception, there were 763 ectopic pregnancies.
In terms of adjusted absolute rates of ectopic pregnancy per 10,000 person-years, compared with other hormonal contraceptives (rate = 2.4), these were 7.7 with 52 mg levonorgestrel IUS, 7.1 with 19.5 mg, and 15.7 with 13.5 mg. They translated to comparative differences of 5.3 (95% confidence interval, 1.9-8.7), 4.8 (95% CI, 1.5-8.0), and 13.4 (95% CI, 8.8-18.1), respectively.
Corresponding adjusted relative rate ratios were 3.4, 4.1, and 7.9. For each levonorgestrel IUS dosage; the ectopic pregnancy rate increased with duration of use.
The adjusted ectopic pregnancy rate difference per 10,000 person-years between the 19.5-mg and 52-mg levonorgestrel dosages was −0.6 , and between the 13.5-mg and 52-mg doses, 8.0, with a rate ratio of 2.3. The rate difference between the 13.5-mg and 19.5-mg levonorgestrel IUS was 8.6, with a rate ratio of 1.9.
An outsider’s perspective
Offering an outsider’s perspective on the study, Eran Bornstein, MD, vice-chair of obstetrics and gynecology at Lenox Hill Hospital in New York, said these data should spark further evaluation of risk of ectopic pregnancy with levonorgestrel-releasing IUDs. “The best advice for clinicians is to individualize the choice of which contraceptive to use, and when levonorgestrel IUD is selected, to individualize the appropriate dose and timing of placement,” he said in an interview.
Several additional factors may determine the best choice, Dr. Bornstein added, including medical conditions that contraindicate other contraceptives and those conditions that justify avoidance of pregnancy, as well as uterine myomas or malformation, the ability of the patient to comply with other options, and informed patient choice. “It is important to remember the potential risk for expulsion and ectopic pregnancy, maintain alertness, and use ultrasound to exclude these potential complications if suspected,” he said.
Dr. Meaidi said the mechanism of ectopic pregnancy with hormonal IUDs is unclear, but in vitro and animal studies have observed that levonorgestrel reduces the ciliary beat frequency in the fallopian tubes. “Thus, it could be hypothesized that if a woman was unfortunate enough to become pregnant using a hormonal IUD, the hormone could inhibit or slow down the movement of the zygote into the uterus for rightful intrauterine implantation and thereby increase the risk of ectopic pregnancy.”
Two coauthors of the study reported financial support from private-sector companies. Dr. Meaidi had no conflicts of interest. Dr. Bornstein disclosed no competing interests.
Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.
A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).
The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.
“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.
“Ectopic pregnancy is an acknowledged adverse event of hormonal IUD use. Although a rare event, it is a serious one, and a difference in ectopic pregnancy safety between the two low-dose hormonal IUDs would impact my recommendations to women.”
The study
Dr. Meaidi’s group followed 963,964 women for 7.8 million person-years. For users of levonorgestrel IUS dosages 52 mg, 19.5 mg, and 13.5 mg, and other hormonal contraceptives, the median ages were 24, 22, 22, and 21 years, respectively.
Eligible women were nulliparous with no previous ectopic pregnancy, abdominal or pelvic surgery, infertility treatment, endometriosis, or use of a levonorgestrel IUS. They were followed from Jan. 1, 2001, or their 15th birthday, until July 1, 2021, age 35, pregnancy, death, emigration, or the occurrence of any exclusion criterion.
During the study period, the cohort registered 2,925 ectopic pregnancies, including 35 at 52 mg, 32 at 19.5 mg, and 80 at 13.5 mg of levonorgestrel. For all other types of hormonal contraception, there were 763 ectopic pregnancies.
In terms of adjusted absolute rates of ectopic pregnancy per 10,000 person-years, compared with other hormonal contraceptives (rate = 2.4), these were 7.7 with 52 mg levonorgestrel IUS, 7.1 with 19.5 mg, and 15.7 with 13.5 mg. They translated to comparative differences of 5.3 (95% confidence interval, 1.9-8.7), 4.8 (95% CI, 1.5-8.0), and 13.4 (95% CI, 8.8-18.1), respectively.
Corresponding adjusted relative rate ratios were 3.4, 4.1, and 7.9. For each levonorgestrel IUS dosage; the ectopic pregnancy rate increased with duration of use.
The adjusted ectopic pregnancy rate difference per 10,000 person-years between the 19.5-mg and 52-mg levonorgestrel dosages was −0.6 , and between the 13.5-mg and 52-mg doses, 8.0, with a rate ratio of 2.3. The rate difference between the 13.5-mg and 19.5-mg levonorgestrel IUS was 8.6, with a rate ratio of 1.9.
An outsider’s perspective
Offering an outsider’s perspective on the study, Eran Bornstein, MD, vice-chair of obstetrics and gynecology at Lenox Hill Hospital in New York, said these data should spark further evaluation of risk of ectopic pregnancy with levonorgestrel-releasing IUDs. “The best advice for clinicians is to individualize the choice of which contraceptive to use, and when levonorgestrel IUD is selected, to individualize the appropriate dose and timing of placement,” he said in an interview.
Several additional factors may determine the best choice, Dr. Bornstein added, including medical conditions that contraindicate other contraceptives and those conditions that justify avoidance of pregnancy, as well as uterine myomas or malformation, the ability of the patient to comply with other options, and informed patient choice. “It is important to remember the potential risk for expulsion and ectopic pregnancy, maintain alertness, and use ultrasound to exclude these potential complications if suspected,” he said.
Dr. Meaidi said the mechanism of ectopic pregnancy with hormonal IUDs is unclear, but in vitro and animal studies have observed that levonorgestrel reduces the ciliary beat frequency in the fallopian tubes. “Thus, it could be hypothesized that if a woman was unfortunate enough to become pregnant using a hormonal IUD, the hormone could inhibit or slow down the movement of the zygote into the uterus for rightful intrauterine implantation and thereby increase the risk of ectopic pregnancy.”
Two coauthors of the study reported financial support from private-sector companies. Dr. Meaidi had no conflicts of interest. Dr. Bornstein disclosed no competing interests.
FROM JAMA
The human-looking robot therapist will coach your well-being now
Do android therapists dream of electric employees?
Robots. It can be tough to remember that, when they’re not dooming humanity to apocalypse or just telling you that you’re doomed, robots have real-world uses. There are actual robots in the world, and they can do things beyond bend girders, sing about science, or run the navy.
Look, we’ll stop with the pop-culture references when pop culture runs out of robots to reference. It may take a while.
Robots are indelibly rooted in the public consciousness, and that plays into our expectations when we encounter a real-life robot. This leads us into a recent study conducted by researchers at the University of Cambridge, who developed a robot-led mental well-being program that a tech company utilized for 4 weeks. Why choose a robot? Well, why spring for a qualified therapist who requires a salary when you could simply get a robot to do the job for free? Get with the capitalist agenda here. Surely it won’t backfire.
The 26 people enrolled in the study received coaching from one of two robots, both programmed identically to act like mental health coaches, based on interviews with human therapists. Both acted identically and had identical expressions. The only difference between the two was their appearance. QTRobot was nearly a meter tall and looked like a human child; Misty II was much smaller and looked like a toy.
People who received coaching from Misty II were better able to connect and had a better experience than those who received coaching from QTRobot. According to those in the QTRobot group, their expectations didn’t match reality. The robots are good coaches, but they don’t act human. This wasn’t a problem for Misty II, since it doesn’t look human, but for QTRobot, the participants were expecting “to hell with our orders,” but received “Daisy, Daisy, give me your answer do.” When you’ve been programmed to think of robots as metal humans, it can be off-putting to see them act as, well, robots.
That said, all participants found the exercises helpful and were open to receiving more robot-led therapy in the future. And while we’re sure the technology will advance to make robot therapists more empathetic and more human, hopefully scientists won’t go too far. We don’t need depressed robots.
Birthing experience is all in the mindset
Alexa, play Peer Gynt Suite No. 1, Op. 46 - I. Morning Mood.
Birth.
Giving birth is a common experience for many, if not most, female mammals, but wanting it to be a pleasurable one seems distinctly human. There are many methods and practices that may make giving birth an easier and enjoyable experience for the mother, but a new study suggests that the key could be in her mind.
The mindset of the expectant mother during pregnancy, it seems, has some effect on how smooth or intervention-filled delivery is. If the mothers saw their experience as a natural process, they were less likely to need pain medication or a C-section, but mothers who viewed the experience as more of a “medical procedure” were more likely to require more medical supervision and intervention, according to investigators from the University of Bonn (Germany).
Now, the researchers wanted to be super clear in saying that there’s no right or wrong mindset to have. They just focused on the outcomes of those mindsets and whether they actually do have some effect on occurrences.
Apparently, yes.
“Mindsets can be understood as a kind of mental lense that guide our perception of the world around us and can influence our behavior,” Dr. Lisa Hoffmann said in a statement from the university. “The study highlights the importance of psychological factors in childbirth.”
The researchers surveyed 300 women with an online tool before and after delivery and found the effects of the natural process mindset lingered even after giving birth. They had lower rates of depression and posttraumatic stress, which may have a snowballing effect on mother-child bonding after childbirth.
Preparation for the big day, then, should be about more than gathering diapers and shopping for car seats. Women should prepare their minds as well. If it’s going to make giving birth better, why not?
Becoming a parent is going to create a psychological shift, no matter how you slice it.
Giant inflatable colon reported in Utah
Do not be alarmed! Yes, there is a giant inflatable colon currently at large in the Beehive State, but it will not harm you. The giant inflatable colon is in Utah as part of Intermountain Health’s “Let’s get to the bottom of colon cancer tour” and he only wants to help you.
The giant inflatable colon, whose name happens to be Collin, is 12 feet long and weighs 113 pounds. March is Colon Cancer Awareness Month, so Collin is traveling around Utah and Idaho to raise awareness about colon cancer and the various screening options. He is not going to change local weather patterns, eat small children, or take over local governments and raise your taxes.
Instead, Collin is planning to display “portions of a healthy colon, polyps or bumps on the colon, malignant polyps which look more vascular and have more redness, cancerous cells, advanced cancer cells, and Crohn’s disease,” KSL.com said.
Collin the colon is on loan to Intermountain Health from medical device manufacturer Boston Scientific and will be traveling to Spanish Fork, Provo, and Ogden, among other locations in Utah, as well as Burley and Meridian, Idaho, in the coming days.
Collin the colon’s participation in the tour has created some serious buzz in the Colin/Collin community:
- Colin Powell (four-star general and Secretary of State): “Back then, the second-most important topic among the Joint Chiefs of Staff was colon cancer screening. And the Navy guy – I can’t remember his name – was a huge fan of giant inflatable organs.”
- Colin Jost (comedian and Saturday Night Live “Weekend Update” cohost): “He’s funnier than Tucker Carlson and Pete Davidson combined.”
Do android therapists dream of electric employees?
Robots. It can be tough to remember that, when they’re not dooming humanity to apocalypse or just telling you that you’re doomed, robots have real-world uses. There are actual robots in the world, and they can do things beyond bend girders, sing about science, or run the navy.
Look, we’ll stop with the pop-culture references when pop culture runs out of robots to reference. It may take a while.
Robots are indelibly rooted in the public consciousness, and that plays into our expectations when we encounter a real-life robot. This leads us into a recent study conducted by researchers at the University of Cambridge, who developed a robot-led mental well-being program that a tech company utilized for 4 weeks. Why choose a robot? Well, why spring for a qualified therapist who requires a salary when you could simply get a robot to do the job for free? Get with the capitalist agenda here. Surely it won’t backfire.
The 26 people enrolled in the study received coaching from one of two robots, both programmed identically to act like mental health coaches, based on interviews with human therapists. Both acted identically and had identical expressions. The only difference between the two was their appearance. QTRobot was nearly a meter tall and looked like a human child; Misty II was much smaller and looked like a toy.
People who received coaching from Misty II were better able to connect and had a better experience than those who received coaching from QTRobot. According to those in the QTRobot group, their expectations didn’t match reality. The robots are good coaches, but they don’t act human. This wasn’t a problem for Misty II, since it doesn’t look human, but for QTRobot, the participants were expecting “to hell with our orders,” but received “Daisy, Daisy, give me your answer do.” When you’ve been programmed to think of robots as metal humans, it can be off-putting to see them act as, well, robots.
That said, all participants found the exercises helpful and were open to receiving more robot-led therapy in the future. And while we’re sure the technology will advance to make robot therapists more empathetic and more human, hopefully scientists won’t go too far. We don’t need depressed robots.
Birthing experience is all in the mindset
Alexa, play Peer Gynt Suite No. 1, Op. 46 - I. Morning Mood.
Birth.
Giving birth is a common experience for many, if not most, female mammals, but wanting it to be a pleasurable one seems distinctly human. There are many methods and practices that may make giving birth an easier and enjoyable experience for the mother, but a new study suggests that the key could be in her mind.
The mindset of the expectant mother during pregnancy, it seems, has some effect on how smooth or intervention-filled delivery is. If the mothers saw their experience as a natural process, they were less likely to need pain medication or a C-section, but mothers who viewed the experience as more of a “medical procedure” were more likely to require more medical supervision and intervention, according to investigators from the University of Bonn (Germany).
Now, the researchers wanted to be super clear in saying that there’s no right or wrong mindset to have. They just focused on the outcomes of those mindsets and whether they actually do have some effect on occurrences.
Apparently, yes.
“Mindsets can be understood as a kind of mental lense that guide our perception of the world around us and can influence our behavior,” Dr. Lisa Hoffmann said in a statement from the university. “The study highlights the importance of psychological factors in childbirth.”
The researchers surveyed 300 women with an online tool before and after delivery and found the effects of the natural process mindset lingered even after giving birth. They had lower rates of depression and posttraumatic stress, which may have a snowballing effect on mother-child bonding after childbirth.
Preparation for the big day, then, should be about more than gathering diapers and shopping for car seats. Women should prepare their minds as well. If it’s going to make giving birth better, why not?
Becoming a parent is going to create a psychological shift, no matter how you slice it.
Giant inflatable colon reported in Utah
Do not be alarmed! Yes, there is a giant inflatable colon currently at large in the Beehive State, but it will not harm you. The giant inflatable colon is in Utah as part of Intermountain Health’s “Let’s get to the bottom of colon cancer tour” and he only wants to help you.
The giant inflatable colon, whose name happens to be Collin, is 12 feet long and weighs 113 pounds. March is Colon Cancer Awareness Month, so Collin is traveling around Utah and Idaho to raise awareness about colon cancer and the various screening options. He is not going to change local weather patterns, eat small children, or take over local governments and raise your taxes.
Instead, Collin is planning to display “portions of a healthy colon, polyps or bumps on the colon, malignant polyps which look more vascular and have more redness, cancerous cells, advanced cancer cells, and Crohn’s disease,” KSL.com said.
Collin the colon is on loan to Intermountain Health from medical device manufacturer Boston Scientific and will be traveling to Spanish Fork, Provo, and Ogden, among other locations in Utah, as well as Burley and Meridian, Idaho, in the coming days.
Collin the colon’s participation in the tour has created some serious buzz in the Colin/Collin community:
- Colin Powell (four-star general and Secretary of State): “Back then, the second-most important topic among the Joint Chiefs of Staff was colon cancer screening. And the Navy guy – I can’t remember his name – was a huge fan of giant inflatable organs.”
- Colin Jost (comedian and Saturday Night Live “Weekend Update” cohost): “He’s funnier than Tucker Carlson and Pete Davidson combined.”
Do android therapists dream of electric employees?
Robots. It can be tough to remember that, when they’re not dooming humanity to apocalypse or just telling you that you’re doomed, robots have real-world uses. There are actual robots in the world, and they can do things beyond bend girders, sing about science, or run the navy.
Look, we’ll stop with the pop-culture references when pop culture runs out of robots to reference. It may take a while.
Robots are indelibly rooted in the public consciousness, and that plays into our expectations when we encounter a real-life robot. This leads us into a recent study conducted by researchers at the University of Cambridge, who developed a robot-led mental well-being program that a tech company utilized for 4 weeks. Why choose a robot? Well, why spring for a qualified therapist who requires a salary when you could simply get a robot to do the job for free? Get with the capitalist agenda here. Surely it won’t backfire.
The 26 people enrolled in the study received coaching from one of two robots, both programmed identically to act like mental health coaches, based on interviews with human therapists. Both acted identically and had identical expressions. The only difference between the two was their appearance. QTRobot was nearly a meter tall and looked like a human child; Misty II was much smaller and looked like a toy.
People who received coaching from Misty II were better able to connect and had a better experience than those who received coaching from QTRobot. According to those in the QTRobot group, their expectations didn’t match reality. The robots are good coaches, but they don’t act human. This wasn’t a problem for Misty II, since it doesn’t look human, but for QTRobot, the participants were expecting “to hell with our orders,” but received “Daisy, Daisy, give me your answer do.” When you’ve been programmed to think of robots as metal humans, it can be off-putting to see them act as, well, robots.
That said, all participants found the exercises helpful and were open to receiving more robot-led therapy in the future. And while we’re sure the technology will advance to make robot therapists more empathetic and more human, hopefully scientists won’t go too far. We don’t need depressed robots.
Birthing experience is all in the mindset
Alexa, play Peer Gynt Suite No. 1, Op. 46 - I. Morning Mood.
Birth.
Giving birth is a common experience for many, if not most, female mammals, but wanting it to be a pleasurable one seems distinctly human. There are many methods and practices that may make giving birth an easier and enjoyable experience for the mother, but a new study suggests that the key could be in her mind.
The mindset of the expectant mother during pregnancy, it seems, has some effect on how smooth or intervention-filled delivery is. If the mothers saw their experience as a natural process, they were less likely to need pain medication or a C-section, but mothers who viewed the experience as more of a “medical procedure” were more likely to require more medical supervision and intervention, according to investigators from the University of Bonn (Germany).
Now, the researchers wanted to be super clear in saying that there’s no right or wrong mindset to have. They just focused on the outcomes of those mindsets and whether they actually do have some effect on occurrences.
Apparently, yes.
“Mindsets can be understood as a kind of mental lense that guide our perception of the world around us and can influence our behavior,” Dr. Lisa Hoffmann said in a statement from the university. “The study highlights the importance of psychological factors in childbirth.”
The researchers surveyed 300 women with an online tool before and after delivery and found the effects of the natural process mindset lingered even after giving birth. They had lower rates of depression and posttraumatic stress, which may have a snowballing effect on mother-child bonding after childbirth.
Preparation for the big day, then, should be about more than gathering diapers and shopping for car seats. Women should prepare their minds as well. If it’s going to make giving birth better, why not?
Becoming a parent is going to create a psychological shift, no matter how you slice it.
Giant inflatable colon reported in Utah
Do not be alarmed! Yes, there is a giant inflatable colon currently at large in the Beehive State, but it will not harm you. The giant inflatable colon is in Utah as part of Intermountain Health’s “Let’s get to the bottom of colon cancer tour” and he only wants to help you.
The giant inflatable colon, whose name happens to be Collin, is 12 feet long and weighs 113 pounds. March is Colon Cancer Awareness Month, so Collin is traveling around Utah and Idaho to raise awareness about colon cancer and the various screening options. He is not going to change local weather patterns, eat small children, or take over local governments and raise your taxes.
Instead, Collin is planning to display “portions of a healthy colon, polyps or bumps on the colon, malignant polyps which look more vascular and have more redness, cancerous cells, advanced cancer cells, and Crohn’s disease,” KSL.com said.
Collin the colon is on loan to Intermountain Health from medical device manufacturer Boston Scientific and will be traveling to Spanish Fork, Provo, and Ogden, among other locations in Utah, as well as Burley and Meridian, Idaho, in the coming days.
Collin the colon’s participation in the tour has created some serious buzz in the Colin/Collin community:
- Colin Powell (four-star general and Secretary of State): “Back then, the second-most important topic among the Joint Chiefs of Staff was colon cancer screening. And the Navy guy – I can’t remember his name – was a huge fan of giant inflatable organs.”
- Colin Jost (comedian and Saturday Night Live “Weekend Update” cohost): “He’s funnier than Tucker Carlson and Pete Davidson combined.”
Opioid overdose is an important cause of postpartum death
(OUD), according to research published in Obstetrics and Gynecology.
Opioid overdose deaths account for up to 10% of pregnancy-associated deaths in the United States, and 75% of the deliveries of women with OUD are covered by Medicaid, according to lead author Elizabeth Suarez, PhD, MPH, with the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
Nearly 5 million deliveries studied
Researchers studied claims data from Medicaid and the National Death Index database in the United States from 2006 to 2013 for 4,972,061 deliveries. They also identified a subgroup of women with a documented history of OUD in the 3 months before delivery.
They found the incidence of postpartum opioid overdose deaths was 5.4 per 100,000 deliveries (95% confidence interval, 4.5-6.4) among all in the study and 118 per 100,000 (95% CI, 84-163) among individuals with OUD.
Incidence of all-cause postpartum death was six times higher in women with OUD than in all the women studied. Common causes of death of those with OUD were other drug- and alcohol-related deaths (47/100,000); suicide (26/100,000); and other injuries, including accidents and falls (33/100,000).
Risk factors strongly linked with postpartum opioid overdose death included mental health and other substance use disorders.
Medication significantly lowers death risk
The authors also documented the benefit of buprenorphine or methadone for OUD.
For women with OUD who used medication to treat OUD post partum, odds of opioid overdose death were 60% lower (odds ratio, 0.4; 95% CI 0.1-0.9).
As important as use of medication, Marcela Smid, MD, MS, writes in an accompanying editorial, is noting that 80% of the women in this study who died of opioid overdoses had contact with a health care provider before death.
“Both of these results indicate that we have the means and opportunity to prevent these deaths,” writes Dr. Smid, with the division of maternal fetal medicine, University of Utah Health in Salt Lake City.
Dismal numbers on ob.gyns. trained to prescribe medications
She points out some barriers, however. Most clinicians, she notes, lack time and training to prescribe buprenorphine, and in 2019, fewer than 2% of ob.gyns. who accept Medicaid were able to prescribe it.
Her charge to ob.gyns.: “We need to help identify individuals who are at high risk of OUD or opioid overdose by screening.” A validated screening tool should be used at prenatal and postpartum appointments.
On a bigger scale, she urges Medicaid to be expanded for a full year post partum through the American Rescue Act’s State Plan Amendment, something only 28 states and Washington, D.C., have done so far.
Dr. Smid points out some good news, however: President Joe Biden signed the Consolidated Appropriations Act 2023, which eliminated the “X” waiver.
Now all clinicians who have a Drug Enforcement Administration registration that includes Schedule III authority can prescribe buprenorphine for OUD if applicable state law allows it.
But that calls for medical schools and residency programs to prioritize addiction medicine as a core competency, Dr. Smid says.
Getting naloxone to patients, families
One of the potential interventions the study authors suggest is providing naloxone prescriptions and training to pregnant and postpartum women who have a substance use history and to their partners and significant others.
However, Mishka Terplan, MD, MPH, told this publication, “It’s one thing to write a prescription; it’s another thing for the person to actually get the medication.” He is medical director of the Friends Research Institute in Baltimore, an ob.gyn. who specializes in addiction medicine.
“What can we do?” We can think about how to get naloxone into people’s hands at discharge from the hospital after they give birth, instead of prescribing. That would mean that health systems need to prioritize this, he said. “We give people discharge medications all the time.”
Still, naloxone can’t be seen as the answer, he said.
He compares it to defibrillators in public places, which are for rescues, not reversing a population problem.
“Some people think that naloxone reversals are doing something about OUD. It’s doing about as much about OUD as defibrillators do for cardiovascular disease,” he said.
The best help, he says, will be continuation of treatment.
“Addiction is a chronic condition,” he says, “but often we only provide episodic care. We see that particularly in pregnancy. Once the pregnancy is finished, there’s not categorical continuation of insurance.”
Even if you do have insurance, it’s hard to find a clinic that’s family friendly, he notes. “You might not feel comfortable taking your newborn and standing in line in the morning to get your daily methodone dose. We have to make those environments more welcoming.”
Problem probably understated
He also says that though the study was well done given the data available, he’s frustrated that researchers still have to depend on billing data and can’t capture factors such as child care availability, living wages, and continuation of health insurance. Additionally, not everyone is coded correctly for OUD.
“It’s all Medicaid, so it’s only people who continued with care,” he pointed out. That means these numbers may actually underrepresent the problem.
Still, he says it’s important to realize the magnitude of deaths this study does highlight in this population.
In people with OUD in the postpartum period, the deaths are more than 1 in 1,000.
“That should be alarming,” Dr. Terplan said. “That’s a very big number from a public health perspective.”
Coauthor Kathryn J. Gray received payment from Aetion Inc., Roche, and BillionToOne. Funds were paid to the University of Utah for Dr. Smid from Alydia Inc. for being the site principal investigator for a study of the JADA device, and from Gilead for Dr. Smid’s study of hepatitis C in pregnancy; she was also a consultant for Organon and Rhia Ventures. Dr. Terplan reports no relevant financial relationships.
(OUD), according to research published in Obstetrics and Gynecology.
Opioid overdose deaths account for up to 10% of pregnancy-associated deaths in the United States, and 75% of the deliveries of women with OUD are covered by Medicaid, according to lead author Elizabeth Suarez, PhD, MPH, with the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
Nearly 5 million deliveries studied
Researchers studied claims data from Medicaid and the National Death Index database in the United States from 2006 to 2013 for 4,972,061 deliveries. They also identified a subgroup of women with a documented history of OUD in the 3 months before delivery.
They found the incidence of postpartum opioid overdose deaths was 5.4 per 100,000 deliveries (95% confidence interval, 4.5-6.4) among all in the study and 118 per 100,000 (95% CI, 84-163) among individuals with OUD.
Incidence of all-cause postpartum death was six times higher in women with OUD than in all the women studied. Common causes of death of those with OUD were other drug- and alcohol-related deaths (47/100,000); suicide (26/100,000); and other injuries, including accidents and falls (33/100,000).
Risk factors strongly linked with postpartum opioid overdose death included mental health and other substance use disorders.
Medication significantly lowers death risk
The authors also documented the benefit of buprenorphine or methadone for OUD.
For women with OUD who used medication to treat OUD post partum, odds of opioid overdose death were 60% lower (odds ratio, 0.4; 95% CI 0.1-0.9).
As important as use of medication, Marcela Smid, MD, MS, writes in an accompanying editorial, is noting that 80% of the women in this study who died of opioid overdoses had contact with a health care provider before death.
“Both of these results indicate that we have the means and opportunity to prevent these deaths,” writes Dr. Smid, with the division of maternal fetal medicine, University of Utah Health in Salt Lake City.
Dismal numbers on ob.gyns. trained to prescribe medications
She points out some barriers, however. Most clinicians, she notes, lack time and training to prescribe buprenorphine, and in 2019, fewer than 2% of ob.gyns. who accept Medicaid were able to prescribe it.
Her charge to ob.gyns.: “We need to help identify individuals who are at high risk of OUD or opioid overdose by screening.” A validated screening tool should be used at prenatal and postpartum appointments.
On a bigger scale, she urges Medicaid to be expanded for a full year post partum through the American Rescue Act’s State Plan Amendment, something only 28 states and Washington, D.C., have done so far.
Dr. Smid points out some good news, however: President Joe Biden signed the Consolidated Appropriations Act 2023, which eliminated the “X” waiver.
Now all clinicians who have a Drug Enforcement Administration registration that includes Schedule III authority can prescribe buprenorphine for OUD if applicable state law allows it.
But that calls for medical schools and residency programs to prioritize addiction medicine as a core competency, Dr. Smid says.
Getting naloxone to patients, families
One of the potential interventions the study authors suggest is providing naloxone prescriptions and training to pregnant and postpartum women who have a substance use history and to their partners and significant others.
However, Mishka Terplan, MD, MPH, told this publication, “It’s one thing to write a prescription; it’s another thing for the person to actually get the medication.” He is medical director of the Friends Research Institute in Baltimore, an ob.gyn. who specializes in addiction medicine.
“What can we do?” We can think about how to get naloxone into people’s hands at discharge from the hospital after they give birth, instead of prescribing. That would mean that health systems need to prioritize this, he said. “We give people discharge medications all the time.”
Still, naloxone can’t be seen as the answer, he said.
He compares it to defibrillators in public places, which are for rescues, not reversing a population problem.
“Some people think that naloxone reversals are doing something about OUD. It’s doing about as much about OUD as defibrillators do for cardiovascular disease,” he said.
The best help, he says, will be continuation of treatment.
“Addiction is a chronic condition,” he says, “but often we only provide episodic care. We see that particularly in pregnancy. Once the pregnancy is finished, there’s not categorical continuation of insurance.”
Even if you do have insurance, it’s hard to find a clinic that’s family friendly, he notes. “You might not feel comfortable taking your newborn and standing in line in the morning to get your daily methodone dose. We have to make those environments more welcoming.”
Problem probably understated
He also says that though the study was well done given the data available, he’s frustrated that researchers still have to depend on billing data and can’t capture factors such as child care availability, living wages, and continuation of health insurance. Additionally, not everyone is coded correctly for OUD.
“It’s all Medicaid, so it’s only people who continued with care,” he pointed out. That means these numbers may actually underrepresent the problem.
Still, he says it’s important to realize the magnitude of deaths this study does highlight in this population.
In people with OUD in the postpartum period, the deaths are more than 1 in 1,000.
“That should be alarming,” Dr. Terplan said. “That’s a very big number from a public health perspective.”
Coauthor Kathryn J. Gray received payment from Aetion Inc., Roche, and BillionToOne. Funds were paid to the University of Utah for Dr. Smid from Alydia Inc. for being the site principal investigator for a study of the JADA device, and from Gilead for Dr. Smid’s study of hepatitis C in pregnancy; she was also a consultant for Organon and Rhia Ventures. Dr. Terplan reports no relevant financial relationships.
(OUD), according to research published in Obstetrics and Gynecology.
Opioid overdose deaths account for up to 10% of pregnancy-associated deaths in the United States, and 75% of the deliveries of women with OUD are covered by Medicaid, according to lead author Elizabeth Suarez, PhD, MPH, with the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
Nearly 5 million deliveries studied
Researchers studied claims data from Medicaid and the National Death Index database in the United States from 2006 to 2013 for 4,972,061 deliveries. They also identified a subgroup of women with a documented history of OUD in the 3 months before delivery.
They found the incidence of postpartum opioid overdose deaths was 5.4 per 100,000 deliveries (95% confidence interval, 4.5-6.4) among all in the study and 118 per 100,000 (95% CI, 84-163) among individuals with OUD.
Incidence of all-cause postpartum death was six times higher in women with OUD than in all the women studied. Common causes of death of those with OUD were other drug- and alcohol-related deaths (47/100,000); suicide (26/100,000); and other injuries, including accidents and falls (33/100,000).
Risk factors strongly linked with postpartum opioid overdose death included mental health and other substance use disorders.
Medication significantly lowers death risk
The authors also documented the benefit of buprenorphine or methadone for OUD.
For women with OUD who used medication to treat OUD post partum, odds of opioid overdose death were 60% lower (odds ratio, 0.4; 95% CI 0.1-0.9).
As important as use of medication, Marcela Smid, MD, MS, writes in an accompanying editorial, is noting that 80% of the women in this study who died of opioid overdoses had contact with a health care provider before death.
“Both of these results indicate that we have the means and opportunity to prevent these deaths,” writes Dr. Smid, with the division of maternal fetal medicine, University of Utah Health in Salt Lake City.
Dismal numbers on ob.gyns. trained to prescribe medications
She points out some barriers, however. Most clinicians, she notes, lack time and training to prescribe buprenorphine, and in 2019, fewer than 2% of ob.gyns. who accept Medicaid were able to prescribe it.
Her charge to ob.gyns.: “We need to help identify individuals who are at high risk of OUD or opioid overdose by screening.” A validated screening tool should be used at prenatal and postpartum appointments.
On a bigger scale, she urges Medicaid to be expanded for a full year post partum through the American Rescue Act’s State Plan Amendment, something only 28 states and Washington, D.C., have done so far.
Dr. Smid points out some good news, however: President Joe Biden signed the Consolidated Appropriations Act 2023, which eliminated the “X” waiver.
Now all clinicians who have a Drug Enforcement Administration registration that includes Schedule III authority can prescribe buprenorphine for OUD if applicable state law allows it.
But that calls for medical schools and residency programs to prioritize addiction medicine as a core competency, Dr. Smid says.
Getting naloxone to patients, families
One of the potential interventions the study authors suggest is providing naloxone prescriptions and training to pregnant and postpartum women who have a substance use history and to their partners and significant others.
However, Mishka Terplan, MD, MPH, told this publication, “It’s one thing to write a prescription; it’s another thing for the person to actually get the medication.” He is medical director of the Friends Research Institute in Baltimore, an ob.gyn. who specializes in addiction medicine.
“What can we do?” We can think about how to get naloxone into people’s hands at discharge from the hospital after they give birth, instead of prescribing. That would mean that health systems need to prioritize this, he said. “We give people discharge medications all the time.”
Still, naloxone can’t be seen as the answer, he said.
He compares it to defibrillators in public places, which are for rescues, not reversing a population problem.
“Some people think that naloxone reversals are doing something about OUD. It’s doing about as much about OUD as defibrillators do for cardiovascular disease,” he said.
The best help, he says, will be continuation of treatment.
“Addiction is a chronic condition,” he says, “but often we only provide episodic care. We see that particularly in pregnancy. Once the pregnancy is finished, there’s not categorical continuation of insurance.”
Even if you do have insurance, it’s hard to find a clinic that’s family friendly, he notes. “You might not feel comfortable taking your newborn and standing in line in the morning to get your daily methodone dose. We have to make those environments more welcoming.”
Problem probably understated
He also says that though the study was well done given the data available, he’s frustrated that researchers still have to depend on billing data and can’t capture factors such as child care availability, living wages, and continuation of health insurance. Additionally, not everyone is coded correctly for OUD.
“It’s all Medicaid, so it’s only people who continued with care,” he pointed out. That means these numbers may actually underrepresent the problem.
Still, he says it’s important to realize the magnitude of deaths this study does highlight in this population.
In people with OUD in the postpartum period, the deaths are more than 1 in 1,000.
“That should be alarming,” Dr. Terplan said. “That’s a very big number from a public health perspective.”
Coauthor Kathryn J. Gray received payment from Aetion Inc., Roche, and BillionToOne. Funds were paid to the University of Utah for Dr. Smid from Alydia Inc. for being the site principal investigator for a study of the JADA device, and from Gilead for Dr. Smid’s study of hepatitis C in pregnancy; she was also a consultant for Organon and Rhia Ventures. Dr. Terplan reports no relevant financial relationships.
FROM OBSTETRICS AND GYNECOLOGY
Induced labor associated with poor school performance of offspring
On average, children born following induced labor perform worse at school at age 12 years than their peers who were born after spontaneous onset of labor. This is the outcome of a report by Anita Ravelli, PhD, and her team of Dutch researchers in the department of obstetrics and gynecology of the Amsterdam University Medical Center, published in Acta Obstetricia et Gynecologica Scandinavica.
For the retrospective cohort study, the team analyzed data from almost 230,000 patients. According to these data, the likelihood of children reaching higher secondary school level is around 10% lower after elective induction of labor.
Labor induction frequent
These days in Germany, more than 20% of all births are induced. Sometimes this decision is made because of medical reasons, such as the woman’s having gestational diabetes, the presence of gestational toxicity, or the occurrence of a premature rupture of membranes. However, contractions are most often artificially triggered because the expected delivery date has passed.
Guidelines from the German Society of Gynecology and Obstetrics recommend inducing labor if there is a medical indication and if more than 10 days have passed since the expected delivery date. After 14 days, induction is strongly advised. This recommendation is based on studies that indicate that the child is at increased risk of disease and death once the expected delivery date is far exceeded.
Causal relationship unproven
It is still unclear whether and to what extent inducing labor affects a child’s neurologic development. Since the frequency of induced labor has increased greatly worldwide, Dr. Ravelli and her colleagues investigated this matter.
The study may have limited validity, however. “The outcome of the study only determines an association between spontaneous labor in mature children versus induced labor and a school performance test at 12 years of age,” said Maria Delius, MD, MPH, head of the Perinatal Center at the Clinic and Polyclinic for Obstetrics and Gynecology of the Ludwig Maximilian University of Munich. “The study is unable to prove any causality, even if it sounds that way in the abstract.”
This publication may in no way instigate a change in current practices, Dr. Delius emphasized. “There is a lot of potential for the wrong conclusions to be drawn from this study, and as a result – if it is presented and perceived in a subjective manner in public – to also cause harm to mothers and children,” she warned. The study also must not be associated with the drug misoprostol, since the various mechanical and medicinal methods of induction were not the topic of the Dutch investigation.
Gestational-week differences
The primary author of the study, Renee J. Burger, MD, PhD, of Dr. Ravelli’s UMC team, and her colleagues assessed the school performance of 226,684 children at age 12 years who were born in the 37th to 42nd week of gestation (WOG) between 2003 and 2008 in the Netherlands following an uncomplicated single pregnancy. They compared school performance, divided for each of the six WOG analyzed, between children whose birth was mechanically or medicinally induced and those who were born without intervention.
According to the report by the researchers, induced labor at every WOG up to the 41st week was associated with lower school performance in the children, compared with a spontaneous birth. In addition, fewer children whose birth was induced reached a higher secondary level of education. After 38 WOG, the figure stood at 48%, compared with 54% of children who were born without intervention. For 12-year-olds not born until the 42nd WOG, there were no significant differences between the two groups investigated.
Prospective studies pending
Dr. Burger and Dr. Ravelli emphasized that the results do not indicate that every child born after an induced labor will perform worse at school. This is a statistical correlation that cannot be transferred to a case-by-case basis. In addition, it is unlikely that all disruptive factors could be taken into consideration during the analyses. Nonetheless, the researchers conclude that the long-term effects of inducing labor should be considered during consultation and decision-making in the future.
In general, it is important that future randomized, controlled studies incorporate long-term measurements in their results and conclusions so that complete data on the present topic can be gathered. “Although the effect on the individual child is likely subtle, the impact on society due to the large number of early-term labor inductions should not be underestimated,” the authors wrote.
Unexamined disruptive factors
Sven Kehl, MD, PhD, senior physician of the department of obstetrics and gynecology and coordinator of the University Perinatal Center of Franconia at the University Hospital of Erlangen, Germany, is of a similar opinion. “Inducing labor causes birth to occur sooner and therefore for the pregnancy to finish prematurely,” said Dr. Kehl. Such premature births, not the mechanical or medicinal procedures for inducing labor, could affect the child’s cerebral development. “The results of this study suggest that inducing labor in uncomplicated pregnancies, in which there are no relevant medical indications, should be avoided,” said Dr. Kehl. In these cases, the mother should wait for a natural birth.
Some of the study’s strengths include the large quantity of data, the large number of participants, and the various disruptive factors taken into consideration, such as the mother’s level of education, according to Dr. Kehl. “But it is not a study from which causality can be derived,” he said.
Not all the potential disruptive factors could be found in the available data. For example, information regarding familial status, the father’s level of education, the parents’ smoking status, or the mother’s body mass index was missing. Also, only a small number of the possible indications for inducing labor was disclosed.
No elective inductions
The study is unlikely to have a major effect on practice in German maternity clinics, since the routine induction of labor from the 39th WOG has always been regarded critically in German-speaking countries, said Dr. Kehl. It is still true that if there are any risks, a risk-benefit analysis must be performed, and the risks to the mother or child must be evaluated when considering labor induction.
“If there are no medical reasons for inducing labor, the women must also be informed about the possible long-term consequences and not just about the short-term risks,” said Dr. Kehl.
His colleague in Berlin, Michael Abou-Dakn, MD, chief physician of gynecology and obstetrics at the St. Joseph’s Hospital, Berlin-Tempelhof, was more categorical. “It is right to criticize the fact that over 20% of births in Germany are induced,” he said. He is rather dubious, however, about the effects on school performance found in the study following induced labor. Still, the investigation is a reminder that inducing labor could involve side effects. “There should therefore be no elective inductions, or any without a clear indication,” said Dr. Abou-Dakn.
This article was translated from the Medscape German Edition and a version appeared on Medscape.com.
On average, children born following induced labor perform worse at school at age 12 years than their peers who were born after spontaneous onset of labor. This is the outcome of a report by Anita Ravelli, PhD, and her team of Dutch researchers in the department of obstetrics and gynecology of the Amsterdam University Medical Center, published in Acta Obstetricia et Gynecologica Scandinavica.
For the retrospective cohort study, the team analyzed data from almost 230,000 patients. According to these data, the likelihood of children reaching higher secondary school level is around 10% lower after elective induction of labor.
Labor induction frequent
These days in Germany, more than 20% of all births are induced. Sometimes this decision is made because of medical reasons, such as the woman’s having gestational diabetes, the presence of gestational toxicity, or the occurrence of a premature rupture of membranes. However, contractions are most often artificially triggered because the expected delivery date has passed.
Guidelines from the German Society of Gynecology and Obstetrics recommend inducing labor if there is a medical indication and if more than 10 days have passed since the expected delivery date. After 14 days, induction is strongly advised. This recommendation is based on studies that indicate that the child is at increased risk of disease and death once the expected delivery date is far exceeded.
Causal relationship unproven
It is still unclear whether and to what extent inducing labor affects a child’s neurologic development. Since the frequency of induced labor has increased greatly worldwide, Dr. Ravelli and her colleagues investigated this matter.
The study may have limited validity, however. “The outcome of the study only determines an association between spontaneous labor in mature children versus induced labor and a school performance test at 12 years of age,” said Maria Delius, MD, MPH, head of the Perinatal Center at the Clinic and Polyclinic for Obstetrics and Gynecology of the Ludwig Maximilian University of Munich. “The study is unable to prove any causality, even if it sounds that way in the abstract.”
This publication may in no way instigate a change in current practices, Dr. Delius emphasized. “There is a lot of potential for the wrong conclusions to be drawn from this study, and as a result – if it is presented and perceived in a subjective manner in public – to also cause harm to mothers and children,” she warned. The study also must not be associated with the drug misoprostol, since the various mechanical and medicinal methods of induction were not the topic of the Dutch investigation.
Gestational-week differences
The primary author of the study, Renee J. Burger, MD, PhD, of Dr. Ravelli’s UMC team, and her colleagues assessed the school performance of 226,684 children at age 12 years who were born in the 37th to 42nd week of gestation (WOG) between 2003 and 2008 in the Netherlands following an uncomplicated single pregnancy. They compared school performance, divided for each of the six WOG analyzed, between children whose birth was mechanically or medicinally induced and those who were born without intervention.
According to the report by the researchers, induced labor at every WOG up to the 41st week was associated with lower school performance in the children, compared with a spontaneous birth. In addition, fewer children whose birth was induced reached a higher secondary level of education. After 38 WOG, the figure stood at 48%, compared with 54% of children who were born without intervention. For 12-year-olds not born until the 42nd WOG, there were no significant differences between the two groups investigated.
Prospective studies pending
Dr. Burger and Dr. Ravelli emphasized that the results do not indicate that every child born after an induced labor will perform worse at school. This is a statistical correlation that cannot be transferred to a case-by-case basis. In addition, it is unlikely that all disruptive factors could be taken into consideration during the analyses. Nonetheless, the researchers conclude that the long-term effects of inducing labor should be considered during consultation and decision-making in the future.
In general, it is important that future randomized, controlled studies incorporate long-term measurements in their results and conclusions so that complete data on the present topic can be gathered. “Although the effect on the individual child is likely subtle, the impact on society due to the large number of early-term labor inductions should not be underestimated,” the authors wrote.
Unexamined disruptive factors
Sven Kehl, MD, PhD, senior physician of the department of obstetrics and gynecology and coordinator of the University Perinatal Center of Franconia at the University Hospital of Erlangen, Germany, is of a similar opinion. “Inducing labor causes birth to occur sooner and therefore for the pregnancy to finish prematurely,” said Dr. Kehl. Such premature births, not the mechanical or medicinal procedures for inducing labor, could affect the child’s cerebral development. “The results of this study suggest that inducing labor in uncomplicated pregnancies, in which there are no relevant medical indications, should be avoided,” said Dr. Kehl. In these cases, the mother should wait for a natural birth.
Some of the study’s strengths include the large quantity of data, the large number of participants, and the various disruptive factors taken into consideration, such as the mother’s level of education, according to Dr. Kehl. “But it is not a study from which causality can be derived,” he said.
Not all the potential disruptive factors could be found in the available data. For example, information regarding familial status, the father’s level of education, the parents’ smoking status, or the mother’s body mass index was missing. Also, only a small number of the possible indications for inducing labor was disclosed.
No elective inductions
The study is unlikely to have a major effect on practice in German maternity clinics, since the routine induction of labor from the 39th WOG has always been regarded critically in German-speaking countries, said Dr. Kehl. It is still true that if there are any risks, a risk-benefit analysis must be performed, and the risks to the mother or child must be evaluated when considering labor induction.
“If there are no medical reasons for inducing labor, the women must also be informed about the possible long-term consequences and not just about the short-term risks,” said Dr. Kehl.
His colleague in Berlin, Michael Abou-Dakn, MD, chief physician of gynecology and obstetrics at the St. Joseph’s Hospital, Berlin-Tempelhof, was more categorical. “It is right to criticize the fact that over 20% of births in Germany are induced,” he said. He is rather dubious, however, about the effects on school performance found in the study following induced labor. Still, the investigation is a reminder that inducing labor could involve side effects. “There should therefore be no elective inductions, or any without a clear indication,” said Dr. Abou-Dakn.
This article was translated from the Medscape German Edition and a version appeared on Medscape.com.
On average, children born following induced labor perform worse at school at age 12 years than their peers who were born after spontaneous onset of labor. This is the outcome of a report by Anita Ravelli, PhD, and her team of Dutch researchers in the department of obstetrics and gynecology of the Amsterdam University Medical Center, published in Acta Obstetricia et Gynecologica Scandinavica.
For the retrospective cohort study, the team analyzed data from almost 230,000 patients. According to these data, the likelihood of children reaching higher secondary school level is around 10% lower after elective induction of labor.
Labor induction frequent
These days in Germany, more than 20% of all births are induced. Sometimes this decision is made because of medical reasons, such as the woman’s having gestational diabetes, the presence of gestational toxicity, or the occurrence of a premature rupture of membranes. However, contractions are most often artificially triggered because the expected delivery date has passed.
Guidelines from the German Society of Gynecology and Obstetrics recommend inducing labor if there is a medical indication and if more than 10 days have passed since the expected delivery date. After 14 days, induction is strongly advised. This recommendation is based on studies that indicate that the child is at increased risk of disease and death once the expected delivery date is far exceeded.
Causal relationship unproven
It is still unclear whether and to what extent inducing labor affects a child’s neurologic development. Since the frequency of induced labor has increased greatly worldwide, Dr. Ravelli and her colleagues investigated this matter.
The study may have limited validity, however. “The outcome of the study only determines an association between spontaneous labor in mature children versus induced labor and a school performance test at 12 years of age,” said Maria Delius, MD, MPH, head of the Perinatal Center at the Clinic and Polyclinic for Obstetrics and Gynecology of the Ludwig Maximilian University of Munich. “The study is unable to prove any causality, even if it sounds that way in the abstract.”
This publication may in no way instigate a change in current practices, Dr. Delius emphasized. “There is a lot of potential for the wrong conclusions to be drawn from this study, and as a result – if it is presented and perceived in a subjective manner in public – to also cause harm to mothers and children,” she warned. The study also must not be associated with the drug misoprostol, since the various mechanical and medicinal methods of induction were not the topic of the Dutch investigation.
Gestational-week differences
The primary author of the study, Renee J. Burger, MD, PhD, of Dr. Ravelli’s UMC team, and her colleagues assessed the school performance of 226,684 children at age 12 years who were born in the 37th to 42nd week of gestation (WOG) between 2003 and 2008 in the Netherlands following an uncomplicated single pregnancy. They compared school performance, divided for each of the six WOG analyzed, between children whose birth was mechanically or medicinally induced and those who were born without intervention.
According to the report by the researchers, induced labor at every WOG up to the 41st week was associated with lower school performance in the children, compared with a spontaneous birth. In addition, fewer children whose birth was induced reached a higher secondary level of education. After 38 WOG, the figure stood at 48%, compared with 54% of children who were born without intervention. For 12-year-olds not born until the 42nd WOG, there were no significant differences between the two groups investigated.
Prospective studies pending
Dr. Burger and Dr. Ravelli emphasized that the results do not indicate that every child born after an induced labor will perform worse at school. This is a statistical correlation that cannot be transferred to a case-by-case basis. In addition, it is unlikely that all disruptive factors could be taken into consideration during the analyses. Nonetheless, the researchers conclude that the long-term effects of inducing labor should be considered during consultation and decision-making in the future.
In general, it is important that future randomized, controlled studies incorporate long-term measurements in their results and conclusions so that complete data on the present topic can be gathered. “Although the effect on the individual child is likely subtle, the impact on society due to the large number of early-term labor inductions should not be underestimated,” the authors wrote.
Unexamined disruptive factors
Sven Kehl, MD, PhD, senior physician of the department of obstetrics and gynecology and coordinator of the University Perinatal Center of Franconia at the University Hospital of Erlangen, Germany, is of a similar opinion. “Inducing labor causes birth to occur sooner and therefore for the pregnancy to finish prematurely,” said Dr. Kehl. Such premature births, not the mechanical or medicinal procedures for inducing labor, could affect the child’s cerebral development. “The results of this study suggest that inducing labor in uncomplicated pregnancies, in which there are no relevant medical indications, should be avoided,” said Dr. Kehl. In these cases, the mother should wait for a natural birth.
Some of the study’s strengths include the large quantity of data, the large number of participants, and the various disruptive factors taken into consideration, such as the mother’s level of education, according to Dr. Kehl. “But it is not a study from which causality can be derived,” he said.
Not all the potential disruptive factors could be found in the available data. For example, information regarding familial status, the father’s level of education, the parents’ smoking status, or the mother’s body mass index was missing. Also, only a small number of the possible indications for inducing labor was disclosed.
No elective inductions
The study is unlikely to have a major effect on practice in German maternity clinics, since the routine induction of labor from the 39th WOG has always been regarded critically in German-speaking countries, said Dr. Kehl. It is still true that if there are any risks, a risk-benefit analysis must be performed, and the risks to the mother or child must be evaluated when considering labor induction.
“If there are no medical reasons for inducing labor, the women must also be informed about the possible long-term consequences and not just about the short-term risks,” said Dr. Kehl.
His colleague in Berlin, Michael Abou-Dakn, MD, chief physician of gynecology and obstetrics at the St. Joseph’s Hospital, Berlin-Tempelhof, was more categorical. “It is right to criticize the fact that over 20% of births in Germany are induced,” he said. He is rather dubious, however, about the effects on school performance found in the study following induced labor. Still, the investigation is a reminder that inducing labor could involve side effects. “There should therefore be no elective inductions, or any without a clear indication,” said Dr. Abou-Dakn.
This article was translated from the Medscape German Edition and a version appeared on Medscape.com.
FDA strengthens mammography regulations: Final rule
A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.
The rule requires implementation of the changes within 18 months.
According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.
For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”
A version of this article first appeared on Medscape.com.
A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.
The rule requires implementation of the changes within 18 months.
According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.
For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”
A version of this article first appeared on Medscape.com.
A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.
The rule requires implementation of the changes within 18 months.
According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.
For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”
A version of this article first appeared on Medscape.com.
In utero exposure to asthma medication not tied to risks of neurodevelopmental disorders
The drugs included in the study were leukotriene-receptor antagonists (LTRAs), which are often used to treat allergic airway diseases, including asthma and allergic rhinitis.
“Over the years, the U.S. Food and Drug Administration has monitored post-marketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious mental health side effects for montelukast in 2020,” said corresponding author Tsung-Chieh Yao, MD, of Chang Gung Memorial Hospital, Taiwan, in an interview.
However, evidence of a link between NEs and LTRA use has been inconsistent, according to Dr. Yao and colleagues.
“To date, it remains totally unknown whether the exposure to LTRAs during pregnancy is associated with the risk of neuropsychiatric events in offspring,” said Dr. Yao.
To address this question, the researchers used data from National Health Insurance Research Database in Taiwan to identify pregnant women and their offspring from 2009 to 2019. The initial study population included 576,157 mother-offspring pairs, including 1,995 LTRA-exposed and 574,162 nonexposed children.
The women had a diagnosis of asthma or allergic rhinitis; multiple births and children with congenital malformations were excluded. LTRA exposure was defined as any dispensed prescription for LTRAs during pregnancy. Approximately two-thirds of the mothers were aged 30-40 years at the time of delivery.
The findings were published in a research letter in JAMA Network Open.
In the study population at large, the incidence of the three neurodevelopmental disorders ADHD, autism spectrum disorder (ASD), and Tourette syndrome was not significantly different between those children exposed to LTRAs and those not exposed to LTRAs in utero (1.25% vs. 1.32%; 3.31% vs. 4.36%; and 0.45% vs. 0.83%, respectively).
After propensity score matching, the study population included 1,988 LTRA-exposed children and 19,863 nonexposed children. In this group, no significant associations appeared between prenatal LTRA exposure and the risk of attention-deficit/hyperactivity disorder (adjusted hazard ratio, 1.03), autism spectrum disorder (AHR, 1.01), and Tourette syndrome (AHR, 0.63).
Neither duration nor cumulative dose of LTRA use during pregnancy showed an association with ADHD, ASD, or Tourette syndrome in offspring. Duration of LTRA use was categorized as shorter or longer periods of 1-4 weeks vs. more than 4 weeks; cumulative dose was categorized as 1-170 mg vs. 170 mg or higher.
The findings were limited by the lack of randomization, inability to detect long-term risk, and potential lack of generalizability to non-Asian populations, and more research is needed to replicate the results, the researchers noted. However, the current findings were strengthened by the large study population, and suggest that LTRA use in pregnancy does not present a significant risk for NEs in children, which should be reassuring to clinicians and patients, they concluded.
The current study is the first to use the whole of Taiwan population data and extends previous studies by examining the association between LTRA use during pregnancy and risk of neuropsychiatric events in offspring, Dr. Yao said in an interview. “The possibly surprising, but reassuring, finding is that prenatal LTRA exposure did not increase risk of ADHD, ASD, and Tourette syndrome in offspring,” he said.
“Clinicians prescribing LTRAs such as montelukast (Singulair and generics) to pregnant women with asthma or allergic rhinitis may be reassured by our findings,” Dr. Yao added. The results offer real-world evidence to help inform decision-making about the use of LTRAs during pregnancy, although additional research is needed to replicate the study findings in other populations, he said.
The study was supported by the National Health Research Institutes, Taiwan, the Ministry of Science and Technology of Taiwan, the National Science and Technology Council of Taiwan, and the Chang Gung Medical Foundation. The researchers had no financial conflicts to disclose.
The drugs included in the study were leukotriene-receptor antagonists (LTRAs), which are often used to treat allergic airway diseases, including asthma and allergic rhinitis.
“Over the years, the U.S. Food and Drug Administration has monitored post-marketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious mental health side effects for montelukast in 2020,” said corresponding author Tsung-Chieh Yao, MD, of Chang Gung Memorial Hospital, Taiwan, in an interview.
However, evidence of a link between NEs and LTRA use has been inconsistent, according to Dr. Yao and colleagues.
“To date, it remains totally unknown whether the exposure to LTRAs during pregnancy is associated with the risk of neuropsychiatric events in offspring,” said Dr. Yao.
To address this question, the researchers used data from National Health Insurance Research Database in Taiwan to identify pregnant women and their offspring from 2009 to 2019. The initial study population included 576,157 mother-offspring pairs, including 1,995 LTRA-exposed and 574,162 nonexposed children.
The women had a diagnosis of asthma or allergic rhinitis; multiple births and children with congenital malformations were excluded. LTRA exposure was defined as any dispensed prescription for LTRAs during pregnancy. Approximately two-thirds of the mothers were aged 30-40 years at the time of delivery.
The findings were published in a research letter in JAMA Network Open.
In the study population at large, the incidence of the three neurodevelopmental disorders ADHD, autism spectrum disorder (ASD), and Tourette syndrome was not significantly different between those children exposed to LTRAs and those not exposed to LTRAs in utero (1.25% vs. 1.32%; 3.31% vs. 4.36%; and 0.45% vs. 0.83%, respectively).
After propensity score matching, the study population included 1,988 LTRA-exposed children and 19,863 nonexposed children. In this group, no significant associations appeared between prenatal LTRA exposure and the risk of attention-deficit/hyperactivity disorder (adjusted hazard ratio, 1.03), autism spectrum disorder (AHR, 1.01), and Tourette syndrome (AHR, 0.63).
Neither duration nor cumulative dose of LTRA use during pregnancy showed an association with ADHD, ASD, or Tourette syndrome in offspring. Duration of LTRA use was categorized as shorter or longer periods of 1-4 weeks vs. more than 4 weeks; cumulative dose was categorized as 1-170 mg vs. 170 mg or higher.
The findings were limited by the lack of randomization, inability to detect long-term risk, and potential lack of generalizability to non-Asian populations, and more research is needed to replicate the results, the researchers noted. However, the current findings were strengthened by the large study population, and suggest that LTRA use in pregnancy does not present a significant risk for NEs in children, which should be reassuring to clinicians and patients, they concluded.
The current study is the first to use the whole of Taiwan population data and extends previous studies by examining the association between LTRA use during pregnancy and risk of neuropsychiatric events in offspring, Dr. Yao said in an interview. “The possibly surprising, but reassuring, finding is that prenatal LTRA exposure did not increase risk of ADHD, ASD, and Tourette syndrome in offspring,” he said.
“Clinicians prescribing LTRAs such as montelukast (Singulair and generics) to pregnant women with asthma or allergic rhinitis may be reassured by our findings,” Dr. Yao added. The results offer real-world evidence to help inform decision-making about the use of LTRAs during pregnancy, although additional research is needed to replicate the study findings in other populations, he said.
The study was supported by the National Health Research Institutes, Taiwan, the Ministry of Science and Technology of Taiwan, the National Science and Technology Council of Taiwan, and the Chang Gung Medical Foundation. The researchers had no financial conflicts to disclose.
The drugs included in the study were leukotriene-receptor antagonists (LTRAs), which are often used to treat allergic airway diseases, including asthma and allergic rhinitis.
“Over the years, the U.S. Food and Drug Administration has monitored post-marketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast, the first type of LTRAs, and issued boxed warnings about serious mental health side effects for montelukast in 2020,” said corresponding author Tsung-Chieh Yao, MD, of Chang Gung Memorial Hospital, Taiwan, in an interview.
However, evidence of a link between NEs and LTRA use has been inconsistent, according to Dr. Yao and colleagues.
“To date, it remains totally unknown whether the exposure to LTRAs during pregnancy is associated with the risk of neuropsychiatric events in offspring,” said Dr. Yao.
To address this question, the researchers used data from National Health Insurance Research Database in Taiwan to identify pregnant women and their offspring from 2009 to 2019. The initial study population included 576,157 mother-offspring pairs, including 1,995 LTRA-exposed and 574,162 nonexposed children.
The women had a diagnosis of asthma or allergic rhinitis; multiple births and children with congenital malformations were excluded. LTRA exposure was defined as any dispensed prescription for LTRAs during pregnancy. Approximately two-thirds of the mothers were aged 30-40 years at the time of delivery.
The findings were published in a research letter in JAMA Network Open.
In the study population at large, the incidence of the three neurodevelopmental disorders ADHD, autism spectrum disorder (ASD), and Tourette syndrome was not significantly different between those children exposed to LTRAs and those not exposed to LTRAs in utero (1.25% vs. 1.32%; 3.31% vs. 4.36%; and 0.45% vs. 0.83%, respectively).
After propensity score matching, the study population included 1,988 LTRA-exposed children and 19,863 nonexposed children. In this group, no significant associations appeared between prenatal LTRA exposure and the risk of attention-deficit/hyperactivity disorder (adjusted hazard ratio, 1.03), autism spectrum disorder (AHR, 1.01), and Tourette syndrome (AHR, 0.63).
Neither duration nor cumulative dose of LTRA use during pregnancy showed an association with ADHD, ASD, or Tourette syndrome in offspring. Duration of LTRA use was categorized as shorter or longer periods of 1-4 weeks vs. more than 4 weeks; cumulative dose was categorized as 1-170 mg vs. 170 mg or higher.
The findings were limited by the lack of randomization, inability to detect long-term risk, and potential lack of generalizability to non-Asian populations, and more research is needed to replicate the results, the researchers noted. However, the current findings were strengthened by the large study population, and suggest that LTRA use in pregnancy does not present a significant risk for NEs in children, which should be reassuring to clinicians and patients, they concluded.
The current study is the first to use the whole of Taiwan population data and extends previous studies by examining the association between LTRA use during pregnancy and risk of neuropsychiatric events in offspring, Dr. Yao said in an interview. “The possibly surprising, but reassuring, finding is that prenatal LTRA exposure did not increase risk of ADHD, ASD, and Tourette syndrome in offspring,” he said.
“Clinicians prescribing LTRAs such as montelukast (Singulair and generics) to pregnant women with asthma or allergic rhinitis may be reassured by our findings,” Dr. Yao added. The results offer real-world evidence to help inform decision-making about the use of LTRAs during pregnancy, although additional research is needed to replicate the study findings in other populations, he said.
The study was supported by the National Health Research Institutes, Taiwan, the Ministry of Science and Technology of Taiwan, the National Science and Technology Council of Taiwan, and the Chang Gung Medical Foundation. The researchers had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Is self-administered DMPA an answer to contraception access in the post-Roe era?
ILLUSTRATIVE CASE
A 32-year-old woman with a history of migraine with aura presents to your office for contraception management. She works full-time, has 2 children, and has transportation barriers. She previously used injectable DMPA (administered every 3 months at a health care facility) and would like to restart it. However, because she had to reschedule her last appointment due to a lack of transportation, she missed her injection window and subsequently became pregnant with her second child. She would still prefer injectable DMPA over the other contraceptive options offered—etonogestrel implant, oral contraceptive, or intrauterine device (IUD)—given her migraine history. However, she’s concerned she may have difficulty coming to the office every 3 months for her injection. What alternative injectable option can you offer?
When not pregnant or seeking to become pregnant, women may spend a significant amount of their lives trying to avoid pregnancy, and almost all women use contraception at some point.2 During the childbearing years of 15 to 49, 65% of women report using contraception.2 Although DMPA is a safe and effective option, only 2% of women report using it for contraception.2
For patients who have migraine with aura, there are fewer contraception options because their risk for ischemic stroke is increased 2- to 4-fold if they use combined hormonal contraceptives in pill, patch, or vaginal ring form.3 Safe options for these patients include the copper IUD, levonorgestrel-releasing intrauterine system, progestin implant, and DMPA injection.3
DMPA is a progestogen-only contraceptive approved by the US Food and Drug Administration to prevent pregnancy. It is available in an intramuscular formulation (DMPA-IM; 150 mg/mL every 13 weeks) and a subcutaneous formulation (DMPA-SC; 104 mg/0.65 mL every 12-14 weeks). DMPA-IM is administered by a health care provider and thus requires patients to present every 3 months for an injection. About 6% of DMPA-IM users have an unintended pregnancy in the first year due to inconsistent or incorrect use or late receipt of injection.4 DMPA-SC is produced as a prefilled needle that can be self-injected by patients.
Barriers to access are a growing concern. During the COVID-19 pandemic, one-third of women surveyed by the Guttmacher Institute (n = 2009) reported delaying or canceling a health care visit or having difficulty obtaining their contraception. Barriers to health care and contraception access were more common among Black and Hispanic women (vs White women), queer women (vs straight women), and low-income women (vs higher-income women).5
Following the overturning of Roe v Wade in June 2022, abortion access is now limited in parts of the United States. Given this significant policy change, physicians have an increasingly important role in providing contraception care and reducing barriers to contraception access. Since the SC forms of injectable contraception can be administered at home rather than in the health care setting, both the World Health Organization and the Centers for Disease Control and Prevention have recommended that self-administered injectable contraception be made widely available to expand access to contraception.6,7
STUDY SUMMARY
Higher contraceptive continuation rates with comparable safety and efficacy
This 2019 systematic review and meta-analysis evaluated the outcomes associated with use of self-administered DMPA-SC vs provider-administered DMPA in 5 countries.1 The authors searched several electronic databases for peer-reviewed studies of women who chose the option to self-administer DMPA-SC vs those who received DMPA injections from a health care provider.
Continue to: Outcomes included pregnancy
Outcomes included pregnancy; adverse effects or events (bleeding, injection site reactions, mental health concerns); initial use of injectable contraception (contraception uptake); and continuation rate of injectable contraception. Two reviewers extracted the data and assessed trials for bias. The authors used random-effects models to calculate pooled relative risk (RR) for studies with the same outcomes.
The analysis included a total of 6 trials (N = 3851): 3 RCTs (n = 1263) and 3 controlled cohort studies (n = 2588), conducted in the United States (2 trials), Malawi, Scotland, Uganda, and Senegal. All studies compared 12-month continuation rates of self-injected DMPA-SC vs provider-administered DMPA-SC or DMPA-IM every 3 months (12-13 weeks, with a window for early and late injections). Participants were at least 15 years of age (mean range, 26 to 29 years). In some studies, reminders (eg, texts, emails, calendar notifications) were provided to either the self-injection cohort only or to both cohorts of the trial. The RCTs were generally graded as having a low risk for bias, except for nonblinding of participants and personnel, given the nature of the interventions. The authors reported no evidence of significant heterogeneity in the studies.
The meta-analysis found higher continuation rates at 12 months with self-administrated DMPA compared with provider administration in the RCTs (RR = 1.27; 95% CI, 1.16-1.39) and in the observational cohort studies (RR = 1.18; 95% CI, 1.10-1.26). Pregnancy outcomes were reported in 4 studies, with the meta-analysis finding no significant difference in pregnancy rates in 2 RCTs (RR = 0.58; 95% CI, 0.15-2.22) or 2 observational cohort studies (RR = 1.1; 95% CI, 0.23-5.26).
Adverse effects or events were reported in 4 studies: 2 cohort studies reported increased injection site reactions with self-administration, and 1 RCT reported increased injection site pain or irritation with self-administration at 3 and 9 months. No other reported adverse effects occurred at higher rates with self-administration vs provider administration.
WHAT’S NEW
Demonstrated effectiveness of self-administered formulation
This systematic review and meta-analysis demonstrated that self-administration of DMPA-SC leads to higher contraception continuation rates at 12 months, without notable increased pregnancy rates or adverse effects, when compared with provider-administered DMPA.
Continue to: CAVEATS
CAVEATS
Outcome data limited to 12 months
Although self-administered DMPA-SC has the theoretical risk for user error and incorrect administration, this study did not find increased rates of pregnancy despite administration outside a health care center. However, the total number of pregnancies in each of the 4 studies measuring this outcome was low (< 5), and thus the authors noted that the effect size estimates may not be accurate.
Currently, there are no data on long-term outcomes beyond 12 months. Additionally, the health care visits for provider-administered DMPA every 3 months may afford other benefits, such as regular discussion of reproductive health concerns or testing for sexually transmitted infections, which must be weighed against the benefit of increased contraception access with self-administration. However, using the DMPA-SC self-administered formulation at home would not inhibit women from making separate health care visits as needed.
CHALLENGES TO IMPLEMENTATION
Limited resources to teach patients how to self-inject
Barriers to implementation include limited experience with prescribing DMPA-SC and changing practice culture to offer it to patients. Additionally, successful implementation of self-administered DMPA-SC is reliant on providing patients with appropriate information and training on self-injection, which requires knowledge, time, and other resources that may be limited in practices. Another potential barrier is product access, as not all insurers cover DMPA-SC and some pharmacies do not carry it.
1. Kennedy CE, Yeh PT, Gaffield ML, et al. Self-administration of injectable contraception: a systematic review and meta-analysis. BMJ Glob Health. 2019;4:e001350. doi: 10.1136/bmjgh-2018-001350
2. Daniels K, Abma J. Current contraceptive status among women aged 15-49: United States, 2017-2019. NCHS Data Brief. 2020;(388):1-8.
3. Paradise SL, Landis CA, Klein DA. Evidence-based contraception: common questions and answers. Am Fam Physician. 2022;106:251-259.
4. Marx M. Evidence‐based guidance for self‐administration of injectable contraception. J Midwifery Womens Health. 2021;66:108-112. doi: 10.1111/jmwh.13190
5. Lindberg LD, VandeVusse A, Mueller J, et al. Early Impacts of the COVID-19 Pandemic: Findings from the 2020 Guttmacher Survey of Reproductive Health Experiences. Guttmacher Institute; 2020. Accessed October 25, 2022. www.guttmacher.org/report/early-impacts-covid-19-pandemic-findings-2020-guttmacher-survey-reproductive-health
6. World Health Organization. WHO consolidated guidance on self-care interventions for health: sexual and reproductive health and rights. Published 2019. Accessed February 14, 2023. https://apps.who.int/iris/bitstream/handle/10665/325480/9789241550550-eng.pdf
7. Curtis KM, Nguyen A, Reeves JA, et al. Update to US selected practice recommendations for contraceptive use: self-administration of subcutaneous depot medroxyprogesterone acetate. MMWR Morb Mortal Wkly Rep. 2021;70:739-743. doi: 10.15585/mmwr.mm7020a2
ILLUSTRATIVE CASE
A 32-year-old woman with a history of migraine with aura presents to your office for contraception management. She works full-time, has 2 children, and has transportation barriers. She previously used injectable DMPA (administered every 3 months at a health care facility) and would like to restart it. However, because she had to reschedule her last appointment due to a lack of transportation, she missed her injection window and subsequently became pregnant with her second child. She would still prefer injectable DMPA over the other contraceptive options offered—etonogestrel implant, oral contraceptive, or intrauterine device (IUD)—given her migraine history. However, she’s concerned she may have difficulty coming to the office every 3 months for her injection. What alternative injectable option can you offer?
When not pregnant or seeking to become pregnant, women may spend a significant amount of their lives trying to avoid pregnancy, and almost all women use contraception at some point.2 During the childbearing years of 15 to 49, 65% of women report using contraception.2 Although DMPA is a safe and effective option, only 2% of women report using it for contraception.2
For patients who have migraine with aura, there are fewer contraception options because their risk for ischemic stroke is increased 2- to 4-fold if they use combined hormonal contraceptives in pill, patch, or vaginal ring form.3 Safe options for these patients include the copper IUD, levonorgestrel-releasing intrauterine system, progestin implant, and DMPA injection.3
DMPA is a progestogen-only contraceptive approved by the US Food and Drug Administration to prevent pregnancy. It is available in an intramuscular formulation (DMPA-IM; 150 mg/mL every 13 weeks) and a subcutaneous formulation (DMPA-SC; 104 mg/0.65 mL every 12-14 weeks). DMPA-IM is administered by a health care provider and thus requires patients to present every 3 months for an injection. About 6% of DMPA-IM users have an unintended pregnancy in the first year due to inconsistent or incorrect use or late receipt of injection.4 DMPA-SC is produced as a prefilled needle that can be self-injected by patients.
Barriers to access are a growing concern. During the COVID-19 pandemic, one-third of women surveyed by the Guttmacher Institute (n = 2009) reported delaying or canceling a health care visit or having difficulty obtaining their contraception. Barriers to health care and contraception access were more common among Black and Hispanic women (vs White women), queer women (vs straight women), and low-income women (vs higher-income women).5
Following the overturning of Roe v Wade in June 2022, abortion access is now limited in parts of the United States. Given this significant policy change, physicians have an increasingly important role in providing contraception care and reducing barriers to contraception access. Since the SC forms of injectable contraception can be administered at home rather than in the health care setting, both the World Health Organization and the Centers for Disease Control and Prevention have recommended that self-administered injectable contraception be made widely available to expand access to contraception.6,7
STUDY SUMMARY
Higher contraceptive continuation rates with comparable safety and efficacy
This 2019 systematic review and meta-analysis evaluated the outcomes associated with use of self-administered DMPA-SC vs provider-administered DMPA in 5 countries.1 The authors searched several electronic databases for peer-reviewed studies of women who chose the option to self-administer DMPA-SC vs those who received DMPA injections from a health care provider.
Continue to: Outcomes included pregnancy
Outcomes included pregnancy; adverse effects or events (bleeding, injection site reactions, mental health concerns); initial use of injectable contraception (contraception uptake); and continuation rate of injectable contraception. Two reviewers extracted the data and assessed trials for bias. The authors used random-effects models to calculate pooled relative risk (RR) for studies with the same outcomes.
The analysis included a total of 6 trials (N = 3851): 3 RCTs (n = 1263) and 3 controlled cohort studies (n = 2588), conducted in the United States (2 trials), Malawi, Scotland, Uganda, and Senegal. All studies compared 12-month continuation rates of self-injected DMPA-SC vs provider-administered DMPA-SC or DMPA-IM every 3 months (12-13 weeks, with a window for early and late injections). Participants were at least 15 years of age (mean range, 26 to 29 years). In some studies, reminders (eg, texts, emails, calendar notifications) were provided to either the self-injection cohort only or to both cohorts of the trial. The RCTs were generally graded as having a low risk for bias, except for nonblinding of participants and personnel, given the nature of the interventions. The authors reported no evidence of significant heterogeneity in the studies.
The meta-analysis found higher continuation rates at 12 months with self-administrated DMPA compared with provider administration in the RCTs (RR = 1.27; 95% CI, 1.16-1.39) and in the observational cohort studies (RR = 1.18; 95% CI, 1.10-1.26). Pregnancy outcomes were reported in 4 studies, with the meta-analysis finding no significant difference in pregnancy rates in 2 RCTs (RR = 0.58; 95% CI, 0.15-2.22) or 2 observational cohort studies (RR = 1.1; 95% CI, 0.23-5.26).
Adverse effects or events were reported in 4 studies: 2 cohort studies reported increased injection site reactions with self-administration, and 1 RCT reported increased injection site pain or irritation with self-administration at 3 and 9 months. No other reported adverse effects occurred at higher rates with self-administration vs provider administration.
WHAT’S NEW
Demonstrated effectiveness of self-administered formulation
This systematic review and meta-analysis demonstrated that self-administration of DMPA-SC leads to higher contraception continuation rates at 12 months, without notable increased pregnancy rates or adverse effects, when compared with provider-administered DMPA.
Continue to: CAVEATS
CAVEATS
Outcome data limited to 12 months
Although self-administered DMPA-SC has the theoretical risk for user error and incorrect administration, this study did not find increased rates of pregnancy despite administration outside a health care center. However, the total number of pregnancies in each of the 4 studies measuring this outcome was low (< 5), and thus the authors noted that the effect size estimates may not be accurate.
Currently, there are no data on long-term outcomes beyond 12 months. Additionally, the health care visits for provider-administered DMPA every 3 months may afford other benefits, such as regular discussion of reproductive health concerns or testing for sexually transmitted infections, which must be weighed against the benefit of increased contraception access with self-administration. However, using the DMPA-SC self-administered formulation at home would not inhibit women from making separate health care visits as needed.
CHALLENGES TO IMPLEMENTATION
Limited resources to teach patients how to self-inject
Barriers to implementation include limited experience with prescribing DMPA-SC and changing practice culture to offer it to patients. Additionally, successful implementation of self-administered DMPA-SC is reliant on providing patients with appropriate information and training on self-injection, which requires knowledge, time, and other resources that may be limited in practices. Another potential barrier is product access, as not all insurers cover DMPA-SC and some pharmacies do not carry it.
ILLUSTRATIVE CASE
A 32-year-old woman with a history of migraine with aura presents to your office for contraception management. She works full-time, has 2 children, and has transportation barriers. She previously used injectable DMPA (administered every 3 months at a health care facility) and would like to restart it. However, because she had to reschedule her last appointment due to a lack of transportation, she missed her injection window and subsequently became pregnant with her second child. She would still prefer injectable DMPA over the other contraceptive options offered—etonogestrel implant, oral contraceptive, or intrauterine device (IUD)—given her migraine history. However, she’s concerned she may have difficulty coming to the office every 3 months for her injection. What alternative injectable option can you offer?
When not pregnant or seeking to become pregnant, women may spend a significant amount of their lives trying to avoid pregnancy, and almost all women use contraception at some point.2 During the childbearing years of 15 to 49, 65% of women report using contraception.2 Although DMPA is a safe and effective option, only 2% of women report using it for contraception.2
For patients who have migraine with aura, there are fewer contraception options because their risk for ischemic stroke is increased 2- to 4-fold if they use combined hormonal contraceptives in pill, patch, or vaginal ring form.3 Safe options for these patients include the copper IUD, levonorgestrel-releasing intrauterine system, progestin implant, and DMPA injection.3
DMPA is a progestogen-only contraceptive approved by the US Food and Drug Administration to prevent pregnancy. It is available in an intramuscular formulation (DMPA-IM; 150 mg/mL every 13 weeks) and a subcutaneous formulation (DMPA-SC; 104 mg/0.65 mL every 12-14 weeks). DMPA-IM is administered by a health care provider and thus requires patients to present every 3 months for an injection. About 6% of DMPA-IM users have an unintended pregnancy in the first year due to inconsistent or incorrect use or late receipt of injection.4 DMPA-SC is produced as a prefilled needle that can be self-injected by patients.
Barriers to access are a growing concern. During the COVID-19 pandemic, one-third of women surveyed by the Guttmacher Institute (n = 2009) reported delaying or canceling a health care visit or having difficulty obtaining their contraception. Barriers to health care and contraception access were more common among Black and Hispanic women (vs White women), queer women (vs straight women), and low-income women (vs higher-income women).5
Following the overturning of Roe v Wade in June 2022, abortion access is now limited in parts of the United States. Given this significant policy change, physicians have an increasingly important role in providing contraception care and reducing barriers to contraception access. Since the SC forms of injectable contraception can be administered at home rather than in the health care setting, both the World Health Organization and the Centers for Disease Control and Prevention have recommended that self-administered injectable contraception be made widely available to expand access to contraception.6,7
STUDY SUMMARY
Higher contraceptive continuation rates with comparable safety and efficacy
This 2019 systematic review and meta-analysis evaluated the outcomes associated with use of self-administered DMPA-SC vs provider-administered DMPA in 5 countries.1 The authors searched several electronic databases for peer-reviewed studies of women who chose the option to self-administer DMPA-SC vs those who received DMPA injections from a health care provider.
Continue to: Outcomes included pregnancy
Outcomes included pregnancy; adverse effects or events (bleeding, injection site reactions, mental health concerns); initial use of injectable contraception (contraception uptake); and continuation rate of injectable contraception. Two reviewers extracted the data and assessed trials for bias. The authors used random-effects models to calculate pooled relative risk (RR) for studies with the same outcomes.
The analysis included a total of 6 trials (N = 3851): 3 RCTs (n = 1263) and 3 controlled cohort studies (n = 2588), conducted in the United States (2 trials), Malawi, Scotland, Uganda, and Senegal. All studies compared 12-month continuation rates of self-injected DMPA-SC vs provider-administered DMPA-SC or DMPA-IM every 3 months (12-13 weeks, with a window for early and late injections). Participants were at least 15 years of age (mean range, 26 to 29 years). In some studies, reminders (eg, texts, emails, calendar notifications) were provided to either the self-injection cohort only or to both cohorts of the trial. The RCTs were generally graded as having a low risk for bias, except for nonblinding of participants and personnel, given the nature of the interventions. The authors reported no evidence of significant heterogeneity in the studies.
The meta-analysis found higher continuation rates at 12 months with self-administrated DMPA compared with provider administration in the RCTs (RR = 1.27; 95% CI, 1.16-1.39) and in the observational cohort studies (RR = 1.18; 95% CI, 1.10-1.26). Pregnancy outcomes were reported in 4 studies, with the meta-analysis finding no significant difference in pregnancy rates in 2 RCTs (RR = 0.58; 95% CI, 0.15-2.22) or 2 observational cohort studies (RR = 1.1; 95% CI, 0.23-5.26).
Adverse effects or events were reported in 4 studies: 2 cohort studies reported increased injection site reactions with self-administration, and 1 RCT reported increased injection site pain or irritation with self-administration at 3 and 9 months. No other reported adverse effects occurred at higher rates with self-administration vs provider administration.
WHAT’S NEW
Demonstrated effectiveness of self-administered formulation
This systematic review and meta-analysis demonstrated that self-administration of DMPA-SC leads to higher contraception continuation rates at 12 months, without notable increased pregnancy rates or adverse effects, when compared with provider-administered DMPA.
Continue to: CAVEATS
CAVEATS
Outcome data limited to 12 months
Although self-administered DMPA-SC has the theoretical risk for user error and incorrect administration, this study did not find increased rates of pregnancy despite administration outside a health care center. However, the total number of pregnancies in each of the 4 studies measuring this outcome was low (< 5), and thus the authors noted that the effect size estimates may not be accurate.
Currently, there are no data on long-term outcomes beyond 12 months. Additionally, the health care visits for provider-administered DMPA every 3 months may afford other benefits, such as regular discussion of reproductive health concerns or testing for sexually transmitted infections, which must be weighed against the benefit of increased contraception access with self-administration. However, using the DMPA-SC self-administered formulation at home would not inhibit women from making separate health care visits as needed.
CHALLENGES TO IMPLEMENTATION
Limited resources to teach patients how to self-inject
Barriers to implementation include limited experience with prescribing DMPA-SC and changing practice culture to offer it to patients. Additionally, successful implementation of self-administered DMPA-SC is reliant on providing patients with appropriate information and training on self-injection, which requires knowledge, time, and other resources that may be limited in practices. Another potential barrier is product access, as not all insurers cover DMPA-SC and some pharmacies do not carry it.
1. Kennedy CE, Yeh PT, Gaffield ML, et al. Self-administration of injectable contraception: a systematic review and meta-analysis. BMJ Glob Health. 2019;4:e001350. doi: 10.1136/bmjgh-2018-001350
2. Daniels K, Abma J. Current contraceptive status among women aged 15-49: United States, 2017-2019. NCHS Data Brief. 2020;(388):1-8.
3. Paradise SL, Landis CA, Klein DA. Evidence-based contraception: common questions and answers. Am Fam Physician. 2022;106:251-259.
4. Marx M. Evidence‐based guidance for self‐administration of injectable contraception. J Midwifery Womens Health. 2021;66:108-112. doi: 10.1111/jmwh.13190
5. Lindberg LD, VandeVusse A, Mueller J, et al. Early Impacts of the COVID-19 Pandemic: Findings from the 2020 Guttmacher Survey of Reproductive Health Experiences. Guttmacher Institute; 2020. Accessed October 25, 2022. www.guttmacher.org/report/early-impacts-covid-19-pandemic-findings-2020-guttmacher-survey-reproductive-health
6. World Health Organization. WHO consolidated guidance on self-care interventions for health: sexual and reproductive health and rights. Published 2019. Accessed February 14, 2023. https://apps.who.int/iris/bitstream/handle/10665/325480/9789241550550-eng.pdf
7. Curtis KM, Nguyen A, Reeves JA, et al. Update to US selected practice recommendations for contraceptive use: self-administration of subcutaneous depot medroxyprogesterone acetate. MMWR Morb Mortal Wkly Rep. 2021;70:739-743. doi: 10.15585/mmwr.mm7020a2
1. Kennedy CE, Yeh PT, Gaffield ML, et al. Self-administration of injectable contraception: a systematic review and meta-analysis. BMJ Glob Health. 2019;4:e001350. doi: 10.1136/bmjgh-2018-001350
2. Daniels K, Abma J. Current contraceptive status among women aged 15-49: United States, 2017-2019. NCHS Data Brief. 2020;(388):1-8.
3. Paradise SL, Landis CA, Klein DA. Evidence-based contraception: common questions and answers. Am Fam Physician. 2022;106:251-259.
4. Marx M. Evidence‐based guidance for self‐administration of injectable contraception. J Midwifery Womens Health. 2021;66:108-112. doi: 10.1111/jmwh.13190
5. Lindberg LD, VandeVusse A, Mueller J, et al. Early Impacts of the COVID-19 Pandemic: Findings from the 2020 Guttmacher Survey of Reproductive Health Experiences. Guttmacher Institute; 2020. Accessed October 25, 2022. www.guttmacher.org/report/early-impacts-covid-19-pandemic-findings-2020-guttmacher-survey-reproductive-health
6. World Health Organization. WHO consolidated guidance on self-care interventions for health: sexual and reproductive health and rights. Published 2019. Accessed February 14, 2023. https://apps.who.int/iris/bitstream/handle/10665/325480/9789241550550-eng.pdf
7. Curtis KM, Nguyen A, Reeves JA, et al. Update to US selected practice recommendations for contraceptive use: self-administration of subcutaneous depot medroxyprogesterone acetate. MMWR Morb Mortal Wkly Rep. 2021;70:739-743. doi: 10.15585/mmwr.mm7020a2
PRACTICE CHANGER
Consider prescribing self-administered subcutaneous depot medroxyprogesterone acetate (DMPA) for contraception instead of provider-administered DMPA. Self-administration improves contraception continuation rates without notable increases in pregnancy or adverse effects.
STRENGTH OF RECOMMENDATION
A: Based on a meta-analysis of randomized controlled trials (RCTs) and cohort studies.1
Kennedy CE, Yeh PT, Gaffield ML, et al. Self-administration of injectable contraception: a systematic review and meta-analysis. BMJ Glob Health. 2019;4:e001350. doi: 10.1136/bmjgh-2018-001350
Midwife-led care linked to positive outcomes across medical risk levels
Midwives provide safe primary care for pregnant women who are at various levels of medical risk in British Columbia, Canada, new data suggest.
In most cases, for midwifery clients, birth outcomes were similar to or were better than birth outcomes of patients who had physician-led or obstetrician-led care.
In addition, midwifery clients were less likely to experience preterm births or have low-birth-weight babies and to experience cesarean deliveries or births involving instruments.
“Based on previous research, we know that midwives provide safe care for healthy childbearing people or those with no or few risk factors that might complicate the pregnancy or birth,” lead author Kathrin Stoll, PhD, a research associate in the University of British Columbia’s department of family practice, told this news organization.
“What we didn’t know until now is whether midwives provide safe care to people with moderate and high medical risks and what proportion of B.C. [British Columbia] midwifery clients are low, moderate, and high risk,” she said. “This is important to know because of the misperception that midwives only look after low-risk people. This misperception is sometimes used against midwives to justify giving them fewer resources and supports.”
The study was published in the Canadian Medical Association Journal.
Increasing demand
Registered midwives have been part of the health care system in British Columbia since 1998, according to the study authors. The number of pregnant people who are attended by midwives during birth has steadily increased from 4.8% in 2004-2005 to 15.6% in 2019-2020.
The investigators analyzed 2008-2018 data from the British Columbia Perinatal Data Registry, which contains data for 99% of births, including home births. Their analysis included 425,056 births for which a family physician, an obstetrician, or a midwife was listed as the most responsible provider (MRP). The investigators assessed pregnancy risk status (low, moderate, or high), which was determined on the basis of an adapted perinatal risk scoring system used by the Alberta Perinatal Health Program. They estimated the differences in neonatal and maternal outcomes between MRP groups by calculating adjusted absolute and relative risks.
Among the 425,056 births, 63,151 (14.9%) had a midwife as the MRP, 189,679 (44.6%) had a family physician, and 172,226 (40.5%) had an obstetrician. The antenatal risk score ranged from 0 to 23 (median score, 2).
The proportion of births with midwife-led care increased from 9.2% to 19.8% from 2008-2018. In 2018, midwives were listed as the MRP for 24.3% of low-risk, 14.3% of moderate-risk, and 7.9% of high-risk births in the province. This represented an absolute increase of 9.1% for low-risk, 7.7% for moderate-risk, and 5.7% for high-risk births during the study period.
Among the 12,169 at-home births that took place during the study period, 9,776 (80.3%) were low-risk, 2,329 (19.1%) were moderate-risk, and 64 (0.5%) were high-risk births. As the risk score increased, so did the proportion of midwifery and family physician clients who were delivered by obstetricians. Across all risk strata, more family physician clients than midwifery clients underwent deliveries by obstetricians.
Overall, the risk of perinatal death for midwifery clients was similar to the risk for those under the care of family physicians across all risk levels. Low- and moderate-risk clients with midwife-led care were significantly less likely to experience a perinatal death, compared with those with obstetrician-led care, although the adjusted absolute risk differences were small. In the high-risk group, there was no significant difference in the rate of perinatal deaths between midwife-led and physician-led care.
In addition, clients with midwife-led care were significantly less likely to experience preterm birth and have a low-birth-weight baby regardless of medical risk level. The adjusted relative risk of an Apgar score of less than 7 at 5 minutes was significantly lower for midwife-led care than for physician-led care for nearly all comparisons.
The cesarean delivery rate among midwifery clients in the low-risk group was 7.2%, compared with 12.2% for family physicians and 42.3% for obstetrician clients. Cesarean delivery rates increased for midwifery clients as medical risk increased but were significantly lower than the physician rates across all medical risk levels.
Among low-risk clients, the absolute risk reduction for cesarean delivery was 34.4% with midwife-led care, compared with obstetrician-led care. The absolute risk difference increased to 55.3% for moderate-risk clients and to 42.2% for high-risk clients.
Labor induction varied
Although low-risk midwifery clients were significantly less likely to experience labor induction with oxytocin, high-risk midwifery clients were more than twice as likely to undergo induction with oxytocin than obstetrician clients (adjusted absolute difference, 11.3%).
For most risk levels, midwifery clients were less likely to have an assisted vaginal birth than physician clients, and they were significantly more likely to have a spontaneous vaginal birth. Low-risk clients who had a midwife as the MRP were nearly twice as likely to have a spontaneous vaginal birth than obstetricians’ clients, and moderate-risk clients were nearly four times as likely to have a spontaneous vaginal birth.
The rates of vaginal birth after cesarean delivery (VBAC) were significantly higher when a midwife was the MRP. In comparing midwifery clients with family physician clients, the relative and absolute differences were small, but they were larger when comparing midwifery clients with obstetrician clients. Among low-risk clients, the VBAC rate was 85.3% among midwifery clients, compared with 78.6% among family physician clients and 51.5% among obstetrician clients.
In general, the prevalence rates of adverse maternal outcomes (including blood transfusion, intensive care admissions, uterine rupture, and postpartum wound infection) were low for midwifery clients across all risk levels.
Breast- or chest-feeding at birth was significantly more common among midwifery clients across all risk levels as well.
Today, nearly 1 in 4 childbearing people in British Columbia receive care from a midwife at some point during pregnancy, birth, or the postpartum period, the study authors write. During the past 20 years, the profile of clients has evolved to include more moderate- and high-risk patients.
“Clients with more complex medical needs take more time and need more support,” said Dr. Stoll. “This means that midwives continue to stay on call, responding to pages and urgent medical concerns for their clients with no pay for being on call, no days off even for sick days, and unsafe working hours, often working more than 24 hours at a time. If we want to expand midwifery to communities where they are needed most, we need to provide an enabling environment.”
Additional studies are needed as to how different practice and remuneration models affect clinical outcomes, health care costs, and client and provider experiences, the study authors write. At the same time, there are several barriers to obtaining funding, conducting studies, and publishing research by and about midwives in Canada, Dr. Stoll said – barriers that she and her co-authors faced.
Seeking broader access
Alixandra Bacon, a registered midwife and president of the Canadian Association of Midwives, said, “These findings demonstrate that pregnant people at any level of medical risk can benefit from midwifery care. This is a testament both to the benefits of the Canadian midwifery model of care and to the seamless integration of midwifery into collaborative teams and the health system.” Ms. Bacon wasn’t involved with this study.
“If we can realize our goal of equitable access to midwifery care for all families in Canada, we can help to decrease rates of unnecessary medical intervention, preterm labor, and stillbirth,” she added.
“Midwifery is well established across most of Canada. This is yet one more piece of evidence that shows the clinical benefits of midwifery care,” Jasmin Tecson, a registered midwife and president of the Association of Ontario Midwives, said in an interview.
Ms. Tecson, who wasn’t involved with this study, noted the increasing number of clients with more complex health and social needs in Ontario. “It is time to think about how the skills and knowledge of midwives can be used with clients of different risk profiles and how the current scope of practice of midwives can be optimized and expanded,” she said. “For example, Ontario midwives are still required to prescribe medications from a limited list, despite the potential additional clinical risks and health system costs that this creates.”
The study received financial support from the University of British Columbia Stollery Fund and the University of British Columbia Work Learn Program. Dr. Stoll has an unpaid role with the Midwives Association Contract Negotiation Advisory Council. Ms. Bacon and Ms. Tecson disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Midwives provide safe primary care for pregnant women who are at various levels of medical risk in British Columbia, Canada, new data suggest.
In most cases, for midwifery clients, birth outcomes were similar to or were better than birth outcomes of patients who had physician-led or obstetrician-led care.
In addition, midwifery clients were less likely to experience preterm births or have low-birth-weight babies and to experience cesarean deliveries or births involving instruments.
“Based on previous research, we know that midwives provide safe care for healthy childbearing people or those with no or few risk factors that might complicate the pregnancy or birth,” lead author Kathrin Stoll, PhD, a research associate in the University of British Columbia’s department of family practice, told this news organization.
“What we didn’t know until now is whether midwives provide safe care to people with moderate and high medical risks and what proportion of B.C. [British Columbia] midwifery clients are low, moderate, and high risk,” she said. “This is important to know because of the misperception that midwives only look after low-risk people. This misperception is sometimes used against midwives to justify giving them fewer resources and supports.”
The study was published in the Canadian Medical Association Journal.
Increasing demand
Registered midwives have been part of the health care system in British Columbia since 1998, according to the study authors. The number of pregnant people who are attended by midwives during birth has steadily increased from 4.8% in 2004-2005 to 15.6% in 2019-2020.
The investigators analyzed 2008-2018 data from the British Columbia Perinatal Data Registry, which contains data for 99% of births, including home births. Their analysis included 425,056 births for which a family physician, an obstetrician, or a midwife was listed as the most responsible provider (MRP). The investigators assessed pregnancy risk status (low, moderate, or high), which was determined on the basis of an adapted perinatal risk scoring system used by the Alberta Perinatal Health Program. They estimated the differences in neonatal and maternal outcomes between MRP groups by calculating adjusted absolute and relative risks.
Among the 425,056 births, 63,151 (14.9%) had a midwife as the MRP, 189,679 (44.6%) had a family physician, and 172,226 (40.5%) had an obstetrician. The antenatal risk score ranged from 0 to 23 (median score, 2).
The proportion of births with midwife-led care increased from 9.2% to 19.8% from 2008-2018. In 2018, midwives were listed as the MRP for 24.3% of low-risk, 14.3% of moderate-risk, and 7.9% of high-risk births in the province. This represented an absolute increase of 9.1% for low-risk, 7.7% for moderate-risk, and 5.7% for high-risk births during the study period.
Among the 12,169 at-home births that took place during the study period, 9,776 (80.3%) were low-risk, 2,329 (19.1%) were moderate-risk, and 64 (0.5%) were high-risk births. As the risk score increased, so did the proportion of midwifery and family physician clients who were delivered by obstetricians. Across all risk strata, more family physician clients than midwifery clients underwent deliveries by obstetricians.
Overall, the risk of perinatal death for midwifery clients was similar to the risk for those under the care of family physicians across all risk levels. Low- and moderate-risk clients with midwife-led care were significantly less likely to experience a perinatal death, compared with those with obstetrician-led care, although the adjusted absolute risk differences were small. In the high-risk group, there was no significant difference in the rate of perinatal deaths between midwife-led and physician-led care.
In addition, clients with midwife-led care were significantly less likely to experience preterm birth and have a low-birth-weight baby regardless of medical risk level. The adjusted relative risk of an Apgar score of less than 7 at 5 minutes was significantly lower for midwife-led care than for physician-led care for nearly all comparisons.
The cesarean delivery rate among midwifery clients in the low-risk group was 7.2%, compared with 12.2% for family physicians and 42.3% for obstetrician clients. Cesarean delivery rates increased for midwifery clients as medical risk increased but were significantly lower than the physician rates across all medical risk levels.
Among low-risk clients, the absolute risk reduction for cesarean delivery was 34.4% with midwife-led care, compared with obstetrician-led care. The absolute risk difference increased to 55.3% for moderate-risk clients and to 42.2% for high-risk clients.
Labor induction varied
Although low-risk midwifery clients were significantly less likely to experience labor induction with oxytocin, high-risk midwifery clients were more than twice as likely to undergo induction with oxytocin than obstetrician clients (adjusted absolute difference, 11.3%).
For most risk levels, midwifery clients were less likely to have an assisted vaginal birth than physician clients, and they were significantly more likely to have a spontaneous vaginal birth. Low-risk clients who had a midwife as the MRP were nearly twice as likely to have a spontaneous vaginal birth than obstetricians’ clients, and moderate-risk clients were nearly four times as likely to have a spontaneous vaginal birth.
The rates of vaginal birth after cesarean delivery (VBAC) were significantly higher when a midwife was the MRP. In comparing midwifery clients with family physician clients, the relative and absolute differences were small, but they were larger when comparing midwifery clients with obstetrician clients. Among low-risk clients, the VBAC rate was 85.3% among midwifery clients, compared with 78.6% among family physician clients and 51.5% among obstetrician clients.
In general, the prevalence rates of adverse maternal outcomes (including blood transfusion, intensive care admissions, uterine rupture, and postpartum wound infection) were low for midwifery clients across all risk levels.
Breast- or chest-feeding at birth was significantly more common among midwifery clients across all risk levels as well.
Today, nearly 1 in 4 childbearing people in British Columbia receive care from a midwife at some point during pregnancy, birth, or the postpartum period, the study authors write. During the past 20 years, the profile of clients has evolved to include more moderate- and high-risk patients.
“Clients with more complex medical needs take more time and need more support,” said Dr. Stoll. “This means that midwives continue to stay on call, responding to pages and urgent medical concerns for their clients with no pay for being on call, no days off even for sick days, and unsafe working hours, often working more than 24 hours at a time. If we want to expand midwifery to communities where they are needed most, we need to provide an enabling environment.”
Additional studies are needed as to how different practice and remuneration models affect clinical outcomes, health care costs, and client and provider experiences, the study authors write. At the same time, there are several barriers to obtaining funding, conducting studies, and publishing research by and about midwives in Canada, Dr. Stoll said – barriers that she and her co-authors faced.
Seeking broader access
Alixandra Bacon, a registered midwife and president of the Canadian Association of Midwives, said, “These findings demonstrate that pregnant people at any level of medical risk can benefit from midwifery care. This is a testament both to the benefits of the Canadian midwifery model of care and to the seamless integration of midwifery into collaborative teams and the health system.” Ms. Bacon wasn’t involved with this study.
“If we can realize our goal of equitable access to midwifery care for all families in Canada, we can help to decrease rates of unnecessary medical intervention, preterm labor, and stillbirth,” she added.
“Midwifery is well established across most of Canada. This is yet one more piece of evidence that shows the clinical benefits of midwifery care,” Jasmin Tecson, a registered midwife and president of the Association of Ontario Midwives, said in an interview.
Ms. Tecson, who wasn’t involved with this study, noted the increasing number of clients with more complex health and social needs in Ontario. “It is time to think about how the skills and knowledge of midwives can be used with clients of different risk profiles and how the current scope of practice of midwives can be optimized and expanded,” she said. “For example, Ontario midwives are still required to prescribe medications from a limited list, despite the potential additional clinical risks and health system costs that this creates.”
The study received financial support from the University of British Columbia Stollery Fund and the University of British Columbia Work Learn Program. Dr. Stoll has an unpaid role with the Midwives Association Contract Negotiation Advisory Council. Ms. Bacon and Ms. Tecson disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Midwives provide safe primary care for pregnant women who are at various levels of medical risk in British Columbia, Canada, new data suggest.
In most cases, for midwifery clients, birth outcomes were similar to or were better than birth outcomes of patients who had physician-led or obstetrician-led care.
In addition, midwifery clients were less likely to experience preterm births or have low-birth-weight babies and to experience cesarean deliveries or births involving instruments.
“Based on previous research, we know that midwives provide safe care for healthy childbearing people or those with no or few risk factors that might complicate the pregnancy or birth,” lead author Kathrin Stoll, PhD, a research associate in the University of British Columbia’s department of family practice, told this news organization.
“What we didn’t know until now is whether midwives provide safe care to people with moderate and high medical risks and what proportion of B.C. [British Columbia] midwifery clients are low, moderate, and high risk,” she said. “This is important to know because of the misperception that midwives only look after low-risk people. This misperception is sometimes used against midwives to justify giving them fewer resources and supports.”
The study was published in the Canadian Medical Association Journal.
Increasing demand
Registered midwives have been part of the health care system in British Columbia since 1998, according to the study authors. The number of pregnant people who are attended by midwives during birth has steadily increased from 4.8% in 2004-2005 to 15.6% in 2019-2020.
The investigators analyzed 2008-2018 data from the British Columbia Perinatal Data Registry, which contains data for 99% of births, including home births. Their analysis included 425,056 births for which a family physician, an obstetrician, or a midwife was listed as the most responsible provider (MRP). The investigators assessed pregnancy risk status (low, moderate, or high), which was determined on the basis of an adapted perinatal risk scoring system used by the Alberta Perinatal Health Program. They estimated the differences in neonatal and maternal outcomes between MRP groups by calculating adjusted absolute and relative risks.
Among the 425,056 births, 63,151 (14.9%) had a midwife as the MRP, 189,679 (44.6%) had a family physician, and 172,226 (40.5%) had an obstetrician. The antenatal risk score ranged from 0 to 23 (median score, 2).
The proportion of births with midwife-led care increased from 9.2% to 19.8% from 2008-2018. In 2018, midwives were listed as the MRP for 24.3% of low-risk, 14.3% of moderate-risk, and 7.9% of high-risk births in the province. This represented an absolute increase of 9.1% for low-risk, 7.7% for moderate-risk, and 5.7% for high-risk births during the study period.
Among the 12,169 at-home births that took place during the study period, 9,776 (80.3%) were low-risk, 2,329 (19.1%) were moderate-risk, and 64 (0.5%) were high-risk births. As the risk score increased, so did the proportion of midwifery and family physician clients who were delivered by obstetricians. Across all risk strata, more family physician clients than midwifery clients underwent deliveries by obstetricians.
Overall, the risk of perinatal death for midwifery clients was similar to the risk for those under the care of family physicians across all risk levels. Low- and moderate-risk clients with midwife-led care were significantly less likely to experience a perinatal death, compared with those with obstetrician-led care, although the adjusted absolute risk differences were small. In the high-risk group, there was no significant difference in the rate of perinatal deaths between midwife-led and physician-led care.
In addition, clients with midwife-led care were significantly less likely to experience preterm birth and have a low-birth-weight baby regardless of medical risk level. The adjusted relative risk of an Apgar score of less than 7 at 5 minutes was significantly lower for midwife-led care than for physician-led care for nearly all comparisons.
The cesarean delivery rate among midwifery clients in the low-risk group was 7.2%, compared with 12.2% for family physicians and 42.3% for obstetrician clients. Cesarean delivery rates increased for midwifery clients as medical risk increased but were significantly lower than the physician rates across all medical risk levels.
Among low-risk clients, the absolute risk reduction for cesarean delivery was 34.4% with midwife-led care, compared with obstetrician-led care. The absolute risk difference increased to 55.3% for moderate-risk clients and to 42.2% for high-risk clients.
Labor induction varied
Although low-risk midwifery clients were significantly less likely to experience labor induction with oxytocin, high-risk midwifery clients were more than twice as likely to undergo induction with oxytocin than obstetrician clients (adjusted absolute difference, 11.3%).
For most risk levels, midwifery clients were less likely to have an assisted vaginal birth than physician clients, and they were significantly more likely to have a spontaneous vaginal birth. Low-risk clients who had a midwife as the MRP were nearly twice as likely to have a spontaneous vaginal birth than obstetricians’ clients, and moderate-risk clients were nearly four times as likely to have a spontaneous vaginal birth.
The rates of vaginal birth after cesarean delivery (VBAC) were significantly higher when a midwife was the MRP. In comparing midwifery clients with family physician clients, the relative and absolute differences were small, but they were larger when comparing midwifery clients with obstetrician clients. Among low-risk clients, the VBAC rate was 85.3% among midwifery clients, compared with 78.6% among family physician clients and 51.5% among obstetrician clients.
In general, the prevalence rates of adverse maternal outcomes (including blood transfusion, intensive care admissions, uterine rupture, and postpartum wound infection) were low for midwifery clients across all risk levels.
Breast- or chest-feeding at birth was significantly more common among midwifery clients across all risk levels as well.
Today, nearly 1 in 4 childbearing people in British Columbia receive care from a midwife at some point during pregnancy, birth, or the postpartum period, the study authors write. During the past 20 years, the profile of clients has evolved to include more moderate- and high-risk patients.
“Clients with more complex medical needs take more time and need more support,” said Dr. Stoll. “This means that midwives continue to stay on call, responding to pages and urgent medical concerns for their clients with no pay for being on call, no days off even for sick days, and unsafe working hours, often working more than 24 hours at a time. If we want to expand midwifery to communities where they are needed most, we need to provide an enabling environment.”
Additional studies are needed as to how different practice and remuneration models affect clinical outcomes, health care costs, and client and provider experiences, the study authors write. At the same time, there are several barriers to obtaining funding, conducting studies, and publishing research by and about midwives in Canada, Dr. Stoll said – barriers that she and her co-authors faced.
Seeking broader access
Alixandra Bacon, a registered midwife and president of the Canadian Association of Midwives, said, “These findings demonstrate that pregnant people at any level of medical risk can benefit from midwifery care. This is a testament both to the benefits of the Canadian midwifery model of care and to the seamless integration of midwifery into collaborative teams and the health system.” Ms. Bacon wasn’t involved with this study.
“If we can realize our goal of equitable access to midwifery care for all families in Canada, we can help to decrease rates of unnecessary medical intervention, preterm labor, and stillbirth,” she added.
“Midwifery is well established across most of Canada. This is yet one more piece of evidence that shows the clinical benefits of midwifery care,” Jasmin Tecson, a registered midwife and president of the Association of Ontario Midwives, said in an interview.
Ms. Tecson, who wasn’t involved with this study, noted the increasing number of clients with more complex health and social needs in Ontario. “It is time to think about how the skills and knowledge of midwives can be used with clients of different risk profiles and how the current scope of practice of midwives can be optimized and expanded,” she said. “For example, Ontario midwives are still required to prescribe medications from a limited list, despite the potential additional clinical risks and health system costs that this creates.”
The study received financial support from the University of British Columbia Stollery Fund and the University of British Columbia Work Learn Program. Dr. Stoll has an unpaid role with the Midwives Association Contract Negotiation Advisory Council. Ms. Bacon and Ms. Tecson disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Black women have higher state-level rates of TNBC
New national data on the occurrence of triple-negative breast cancer (TNBC) among different racial groups confirms that the disease is more common among Black women nationwide. A state-by-state analysis in the study, published online in JAMA Oncology, shows that these trends persist at the state level.
The analysis revealed that incidence rate ratios of TNBC were significantly higher among Black women, compared with White women, in all states with data on this population. Rates ranged from a low of 1.38 in Colorado to a high of 2.32 in Delaware.
The state-level disparities highlight gaps in physicians’ understanding of how social factors contribute to disparities in TNBC risk and the need “to develop effective preventative measures,” the study authors explain.
“We’ve realized for a long time that Black women have a higher incidence of TNBC. This is related to the genetic signature of the cancer. So that is not at all surprising,” said Arnold M. Baskies, MD, past chairman of the national board of directors of the American Cancer Society, Atlanta, who was not involved in the research. However, “the variance of TNBC among women from state to state is somewhat surprising.”
Existing research shows that TNBC is diagnosed more frequently among non-Hispanic Black women than among other populations in the United States, but it’s unclear whether these racial and ethnic disparities differ at the state level.
The authors identified 133,579 women with TNBC from the U.S. Cancer Statistics Public Use Research Database whose conditions were diagnosed from January 2015 through the end of December 2019. Most patients (64.5%) were White, 21.5% were Black, nearly 10% were Hispanic, 3.7% were Asian or Pacific Islander, and 0.6% were American Indian or Alaska Native. States with fewer than 30 cases were excluded, as was Nevada, owing to concerns regarding data quality. That left eight states for American Indian or Alaska Natives, 22 for Asian or Pacific Islanders, 35 for Hispanic women, 38 for Black women, and 50 for White women.
Overall, the incidence ratios of TNBC were highest among Black women (IR, 25.2 per 100,000), followed by White women (IR, 12.9 per 100,000), American Indian or Alaska Native women (IR, 11.2 per 100,000), Hispanic women (IR, 11.1 per 100,000 women), and Asian or Pacific Islander (IR, 9.0 per 100,000) women.
The authors also uncovered significant state-by-state variations in TNBC incidence by racial and ethnic groups. The lowest IR rates occurred among Asian or Pacific Islander women in Oregon and Pennsylvania – fewer than 7 per 100,000 women – and the highest occurred among Black women in Delaware, Missouri, Louisiana, and Mississippi – more than 29 per 100,000 women.
In the 38 states for which data on Black women were available, IR rates were significantly higher among Black women in all 38, compared with White women. The IR rates ranged from a low of 1.38 (IR, 17.4 per 100 000 women) in Colorado to a high of 2.32 (IR, 32.0 per 100 000 women) in Delaware.
While genetics play a role in TNBC risk, “the substantial geographic variation we found within each racial and ethnic group is highly suggestive that there are structural, environmental, and social factors at play in determining women’s risk of TNBC,” said lead study author Hyuna Sung, PhD, senior principal scientist and cancer epidemiologist at the American Cancer Society, Atlanta.
Existing evidence indicates that Black and White women living in socioeconomically disadvantaged neighborhoods are at higher risk of developing more aggressive subtypes of breast cancer, Dr. Sung said. Another factor, Dr. Sung and co-authors note, is breastfeeding. Across races, women who breastfeed have lower rates of TNBC.
Getting more definitive answers as to what causes differences in TNBC rates across states and what strategies can help reduce these disparities will be difficult and requires more research. “We really need to do a better job at researching and treating TNBC to improve health care equality for all women,” Dr. Baskies said. “The mortality rates from this cancer are high, and we rely heavily on surgery and toxic chemotherapy to treat it.”
Dr. Sung agreed, noting that “the observed state variation in TNBC rates merits further studies with risk factor data at multiple levels to better understand the associations of social exposures with the risk of TNBC.”
In states such as Louisiana and Mississippi, which are known to have a disproportionately higher burden of many types of cancers, “addressing barriers to access to preventive care and empowering public health efforts to promote a healthy living environment are the best policy prescription that could be deduced from our results,” Dr. Sung concluded.
Dr. Baskies is on the board of directors of Anixa Biosciences, which is currently conducting a clinical trial of a TNBC vaccine at the Cleveland Clinic. Dr. Sung has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New national data on the occurrence of triple-negative breast cancer (TNBC) among different racial groups confirms that the disease is more common among Black women nationwide. A state-by-state analysis in the study, published online in JAMA Oncology, shows that these trends persist at the state level.
The analysis revealed that incidence rate ratios of TNBC were significantly higher among Black women, compared with White women, in all states with data on this population. Rates ranged from a low of 1.38 in Colorado to a high of 2.32 in Delaware.
The state-level disparities highlight gaps in physicians’ understanding of how social factors contribute to disparities in TNBC risk and the need “to develop effective preventative measures,” the study authors explain.
“We’ve realized for a long time that Black women have a higher incidence of TNBC. This is related to the genetic signature of the cancer. So that is not at all surprising,” said Arnold M. Baskies, MD, past chairman of the national board of directors of the American Cancer Society, Atlanta, who was not involved in the research. However, “the variance of TNBC among women from state to state is somewhat surprising.”
Existing research shows that TNBC is diagnosed more frequently among non-Hispanic Black women than among other populations in the United States, but it’s unclear whether these racial and ethnic disparities differ at the state level.
The authors identified 133,579 women with TNBC from the U.S. Cancer Statistics Public Use Research Database whose conditions were diagnosed from January 2015 through the end of December 2019. Most patients (64.5%) were White, 21.5% were Black, nearly 10% were Hispanic, 3.7% were Asian or Pacific Islander, and 0.6% were American Indian or Alaska Native. States with fewer than 30 cases were excluded, as was Nevada, owing to concerns regarding data quality. That left eight states for American Indian or Alaska Natives, 22 for Asian or Pacific Islanders, 35 for Hispanic women, 38 for Black women, and 50 for White women.
Overall, the incidence ratios of TNBC were highest among Black women (IR, 25.2 per 100,000), followed by White women (IR, 12.9 per 100,000), American Indian or Alaska Native women (IR, 11.2 per 100,000), Hispanic women (IR, 11.1 per 100,000 women), and Asian or Pacific Islander (IR, 9.0 per 100,000) women.
The authors also uncovered significant state-by-state variations in TNBC incidence by racial and ethnic groups. The lowest IR rates occurred among Asian or Pacific Islander women in Oregon and Pennsylvania – fewer than 7 per 100,000 women – and the highest occurred among Black women in Delaware, Missouri, Louisiana, and Mississippi – more than 29 per 100,000 women.
In the 38 states for which data on Black women were available, IR rates were significantly higher among Black women in all 38, compared with White women. The IR rates ranged from a low of 1.38 (IR, 17.4 per 100 000 women) in Colorado to a high of 2.32 (IR, 32.0 per 100 000 women) in Delaware.
While genetics play a role in TNBC risk, “the substantial geographic variation we found within each racial and ethnic group is highly suggestive that there are structural, environmental, and social factors at play in determining women’s risk of TNBC,” said lead study author Hyuna Sung, PhD, senior principal scientist and cancer epidemiologist at the American Cancer Society, Atlanta.
Existing evidence indicates that Black and White women living in socioeconomically disadvantaged neighborhoods are at higher risk of developing more aggressive subtypes of breast cancer, Dr. Sung said. Another factor, Dr. Sung and co-authors note, is breastfeeding. Across races, women who breastfeed have lower rates of TNBC.
Getting more definitive answers as to what causes differences in TNBC rates across states and what strategies can help reduce these disparities will be difficult and requires more research. “We really need to do a better job at researching and treating TNBC to improve health care equality for all women,” Dr. Baskies said. “The mortality rates from this cancer are high, and we rely heavily on surgery and toxic chemotherapy to treat it.”
Dr. Sung agreed, noting that “the observed state variation in TNBC rates merits further studies with risk factor data at multiple levels to better understand the associations of social exposures with the risk of TNBC.”
In states such as Louisiana and Mississippi, which are known to have a disproportionately higher burden of many types of cancers, “addressing barriers to access to preventive care and empowering public health efforts to promote a healthy living environment are the best policy prescription that could be deduced from our results,” Dr. Sung concluded.
Dr. Baskies is on the board of directors of Anixa Biosciences, which is currently conducting a clinical trial of a TNBC vaccine at the Cleveland Clinic. Dr. Sung has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New national data on the occurrence of triple-negative breast cancer (TNBC) among different racial groups confirms that the disease is more common among Black women nationwide. A state-by-state analysis in the study, published online in JAMA Oncology, shows that these trends persist at the state level.
The analysis revealed that incidence rate ratios of TNBC were significantly higher among Black women, compared with White women, in all states with data on this population. Rates ranged from a low of 1.38 in Colorado to a high of 2.32 in Delaware.
The state-level disparities highlight gaps in physicians’ understanding of how social factors contribute to disparities in TNBC risk and the need “to develop effective preventative measures,” the study authors explain.
“We’ve realized for a long time that Black women have a higher incidence of TNBC. This is related to the genetic signature of the cancer. So that is not at all surprising,” said Arnold M. Baskies, MD, past chairman of the national board of directors of the American Cancer Society, Atlanta, who was not involved in the research. However, “the variance of TNBC among women from state to state is somewhat surprising.”
Existing research shows that TNBC is diagnosed more frequently among non-Hispanic Black women than among other populations in the United States, but it’s unclear whether these racial and ethnic disparities differ at the state level.
The authors identified 133,579 women with TNBC from the U.S. Cancer Statistics Public Use Research Database whose conditions were diagnosed from January 2015 through the end of December 2019. Most patients (64.5%) were White, 21.5% were Black, nearly 10% were Hispanic, 3.7% were Asian or Pacific Islander, and 0.6% were American Indian or Alaska Native. States with fewer than 30 cases were excluded, as was Nevada, owing to concerns regarding data quality. That left eight states for American Indian or Alaska Natives, 22 for Asian or Pacific Islanders, 35 for Hispanic women, 38 for Black women, and 50 for White women.
Overall, the incidence ratios of TNBC were highest among Black women (IR, 25.2 per 100,000), followed by White women (IR, 12.9 per 100,000), American Indian or Alaska Native women (IR, 11.2 per 100,000), Hispanic women (IR, 11.1 per 100,000 women), and Asian or Pacific Islander (IR, 9.0 per 100,000) women.
The authors also uncovered significant state-by-state variations in TNBC incidence by racial and ethnic groups. The lowest IR rates occurred among Asian or Pacific Islander women in Oregon and Pennsylvania – fewer than 7 per 100,000 women – and the highest occurred among Black women in Delaware, Missouri, Louisiana, and Mississippi – more than 29 per 100,000 women.
In the 38 states for which data on Black women were available, IR rates were significantly higher among Black women in all 38, compared with White women. The IR rates ranged from a low of 1.38 (IR, 17.4 per 100 000 women) in Colorado to a high of 2.32 (IR, 32.0 per 100 000 women) in Delaware.
While genetics play a role in TNBC risk, “the substantial geographic variation we found within each racial and ethnic group is highly suggestive that there are structural, environmental, and social factors at play in determining women’s risk of TNBC,” said lead study author Hyuna Sung, PhD, senior principal scientist and cancer epidemiologist at the American Cancer Society, Atlanta.
Existing evidence indicates that Black and White women living in socioeconomically disadvantaged neighborhoods are at higher risk of developing more aggressive subtypes of breast cancer, Dr. Sung said. Another factor, Dr. Sung and co-authors note, is breastfeeding. Across races, women who breastfeed have lower rates of TNBC.
Getting more definitive answers as to what causes differences in TNBC rates across states and what strategies can help reduce these disparities will be difficult and requires more research. “We really need to do a better job at researching and treating TNBC to improve health care equality for all women,” Dr. Baskies said. “The mortality rates from this cancer are high, and we rely heavily on surgery and toxic chemotherapy to treat it.”
Dr. Sung agreed, noting that “the observed state variation in TNBC rates merits further studies with risk factor data at multiple levels to better understand the associations of social exposures with the risk of TNBC.”
In states such as Louisiana and Mississippi, which are known to have a disproportionately higher burden of many types of cancers, “addressing barriers to access to preventive care and empowering public health efforts to promote a healthy living environment are the best policy prescription that could be deduced from our results,” Dr. Sung concluded.
Dr. Baskies is on the board of directors of Anixa Biosciences, which is currently conducting a clinical trial of a TNBC vaccine at the Cleveland Clinic. Dr. Sung has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For young people on Medicare, a hysterectomy sometimes is more affordable than birth control
Sam Chavarría said her doctor was clear about the birth defects her medication could cause if she became pregnant but agreed to keep her on it as long as she had an IUD.
As she was waiting to get her contraceptive intrauterine device replaced at her local clinic, however, the billing nurse told her that her insurance wouldn’t cover the removal – or a new IUD. Chavarría didn’t understand why not.
“Then she said very delicately, ‘Well, people on this insurance typically tend to be older,’ ” Chavarría recalled.
Although Chavarría is 34, she is enrolled in Medicare, the government insurance program designed for those 65 and older. Chavarría, who lives in Houston, is disabled by fibromyalgia, rheumatoid arthritis, and mental health issues. Medicare automatically enrolls anyone who has received Social Security disability benefits for two years and this was her first time getting an IUD while in the government program.
Without insurance, just removing her expired IUD would cost Chavarría $350 out of pocket; exchanging it for a new one would be $2,000. She left the clinic in tears.
Chavarría’s experience is not rare. Medicare was originally intended for people of retirement age. Over the years, the program has evolved to include new populations, such as those who have disabilities or are critically ill, said Jennifer Lea Huer, a public health expert at Yale University, New Haven, Conn. In 2020, 1.7 million people ages 18-44 were enrolled in Medicare.
An estimated 70% of childbearing-age women on Medicare are also eligible for Medicaid, a state and federal program for those with low incomes, which should fill the gap for contraception. It’s not clear how many transgender or nonbinary people – who also might need contraception – are on Medicare or are eligible for Medicaid.
Medicaid, like the plans offered via the federal Affordable Care Act, mandates coverage of birth control. But those who aren’t eligible for Medicaid are left in the lurch – Medicare’s origins mean it does not require access to birth control.
Traditional Medicare includes two parts: Part A covers hospital costs, while Part B covers physicians’ care and certain other services, such as ambulance rides. Neither ordinarily includes contraception.
People can get contraception through a Medicare Advantage plan or Part D of Medicare, which covers prescription drugs, but those come at a cost. And even people who pay for Part D often aren’t covered for some types of birth control, such as IUDs.
“So, if you are disabled, if you are locked outside of the labor market, if you do not have the means or any other way to financially support yourself, you were likely still on traditional Medicare, which is Part A and Part B,” Huer said. “In which case, your access to contraception is incredibly difficult.”
Contraception for those with traditional Medicare is given on a case-by-case basis, Huer said. It can be covered only if a doctor can make a credible case that the patient needs it for medical reasons – because their body cannot sustain a pregnancy – as opposed to merely wanting to avoid one.
“You have to have a champion physician who’s willing to partner with you and make those arguments,” Huer said.
That’s what Chavarría’s doctor tried to do. Before she left the clinic, staffers there told her they would try to make the case she needed the IUD for medical reasons. The IUD exchange was scheduled almost 10 weeks later, but during those weeks, she got pregnant. Her body couldn’t sustain a pregnancy, so she and her partner rushed to get an abortion just before Texas tightened its rules Sept. 1, 2021.
“If Medicare had just covered the IUD removal or exchange to begin with, none of this would have happened,” Chavarría said. “It would have saved me having to make a really tough decision that I never thought I’d have to make.”
Women with disabilities often face a stigma from health care practitioners, especially when it comes to birth control, said Willi Horner-Johnson, a public health researcher specializing in disabilities at Oregon Health & Science University, Portland. In her research, women with disabilities have described being treated like children or having to go to multiple doctors to find someone with whom they felt comfortable.
“We don’t want to acknowledge that disabled people have sex,” said Miriam Garber, a 36-year-old sex worker who lives in Rhode Island and is also on Medicare because of her disabilities. Garber got an IUD from Planned Parenthood because her insurance wouldn’t cover it.
Even those who pay for Part D to have their prescription drugs covered and have a “champion physician” face difficulties. Liz Moore, a nonbinary person in their 30s who lives in the Washington, D.C., area, could not get Medicare to pay for the Mirena IUD their doctor prescribed for their polycystic ovary syndrome. Moore is disabled with fibromyalgia and dysautonomia, a condition of the autonomic nervous system, which regulates breathing, heart rate, and more.
“After literally months of phone calls, it seemed like my Medicare Part D and original Medicare could not agree on who should pay for my IUD,” they wrote in a direct message. “Was it a prescription or durable medical equipment?”
When Moore finally learned it would cost $800 upfront, they said, they decided to get a hysterectomy – which Medicare would pay for – instead.
Chavarría’s doctor told her a tubal ligation also was more likely to be approved by Medicare than an IUD, because older people have that procedure more often. Like all surgeries, both come with risks of complications and recovery.
Even for those on both Medicare and Medicaid, getting contraception also isn’t always easy, as in Katie Elizabeth Walsh’s case.
Walsh, 34, who lives in northeastern Connecticut, is disabled by a traumatic brain injury, depression, and chronic fatigue syndrome. She got an IUD at an ob.gyn. clinic and was told there her insurance would cover it.
Then she got a bill for nearly $2,000.
Medicaid should cover contraceptive devices for dual-eligibility people, according to Centers for Medicare & Medicaid Services policy guidance, but when Walsh tried to get her bill covered, Medicare and Medicaid could not agree on which of them should pay.
“Every single time I have called one of the insurance offices, they are like, ‘Oh, no, you have to talk to the other one, and we don’t really talk to each other,’ ” Walsh said.
Walsh said the hassle to get her contraception covered feels like a kick in the stomach: “Like truly you do not have a place in this world, and your insurance is telling you that.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Sam Chavarría said her doctor was clear about the birth defects her medication could cause if she became pregnant but agreed to keep her on it as long as she had an IUD.
As she was waiting to get her contraceptive intrauterine device replaced at her local clinic, however, the billing nurse told her that her insurance wouldn’t cover the removal – or a new IUD. Chavarría didn’t understand why not.
“Then she said very delicately, ‘Well, people on this insurance typically tend to be older,’ ” Chavarría recalled.
Although Chavarría is 34, she is enrolled in Medicare, the government insurance program designed for those 65 and older. Chavarría, who lives in Houston, is disabled by fibromyalgia, rheumatoid arthritis, and mental health issues. Medicare automatically enrolls anyone who has received Social Security disability benefits for two years and this was her first time getting an IUD while in the government program.
Without insurance, just removing her expired IUD would cost Chavarría $350 out of pocket; exchanging it for a new one would be $2,000. She left the clinic in tears.
Chavarría’s experience is not rare. Medicare was originally intended for people of retirement age. Over the years, the program has evolved to include new populations, such as those who have disabilities or are critically ill, said Jennifer Lea Huer, a public health expert at Yale University, New Haven, Conn. In 2020, 1.7 million people ages 18-44 were enrolled in Medicare.
An estimated 70% of childbearing-age women on Medicare are also eligible for Medicaid, a state and federal program for those with low incomes, which should fill the gap for contraception. It’s not clear how many transgender or nonbinary people – who also might need contraception – are on Medicare or are eligible for Medicaid.
Medicaid, like the plans offered via the federal Affordable Care Act, mandates coverage of birth control. But those who aren’t eligible for Medicaid are left in the lurch – Medicare’s origins mean it does not require access to birth control.
Traditional Medicare includes two parts: Part A covers hospital costs, while Part B covers physicians’ care and certain other services, such as ambulance rides. Neither ordinarily includes contraception.
People can get contraception through a Medicare Advantage plan or Part D of Medicare, which covers prescription drugs, but those come at a cost. And even people who pay for Part D often aren’t covered for some types of birth control, such as IUDs.
“So, if you are disabled, if you are locked outside of the labor market, if you do not have the means or any other way to financially support yourself, you were likely still on traditional Medicare, which is Part A and Part B,” Huer said. “In which case, your access to contraception is incredibly difficult.”
Contraception for those with traditional Medicare is given on a case-by-case basis, Huer said. It can be covered only if a doctor can make a credible case that the patient needs it for medical reasons – because their body cannot sustain a pregnancy – as opposed to merely wanting to avoid one.
“You have to have a champion physician who’s willing to partner with you and make those arguments,” Huer said.
That’s what Chavarría’s doctor tried to do. Before she left the clinic, staffers there told her they would try to make the case she needed the IUD for medical reasons. The IUD exchange was scheduled almost 10 weeks later, but during those weeks, she got pregnant. Her body couldn’t sustain a pregnancy, so she and her partner rushed to get an abortion just before Texas tightened its rules Sept. 1, 2021.
“If Medicare had just covered the IUD removal or exchange to begin with, none of this would have happened,” Chavarría said. “It would have saved me having to make a really tough decision that I never thought I’d have to make.”
Women with disabilities often face a stigma from health care practitioners, especially when it comes to birth control, said Willi Horner-Johnson, a public health researcher specializing in disabilities at Oregon Health & Science University, Portland. In her research, women with disabilities have described being treated like children or having to go to multiple doctors to find someone with whom they felt comfortable.
“We don’t want to acknowledge that disabled people have sex,” said Miriam Garber, a 36-year-old sex worker who lives in Rhode Island and is also on Medicare because of her disabilities. Garber got an IUD from Planned Parenthood because her insurance wouldn’t cover it.
Even those who pay for Part D to have their prescription drugs covered and have a “champion physician” face difficulties. Liz Moore, a nonbinary person in their 30s who lives in the Washington, D.C., area, could not get Medicare to pay for the Mirena IUD their doctor prescribed for their polycystic ovary syndrome. Moore is disabled with fibromyalgia and dysautonomia, a condition of the autonomic nervous system, which regulates breathing, heart rate, and more.
“After literally months of phone calls, it seemed like my Medicare Part D and original Medicare could not agree on who should pay for my IUD,” they wrote in a direct message. “Was it a prescription or durable medical equipment?”
When Moore finally learned it would cost $800 upfront, they said, they decided to get a hysterectomy – which Medicare would pay for – instead.
Chavarría’s doctor told her a tubal ligation also was more likely to be approved by Medicare than an IUD, because older people have that procedure more often. Like all surgeries, both come with risks of complications and recovery.
Even for those on both Medicare and Medicaid, getting contraception also isn’t always easy, as in Katie Elizabeth Walsh’s case.
Walsh, 34, who lives in northeastern Connecticut, is disabled by a traumatic brain injury, depression, and chronic fatigue syndrome. She got an IUD at an ob.gyn. clinic and was told there her insurance would cover it.
Then she got a bill for nearly $2,000.
Medicaid should cover contraceptive devices for dual-eligibility people, according to Centers for Medicare & Medicaid Services policy guidance, but when Walsh tried to get her bill covered, Medicare and Medicaid could not agree on which of them should pay.
“Every single time I have called one of the insurance offices, they are like, ‘Oh, no, you have to talk to the other one, and we don’t really talk to each other,’ ” Walsh said.
Walsh said the hassle to get her contraception covered feels like a kick in the stomach: “Like truly you do not have a place in this world, and your insurance is telling you that.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Sam Chavarría said her doctor was clear about the birth defects her medication could cause if she became pregnant but agreed to keep her on it as long as she had an IUD.
As she was waiting to get her contraceptive intrauterine device replaced at her local clinic, however, the billing nurse told her that her insurance wouldn’t cover the removal – or a new IUD. Chavarría didn’t understand why not.
“Then she said very delicately, ‘Well, people on this insurance typically tend to be older,’ ” Chavarría recalled.
Although Chavarría is 34, she is enrolled in Medicare, the government insurance program designed for those 65 and older. Chavarría, who lives in Houston, is disabled by fibromyalgia, rheumatoid arthritis, and mental health issues. Medicare automatically enrolls anyone who has received Social Security disability benefits for two years and this was her first time getting an IUD while in the government program.
Without insurance, just removing her expired IUD would cost Chavarría $350 out of pocket; exchanging it for a new one would be $2,000. She left the clinic in tears.
Chavarría’s experience is not rare. Medicare was originally intended for people of retirement age. Over the years, the program has evolved to include new populations, such as those who have disabilities or are critically ill, said Jennifer Lea Huer, a public health expert at Yale University, New Haven, Conn. In 2020, 1.7 million people ages 18-44 were enrolled in Medicare.
An estimated 70% of childbearing-age women on Medicare are also eligible for Medicaid, a state and federal program for those with low incomes, which should fill the gap for contraception. It’s not clear how many transgender or nonbinary people – who also might need contraception – are on Medicare or are eligible for Medicaid.
Medicaid, like the plans offered via the federal Affordable Care Act, mandates coverage of birth control. But those who aren’t eligible for Medicaid are left in the lurch – Medicare’s origins mean it does not require access to birth control.
Traditional Medicare includes two parts: Part A covers hospital costs, while Part B covers physicians’ care and certain other services, such as ambulance rides. Neither ordinarily includes contraception.
People can get contraception through a Medicare Advantage plan or Part D of Medicare, which covers prescription drugs, but those come at a cost. And even people who pay for Part D often aren’t covered for some types of birth control, such as IUDs.
“So, if you are disabled, if you are locked outside of the labor market, if you do not have the means or any other way to financially support yourself, you were likely still on traditional Medicare, which is Part A and Part B,” Huer said. “In which case, your access to contraception is incredibly difficult.”
Contraception for those with traditional Medicare is given on a case-by-case basis, Huer said. It can be covered only if a doctor can make a credible case that the patient needs it for medical reasons – because their body cannot sustain a pregnancy – as opposed to merely wanting to avoid one.
“You have to have a champion physician who’s willing to partner with you and make those arguments,” Huer said.
That’s what Chavarría’s doctor tried to do. Before she left the clinic, staffers there told her they would try to make the case she needed the IUD for medical reasons. The IUD exchange was scheduled almost 10 weeks later, but during those weeks, she got pregnant. Her body couldn’t sustain a pregnancy, so she and her partner rushed to get an abortion just before Texas tightened its rules Sept. 1, 2021.
“If Medicare had just covered the IUD removal or exchange to begin with, none of this would have happened,” Chavarría said. “It would have saved me having to make a really tough decision that I never thought I’d have to make.”
Women with disabilities often face a stigma from health care practitioners, especially when it comes to birth control, said Willi Horner-Johnson, a public health researcher specializing in disabilities at Oregon Health & Science University, Portland. In her research, women with disabilities have described being treated like children or having to go to multiple doctors to find someone with whom they felt comfortable.
“We don’t want to acknowledge that disabled people have sex,” said Miriam Garber, a 36-year-old sex worker who lives in Rhode Island and is also on Medicare because of her disabilities. Garber got an IUD from Planned Parenthood because her insurance wouldn’t cover it.
Even those who pay for Part D to have their prescription drugs covered and have a “champion physician” face difficulties. Liz Moore, a nonbinary person in their 30s who lives in the Washington, D.C., area, could not get Medicare to pay for the Mirena IUD their doctor prescribed for their polycystic ovary syndrome. Moore is disabled with fibromyalgia and dysautonomia, a condition of the autonomic nervous system, which regulates breathing, heart rate, and more.
“After literally months of phone calls, it seemed like my Medicare Part D and original Medicare could not agree on who should pay for my IUD,” they wrote in a direct message. “Was it a prescription or durable medical equipment?”
When Moore finally learned it would cost $800 upfront, they said, they decided to get a hysterectomy – which Medicare would pay for – instead.
Chavarría’s doctor told her a tubal ligation also was more likely to be approved by Medicare than an IUD, because older people have that procedure more often. Like all surgeries, both come with risks of complications and recovery.
Even for those on both Medicare and Medicaid, getting contraception also isn’t always easy, as in Katie Elizabeth Walsh’s case.
Walsh, 34, who lives in northeastern Connecticut, is disabled by a traumatic brain injury, depression, and chronic fatigue syndrome. She got an IUD at an ob.gyn. clinic and was told there her insurance would cover it.
Then she got a bill for nearly $2,000.
Medicaid should cover contraceptive devices for dual-eligibility people, according to Centers for Medicare & Medicaid Services policy guidance, but when Walsh tried to get her bill covered, Medicare and Medicaid could not agree on which of them should pay.
“Every single time I have called one of the insurance offices, they are like, ‘Oh, no, you have to talk to the other one, and we don’t really talk to each other,’ ” Walsh said.
Walsh said the hassle to get her contraception covered feels like a kick in the stomach: “Like truly you do not have a place in this world, and your insurance is telling you that.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.