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Hormonal contraceptive use linked to leukemia risk in offspring
A nationwide cohort study found an association between a woman’s use of hormonal contraceptives and a small increased risk of nonlymphoid leukemia in her offspring.
Maternal use of hormonal contraception either during pregnancy or in the 3 months beforehand was associated with a 46% higher risk of any leukemia in the children (P = .011), compared with no use, Marie Hargreave, PhD, of the Danish Cancer Society Research Center and her coauthors reported in Lancet Oncology.
The study of 1,185,157 children born between 1996 and 2014 included data from the Danish Cancer Registry and Danish National Prescription Registry and followed children for a median of 9.3 years.
Use during pregnancy was associated with a 78% higher risk of any leukemia in the offspring (P = .070), and contraception use that stopped more than 3 months before pregnancy was associated with a 25% higher risk of any leukemia (P = .039).
The researchers estimated that maternal use of hormonal contraceptives up to and including during pregnancy would have resulted in about one additional case of leukemia per 47,170 children; in other words, 25 additional cases of leukemia in Denmark from contraceptive use from 1996 to 2014.
The increased risk appeared to be limited to nonlymphoid leukemia only. The risk with recent use was more than twofold higher (HR, 2.17), compared with nonuse, and use during pregnancy was associated with a nearly fourfold increase in the risk of leukemia (HR, 3.87).
“Sex hormones are considered to be potent carcinogens, and the causal association between in-utero exposure to the oestrogen analogue diethylstilbestrol and subsequent risk for adenocarcinoma of the vagina is firmly established,” Dr. Hargreave and her colleagues wrote. “The mechanism by which maternal use of hormones increases cancer risk in children is, however, still not clear.”
Recent use of combined oral contraceptive products was associated with a more than twofold increased risk of nonlymphoid leukemia in offspring, compared with no use. However progestin-only oral contraceptives and emergency contraception did not appear to increase in the risk of lymphoid or nonlymphoid leukemia.
The association was strongest in children aged 6-10 years, which the authors suggested was likely because the incidence of nonlymphoid leukemia increases after the age of 6 years.
While acknowledging that the small increase in leukemia risk was not a major safety concern for hormonal contraceptives, the authors commented that the results suggested the intrauterine hormonal environment could be a direction for research into the causes of leukemia.
The study was supported by the Danish Cancer Research Foundation and other foundations. One author reported grants from the sponsoring foundations and another author reported speaking fees from Jazz Pharmaceuticals and Shire Pharmaceuticals.
SOURCE: Hargreave M et al. Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045(18)30479-0.
Estrogenic compounds could have a number of effects on the genomic machinery, that could in turn lead to an increased risk of leukemia in offspring. It may be that oral contraceptives cause epigenetic changes to fetal hematopoietic stem cells that lead to gene rearrangements and oxidative damage, which could then influence the risk of developing childhood leukemia.
This study opens a new avenue of investigation for a risk factor that might increase a child’s susceptibility to leukemia and is important in shedding more light on dose-response associations of exposures.
Dr. Maria S. Pombo-de-Oliveira is from the pediatric hematology-oncology research program at the Instituto Nacional de Câncer in Rio de Janeiro. These comments are adapted from an accompanying editorial (Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045[18]30509-6). Dr. Pombo-de-Oliveira reported having no conflicts of interest.
Estrogenic compounds could have a number of effects on the genomic machinery, that could in turn lead to an increased risk of leukemia in offspring. It may be that oral contraceptives cause epigenetic changes to fetal hematopoietic stem cells that lead to gene rearrangements and oxidative damage, which could then influence the risk of developing childhood leukemia.
This study opens a new avenue of investigation for a risk factor that might increase a child’s susceptibility to leukemia and is important in shedding more light on dose-response associations of exposures.
Dr. Maria S. Pombo-de-Oliveira is from the pediatric hematology-oncology research program at the Instituto Nacional de Câncer in Rio de Janeiro. These comments are adapted from an accompanying editorial (Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045[18]30509-6). Dr. Pombo-de-Oliveira reported having no conflicts of interest.
Estrogenic compounds could have a number of effects on the genomic machinery, that could in turn lead to an increased risk of leukemia in offspring. It may be that oral contraceptives cause epigenetic changes to fetal hematopoietic stem cells that lead to gene rearrangements and oxidative damage, which could then influence the risk of developing childhood leukemia.
This study opens a new avenue of investigation for a risk factor that might increase a child’s susceptibility to leukemia and is important in shedding more light on dose-response associations of exposures.
Dr. Maria S. Pombo-de-Oliveira is from the pediatric hematology-oncology research program at the Instituto Nacional de Câncer in Rio de Janeiro. These comments are adapted from an accompanying editorial (Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045[18]30509-6). Dr. Pombo-de-Oliveira reported having no conflicts of interest.
A nationwide cohort study found an association between a woman’s use of hormonal contraceptives and a small increased risk of nonlymphoid leukemia in her offspring.
Maternal use of hormonal contraception either during pregnancy or in the 3 months beforehand was associated with a 46% higher risk of any leukemia in the children (P = .011), compared with no use, Marie Hargreave, PhD, of the Danish Cancer Society Research Center and her coauthors reported in Lancet Oncology.
The study of 1,185,157 children born between 1996 and 2014 included data from the Danish Cancer Registry and Danish National Prescription Registry and followed children for a median of 9.3 years.
Use during pregnancy was associated with a 78% higher risk of any leukemia in the offspring (P = .070), and contraception use that stopped more than 3 months before pregnancy was associated with a 25% higher risk of any leukemia (P = .039).
The researchers estimated that maternal use of hormonal contraceptives up to and including during pregnancy would have resulted in about one additional case of leukemia per 47,170 children; in other words, 25 additional cases of leukemia in Denmark from contraceptive use from 1996 to 2014.
The increased risk appeared to be limited to nonlymphoid leukemia only. The risk with recent use was more than twofold higher (HR, 2.17), compared with nonuse, and use during pregnancy was associated with a nearly fourfold increase in the risk of leukemia (HR, 3.87).
“Sex hormones are considered to be potent carcinogens, and the causal association between in-utero exposure to the oestrogen analogue diethylstilbestrol and subsequent risk for adenocarcinoma of the vagina is firmly established,” Dr. Hargreave and her colleagues wrote. “The mechanism by which maternal use of hormones increases cancer risk in children is, however, still not clear.”
Recent use of combined oral contraceptive products was associated with a more than twofold increased risk of nonlymphoid leukemia in offspring, compared with no use. However progestin-only oral contraceptives and emergency contraception did not appear to increase in the risk of lymphoid or nonlymphoid leukemia.
The association was strongest in children aged 6-10 years, which the authors suggested was likely because the incidence of nonlymphoid leukemia increases after the age of 6 years.
While acknowledging that the small increase in leukemia risk was not a major safety concern for hormonal contraceptives, the authors commented that the results suggested the intrauterine hormonal environment could be a direction for research into the causes of leukemia.
The study was supported by the Danish Cancer Research Foundation and other foundations. One author reported grants from the sponsoring foundations and another author reported speaking fees from Jazz Pharmaceuticals and Shire Pharmaceuticals.
SOURCE: Hargreave M et al. Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045(18)30479-0.
A nationwide cohort study found an association between a woman’s use of hormonal contraceptives and a small increased risk of nonlymphoid leukemia in her offspring.
Maternal use of hormonal contraception either during pregnancy or in the 3 months beforehand was associated with a 46% higher risk of any leukemia in the children (P = .011), compared with no use, Marie Hargreave, PhD, of the Danish Cancer Society Research Center and her coauthors reported in Lancet Oncology.
The study of 1,185,157 children born between 1996 and 2014 included data from the Danish Cancer Registry and Danish National Prescription Registry and followed children for a median of 9.3 years.
Use during pregnancy was associated with a 78% higher risk of any leukemia in the offspring (P = .070), and contraception use that stopped more than 3 months before pregnancy was associated with a 25% higher risk of any leukemia (P = .039).
The researchers estimated that maternal use of hormonal contraceptives up to and including during pregnancy would have resulted in about one additional case of leukemia per 47,170 children; in other words, 25 additional cases of leukemia in Denmark from contraceptive use from 1996 to 2014.
The increased risk appeared to be limited to nonlymphoid leukemia only. The risk with recent use was more than twofold higher (HR, 2.17), compared with nonuse, and use during pregnancy was associated with a nearly fourfold increase in the risk of leukemia (HR, 3.87).
“Sex hormones are considered to be potent carcinogens, and the causal association between in-utero exposure to the oestrogen analogue diethylstilbestrol and subsequent risk for adenocarcinoma of the vagina is firmly established,” Dr. Hargreave and her colleagues wrote. “The mechanism by which maternal use of hormones increases cancer risk in children is, however, still not clear.”
Recent use of combined oral contraceptive products was associated with a more than twofold increased risk of nonlymphoid leukemia in offspring, compared with no use. However progestin-only oral contraceptives and emergency contraception did not appear to increase in the risk of lymphoid or nonlymphoid leukemia.
The association was strongest in children aged 6-10 years, which the authors suggested was likely because the incidence of nonlymphoid leukemia increases after the age of 6 years.
While acknowledging that the small increase in leukemia risk was not a major safety concern for hormonal contraceptives, the authors commented that the results suggested the intrauterine hormonal environment could be a direction for research into the causes of leukemia.
The study was supported by the Danish Cancer Research Foundation and other foundations. One author reported grants from the sponsoring foundations and another author reported speaking fees from Jazz Pharmaceuticals and Shire Pharmaceuticals.
SOURCE: Hargreave M et al. Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045(18)30479-0.
FROM LANCET ONCOLOGY
Key clinical point:
Major finding: Recent maternal hormonal contraceptive use was linked to one additional case of leukemia per 47,170 children.
Study details: Danish nationwide cohort study in 1,185,157 children.
Disclosures: The study was supported by the Danish Cancer Research Foundation and other foundations. One author reported grants from the sponsoring foundations and another author reported speaking fees from Jazz Pharmaceuticals and Shire Pharmaceuticals.
Source: Hargreave M et al. Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045(18)30479-0.
Children born from ART at increased risk of developing arterial hypertension
Children born from assisted reproductive technologies such as in vitro fertilization and intracytoplasmic sperm injection may be at risk of developing arterial hypertension due to premature vascular aging, according to a study published in the Journal of the American College of Cardiology.
In a previous study, Emrush Rexhaj, MD, director of arterial hypertension and altitude medicine at Inselspital, University Hospital, Bern, Switzerland, and his colleagues assessed vascular function in participants who were born with assisted reproductive technology (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI); the investigators found vascular dysfunction in this patient population not “related to parental factors but to the ART procedure itself,” they said.
Dr. Rexhaj and his colleagues then reassessed vascular function in 54 participants (mean age 16.5 years old) who returned from the previous study 5 years after the initial assessment and compared the results with 43 matched patients in a control group (mean age, 17.4 years). There were no significant differences regarding body mass index, lipid, creatinine, electrolyte plasma concentrations, high-sensitive C-reactive protein, birth weight, and gestational age between children in either group, as well as no significant differences in maternal BMI, cardiovascular risk profile, and smoking status.
The investigators – with Théo A. Meister, MD, also of the university, as a joint lead author with Dr. Rexhaj – performed blinded endothelium-dependent and endothelium-independent vasodilation of the brachial artery in a supine position at room temperature and after 15 minutes of rest. They also measured carotid intima-media thickness (IMT), large artery stiffness, 24-hour ambulatory blood pressure monitoring, and short-term blood pressure variability.
“It only took five years for differences in arterial blood pressure to show,” Dr. Rexhaj stated in a press release. “This is a rapidly growing population and apparently healthy children are showing serious signs of concern for early cardiovascular risk, especially when it comes to arterial hypertension.”
Specifically, there was an approximately 25% reduction in flow-mediated dilation in the ART group (7%) compared with the control group (9%), which the investigators attributed to endothelial dysfunction (P less than .001). In ART patients, carotid IMT (463 mm) and carotid pulse-wave velocity (7.7 m/s) was significantly increased, compared with carotid IMT (435 mm; P less than .01) and pulse-wave velocity (7.2 m/s; P equals .033) in the control group.
With regard to arterial hypertension, 24-hour systolic blood pressure in the ART group (120 mm Hg) was “markedly” higher than in the control group (116 mm Hg; P equals .02); 24-hour diastolic blood pressure was also significantly higher in the ART group (71 mm Hg) compared with the control group (69 mm Hg; P equals .03). Investigators noted 8 of the 52 patients (15%) in the ART group met clinical criteria for arterial hypertension according to ambulatory blood pressure monitoring, compared with 1 of the 40 patients (2%) in the control group.
“The increased prevalence of arterial hypertension in ART participants is what is most concerning,” Dr. Rexhaj stated in the release. “There is growing evidence that ART alters the blood vessels in children, but the long-term consequences were not known. We now know that this places ART children at a six times higher rate of hypertension than children conceived naturally.”
The investigators cited as a limitation the fact that they studied only children born from singleton births recruited from a single center, which may have a lower cardiovascular risk profile than other patient populations.
This study was supported by the Swiss National Science Foundation, the Placide Nicod Foundation, the Swiss Society of Hypertension, the Swiss Society of Cardiology and Mach-Gaensslen Stiftung (Schweiz). The authors reported no conflicts of interest.
SOURCE: Meister TA et al. J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.06.060.
Clinicians should be vigilant in detecting early cardiovascular problems in children born from ART, Larry A. Weinrauch, MD, of Harvard Medical School, Boston, and his colleagues wrote in a joint editorial comment. While the sixfold higher risk of arterial hypertension was obtained from an ambulatory blood pressure monitoring that was not repeated, the relative risk of cardiovascular problems for singleton births could be a sign that a greater risk for vascular aging exists with multiple births.
“This observation, derived from a relatively small cohort, may actually understate the importance of this problem for ART populations because higher risk populations for development of hypertension (e.g., multiple birth pregnancies) and those resulting from maternal factors of excess risk (e.g., eclampsia, chronic hypertension, diabetes, obesity) were excluded from the study,” Dr. Weinrauch and his colleagues said.
The authors cited the pediatric hypertension clinical practice guidelines of annual in-office hypertension screening after 3 years of age and noted that certain high-risk groups, such as patients with repaired aortic coarctation and chronic kidney disease, should be screened “at every health encounter.
“If adolescent hypertension risk is really sixfold higher in ART patients (and potentially subsequent generations), consequences for longevity will be vast given the millions of patients whose births were achieved by using ART methods,” wrote Dr. Weinrauch and his colleagues. “Early study, detection, and treatment of ART-conceived individuals may be the appropriate ounce of prevention.”
Dr. Weinrauch is with Harvard Medical School, Marie D. Gerhard-Herman, MD, is with Brigham and Women’s Hospital, and Michael M. Mendelson, MD, is with Boston Children’s Hospital, all in Boston. These comments summarize their editorial in response to Meister et al. (J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.07.013). Dr. Gerhard-Herman is supported by the Progeria Research Foundation and Dr. Mendelson is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. They reported no other relevant conflicts of interest.
Clinicians should be vigilant in detecting early cardiovascular problems in children born from ART, Larry A. Weinrauch, MD, of Harvard Medical School, Boston, and his colleagues wrote in a joint editorial comment. While the sixfold higher risk of arterial hypertension was obtained from an ambulatory blood pressure monitoring that was not repeated, the relative risk of cardiovascular problems for singleton births could be a sign that a greater risk for vascular aging exists with multiple births.
“This observation, derived from a relatively small cohort, may actually understate the importance of this problem for ART populations because higher risk populations for development of hypertension (e.g., multiple birth pregnancies) and those resulting from maternal factors of excess risk (e.g., eclampsia, chronic hypertension, diabetes, obesity) were excluded from the study,” Dr. Weinrauch and his colleagues said.
The authors cited the pediatric hypertension clinical practice guidelines of annual in-office hypertension screening after 3 years of age and noted that certain high-risk groups, such as patients with repaired aortic coarctation and chronic kidney disease, should be screened “at every health encounter.
“If adolescent hypertension risk is really sixfold higher in ART patients (and potentially subsequent generations), consequences for longevity will be vast given the millions of patients whose births were achieved by using ART methods,” wrote Dr. Weinrauch and his colleagues. “Early study, detection, and treatment of ART-conceived individuals may be the appropriate ounce of prevention.”
Dr. Weinrauch is with Harvard Medical School, Marie D. Gerhard-Herman, MD, is with Brigham and Women’s Hospital, and Michael M. Mendelson, MD, is with Boston Children’s Hospital, all in Boston. These comments summarize their editorial in response to Meister et al. (J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.07.013). Dr. Gerhard-Herman is supported by the Progeria Research Foundation and Dr. Mendelson is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. They reported no other relevant conflicts of interest.
Clinicians should be vigilant in detecting early cardiovascular problems in children born from ART, Larry A. Weinrauch, MD, of Harvard Medical School, Boston, and his colleagues wrote in a joint editorial comment. While the sixfold higher risk of arterial hypertension was obtained from an ambulatory blood pressure monitoring that was not repeated, the relative risk of cardiovascular problems for singleton births could be a sign that a greater risk for vascular aging exists with multiple births.
“This observation, derived from a relatively small cohort, may actually understate the importance of this problem for ART populations because higher risk populations for development of hypertension (e.g., multiple birth pregnancies) and those resulting from maternal factors of excess risk (e.g., eclampsia, chronic hypertension, diabetes, obesity) were excluded from the study,” Dr. Weinrauch and his colleagues said.
The authors cited the pediatric hypertension clinical practice guidelines of annual in-office hypertension screening after 3 years of age and noted that certain high-risk groups, such as patients with repaired aortic coarctation and chronic kidney disease, should be screened “at every health encounter.
“If adolescent hypertension risk is really sixfold higher in ART patients (and potentially subsequent generations), consequences for longevity will be vast given the millions of patients whose births were achieved by using ART methods,” wrote Dr. Weinrauch and his colleagues. “Early study, detection, and treatment of ART-conceived individuals may be the appropriate ounce of prevention.”
Dr. Weinrauch is with Harvard Medical School, Marie D. Gerhard-Herman, MD, is with Brigham and Women’s Hospital, and Michael M. Mendelson, MD, is with Boston Children’s Hospital, all in Boston. These comments summarize their editorial in response to Meister et al. (J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.07.013). Dr. Gerhard-Herman is supported by the Progeria Research Foundation and Dr. Mendelson is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. They reported no other relevant conflicts of interest.
Children born from assisted reproductive technologies such as in vitro fertilization and intracytoplasmic sperm injection may be at risk of developing arterial hypertension due to premature vascular aging, according to a study published in the Journal of the American College of Cardiology.
In a previous study, Emrush Rexhaj, MD, director of arterial hypertension and altitude medicine at Inselspital, University Hospital, Bern, Switzerland, and his colleagues assessed vascular function in participants who were born with assisted reproductive technology (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI); the investigators found vascular dysfunction in this patient population not “related to parental factors but to the ART procedure itself,” they said.
Dr. Rexhaj and his colleagues then reassessed vascular function in 54 participants (mean age 16.5 years old) who returned from the previous study 5 years after the initial assessment and compared the results with 43 matched patients in a control group (mean age, 17.4 years). There were no significant differences regarding body mass index, lipid, creatinine, electrolyte plasma concentrations, high-sensitive C-reactive protein, birth weight, and gestational age between children in either group, as well as no significant differences in maternal BMI, cardiovascular risk profile, and smoking status.
The investigators – with Théo A. Meister, MD, also of the university, as a joint lead author with Dr. Rexhaj – performed blinded endothelium-dependent and endothelium-independent vasodilation of the brachial artery in a supine position at room temperature and after 15 minutes of rest. They also measured carotid intima-media thickness (IMT), large artery stiffness, 24-hour ambulatory blood pressure monitoring, and short-term blood pressure variability.
“It only took five years for differences in arterial blood pressure to show,” Dr. Rexhaj stated in a press release. “This is a rapidly growing population and apparently healthy children are showing serious signs of concern for early cardiovascular risk, especially when it comes to arterial hypertension.”
Specifically, there was an approximately 25% reduction in flow-mediated dilation in the ART group (7%) compared with the control group (9%), which the investigators attributed to endothelial dysfunction (P less than .001). In ART patients, carotid IMT (463 mm) and carotid pulse-wave velocity (7.7 m/s) was significantly increased, compared with carotid IMT (435 mm; P less than .01) and pulse-wave velocity (7.2 m/s; P equals .033) in the control group.
With regard to arterial hypertension, 24-hour systolic blood pressure in the ART group (120 mm Hg) was “markedly” higher than in the control group (116 mm Hg; P equals .02); 24-hour diastolic blood pressure was also significantly higher in the ART group (71 mm Hg) compared with the control group (69 mm Hg; P equals .03). Investigators noted 8 of the 52 patients (15%) in the ART group met clinical criteria for arterial hypertension according to ambulatory blood pressure monitoring, compared with 1 of the 40 patients (2%) in the control group.
“The increased prevalence of arterial hypertension in ART participants is what is most concerning,” Dr. Rexhaj stated in the release. “There is growing evidence that ART alters the blood vessels in children, but the long-term consequences were not known. We now know that this places ART children at a six times higher rate of hypertension than children conceived naturally.”
The investigators cited as a limitation the fact that they studied only children born from singleton births recruited from a single center, which may have a lower cardiovascular risk profile than other patient populations.
This study was supported by the Swiss National Science Foundation, the Placide Nicod Foundation, the Swiss Society of Hypertension, the Swiss Society of Cardiology and Mach-Gaensslen Stiftung (Schweiz). The authors reported no conflicts of interest.
SOURCE: Meister TA et al. J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.06.060.
Children born from assisted reproductive technologies such as in vitro fertilization and intracytoplasmic sperm injection may be at risk of developing arterial hypertension due to premature vascular aging, according to a study published in the Journal of the American College of Cardiology.
In a previous study, Emrush Rexhaj, MD, director of arterial hypertension and altitude medicine at Inselspital, University Hospital, Bern, Switzerland, and his colleagues assessed vascular function in participants who were born with assisted reproductive technology (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI); the investigators found vascular dysfunction in this patient population not “related to parental factors but to the ART procedure itself,” they said.
Dr. Rexhaj and his colleagues then reassessed vascular function in 54 participants (mean age 16.5 years old) who returned from the previous study 5 years after the initial assessment and compared the results with 43 matched patients in a control group (mean age, 17.4 years). There were no significant differences regarding body mass index, lipid, creatinine, electrolyte plasma concentrations, high-sensitive C-reactive protein, birth weight, and gestational age between children in either group, as well as no significant differences in maternal BMI, cardiovascular risk profile, and smoking status.
The investigators – with Théo A. Meister, MD, also of the university, as a joint lead author with Dr. Rexhaj – performed blinded endothelium-dependent and endothelium-independent vasodilation of the brachial artery in a supine position at room temperature and after 15 minutes of rest. They also measured carotid intima-media thickness (IMT), large artery stiffness, 24-hour ambulatory blood pressure monitoring, and short-term blood pressure variability.
“It only took five years for differences in arterial blood pressure to show,” Dr. Rexhaj stated in a press release. “This is a rapidly growing population and apparently healthy children are showing serious signs of concern for early cardiovascular risk, especially when it comes to arterial hypertension.”
Specifically, there was an approximately 25% reduction in flow-mediated dilation in the ART group (7%) compared with the control group (9%), which the investigators attributed to endothelial dysfunction (P less than .001). In ART patients, carotid IMT (463 mm) and carotid pulse-wave velocity (7.7 m/s) was significantly increased, compared with carotid IMT (435 mm; P less than .01) and pulse-wave velocity (7.2 m/s; P equals .033) in the control group.
With regard to arterial hypertension, 24-hour systolic blood pressure in the ART group (120 mm Hg) was “markedly” higher than in the control group (116 mm Hg; P equals .02); 24-hour diastolic blood pressure was also significantly higher in the ART group (71 mm Hg) compared with the control group (69 mm Hg; P equals .03). Investigators noted 8 of the 52 patients (15%) in the ART group met clinical criteria for arterial hypertension according to ambulatory blood pressure monitoring, compared with 1 of the 40 patients (2%) in the control group.
“The increased prevalence of arterial hypertension in ART participants is what is most concerning,” Dr. Rexhaj stated in the release. “There is growing evidence that ART alters the blood vessels in children, but the long-term consequences were not known. We now know that this places ART children at a six times higher rate of hypertension than children conceived naturally.”
The investigators cited as a limitation the fact that they studied only children born from singleton births recruited from a single center, which may have a lower cardiovascular risk profile than other patient populations.
This study was supported by the Swiss National Science Foundation, the Placide Nicod Foundation, the Swiss Society of Hypertension, the Swiss Society of Cardiology and Mach-Gaensslen Stiftung (Schweiz). The authors reported no conflicts of interest.
SOURCE: Meister TA et al. J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.06.060.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point:
Major finding: In the ART group, 24-hour systolic blood pressure was significantly higher than in the control group (120 mm Hg vs. 116 mm Hg), and 24-hour diastolic blood pressure was also significantly higher in the ART group compared with the control group (71 mm Hg vs. 69 mm Hg).
Study details: A reassessment of 54 children born from ART.
Disclosures: This study was supported by the Swiss National Science Foundation, the Placide Nicod Foundation, the Swiss Society of Hypertension, the Swiss Society of Cardiology and Mach-Gaensslen Stiftung (Schweiz). The authors reported no conflicts of interest.
Source: Meister TA et al. J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.06.060.
FDA approves first mobile app for contraceptive use
The Food and Drug Administration has approved marketing of the first medical mobile application that can be used as a contraceptive, the agency announced in a written statement.
The app, called Natural Cycles, contains an algorithm that calculates the days of the month women are likely to be fertile, based on daily body temperature readings and menstrual cycle information, and is intended for premenopausal women aged 18 years and older. App users are instructed to take their daily body temperatures with a basal body thermometer and enter the information into the app. The more-sensitive basal body thermometer can detect temperature elevations during ovulation, and the app will display a warning on days when users are most fertile. During these days, women should either abstain from sex or use protection.
In clinical studies comprising more than 15,000 women, Natural Cycles had a “perfect use” failure rate of 1.8% and a “normal use” failure rate of 6.5%. This compares favorably with other forms of contraception and birth control: Male condoms have a perfect use failure rate of 2.0% and a normal use failure rate of 18.0%, and combined oral contraceptives have a perfect use failure rate of 0.3% and a normal use failure rate of 9.0%, according to the Association of Reproductive Care Professionals.
“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in the statement.
The app should not be used by women with a condition in which a pregnancy would present risk to the mother or fetus or by women who are using a birth control or hormonal treatment that inhibits ovulation. Natural Cycles does not protect against sexually transmitted infections.
The Food and Drug Administration has approved marketing of the first medical mobile application that can be used as a contraceptive, the agency announced in a written statement.
The app, called Natural Cycles, contains an algorithm that calculates the days of the month women are likely to be fertile, based on daily body temperature readings and menstrual cycle information, and is intended for premenopausal women aged 18 years and older. App users are instructed to take their daily body temperatures with a basal body thermometer and enter the information into the app. The more-sensitive basal body thermometer can detect temperature elevations during ovulation, and the app will display a warning on days when users are most fertile. During these days, women should either abstain from sex or use protection.
In clinical studies comprising more than 15,000 women, Natural Cycles had a “perfect use” failure rate of 1.8% and a “normal use” failure rate of 6.5%. This compares favorably with other forms of contraception and birth control: Male condoms have a perfect use failure rate of 2.0% and a normal use failure rate of 18.0%, and combined oral contraceptives have a perfect use failure rate of 0.3% and a normal use failure rate of 9.0%, according to the Association of Reproductive Care Professionals.
“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in the statement.
The app should not be used by women with a condition in which a pregnancy would present risk to the mother or fetus or by women who are using a birth control or hormonal treatment that inhibits ovulation. Natural Cycles does not protect against sexually transmitted infections.
The Food and Drug Administration has approved marketing of the first medical mobile application that can be used as a contraceptive, the agency announced in a written statement.
The app, called Natural Cycles, contains an algorithm that calculates the days of the month women are likely to be fertile, based on daily body temperature readings and menstrual cycle information, and is intended for premenopausal women aged 18 years and older. App users are instructed to take their daily body temperatures with a basal body thermometer and enter the information into the app. The more-sensitive basal body thermometer can detect temperature elevations during ovulation, and the app will display a warning on days when users are most fertile. During these days, women should either abstain from sex or use protection.
In clinical studies comprising more than 15,000 women, Natural Cycles had a “perfect use” failure rate of 1.8% and a “normal use” failure rate of 6.5%. This compares favorably with other forms of contraception and birth control: Male condoms have a perfect use failure rate of 2.0% and a normal use failure rate of 18.0%, and combined oral contraceptives have a perfect use failure rate of 0.3% and a normal use failure rate of 9.0%, according to the Association of Reproductive Care Professionals.
“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in the statement.
The app should not be used by women with a condition in which a pregnancy would present risk to the mother or fetus or by women who are using a birth control or hormonal treatment that inhibits ovulation. Natural Cycles does not protect against sexually transmitted infections.
IVF linked to slight increase in risk of some cancers
A large observational study from Great Britain paints a mixed picture of cancer risks associated with assisted reproduction technologies such as in vitro fertilization (IVF).
Among nearly 256,000 women who had assisted reproduction over a 2-decade period and were followed for more than 2.25 million person-years, there was no significant increase in risk of uterine cancers or invasive breast cancers.
However, these women were at slight but significantly increased risk for in situ breast cancers and invasive or borderline ovarian cancers, although the ovarian tumors may be related more to patient factors than to the assisted reproduction technology itself, reported Alastair Sutcliffe, MD, PhD, from University College London, and his colleagues.
“We were not able to distinguish between a genuine increase in risk of borderline ovarian tumors and other explanations including surveillance bias. Further investigation of this and longer follow-up is warranted to continue monitoring these important outcomes in this ever-growing population,” they wrote in BMJ.
Women who undergo IVF and related procedures are typically exposed to high levels of estradiol, luteinizing hormone, follicle-stimulating hormone, and multiple ovarian punctures, all of which are potentially carcinogenic, the authors noted.
Previous studies of cancer risk in women who undergo assisted reproduction treatment have had conflicting or inconsistent results and lacked information on potential confounders, they pointed out.
To get a better sense of the potential risks, the investigators looked at linked data from the United Kingdom’s Human Fertilization and Embryology Authority and national cancer registries. They identified a total of 255,786 women treated from 1991 through 2010. Total follow-up was for 2,257,789 person-years.
They found that, during an average 8.8 years of follow-up, women had no significant increase in risk of tumors of the uterine corpus, with 164 cancers observed vs. 146.9 expected, for a standardized incidence ratio (SIR) of 1.12 (95% confidence interval, 0.95-1.30).
Similarly, there was no significant increase in risk of either breast cancer overall (2,578 observed vs. 2,641.2 expected; SIR, 0.98; 95% CI, 0.94-1.01) or invasive breast cancer (2,272 observed vs. 2,371.4 expected; SIR, 0.96; 95% CI, 0.92-1.00).
As noted, however, there was an increased risk of in situ breast cancer with 291 vs. 253.5 cases, respectively, translating into a SIR of 1.15 (95% CI, 1.02-1.29), for an absolute excess risk (AER) of 1.7 cases per 100,000 person-years, associated with an increasing number of treatment cycles (P = .03).
Additionally, the women in the study had an increased risk of ovarian cancer with an observed incidence of 405 vs. 291.82 expected, for an SIR of 1.39 (95% CI, 1.26-1.53) and an AER of 5.0 cases per 100,000 person-years.
There was a significantly increased risk for both invasive tumors, with 264 cases vs. 188.1 expected, for an SIR of 1.40 (95% CI, 1.24-1.58) and an AER of 3.4 cases per 100,000 person-years, and borderline ovarian cancers, with 141 vs. 103.7, for an SIR of 1.36 (95% CI, 1.15-1.60) and an AER of 1.7 cases per 100,000 person-years.
Increased risks of ovarian tumors were limited to women with endometriosis, low parity, or both. This study found no increased risk of any ovarian tumor in women treated because of only male-factor or unexplained infertility.
Women who had previously given birth and did not have a diagnosis of endometriosis had no increase in risk for ovarian cancer. Instead, increased risk appeared to be limited to women with endometriosis, few or no births (low parity), or both.
The authors emphasized that ongoing monitoring of outcomes for women who have undergone assisted reproduction is essential.
The study was funded by Cancer Research UK and the National Institute for Health Research, and supported by the NIHR Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London. Three authors reported personal fees or royalties from entities not involved in the study.
SOURCE: Williams CL et al. BMJ. 2018;362:k2644.
A large observational study from Great Britain paints a mixed picture of cancer risks associated with assisted reproduction technologies such as in vitro fertilization (IVF).
Among nearly 256,000 women who had assisted reproduction over a 2-decade period and were followed for more than 2.25 million person-years, there was no significant increase in risk of uterine cancers or invasive breast cancers.
However, these women were at slight but significantly increased risk for in situ breast cancers and invasive or borderline ovarian cancers, although the ovarian tumors may be related more to patient factors than to the assisted reproduction technology itself, reported Alastair Sutcliffe, MD, PhD, from University College London, and his colleagues.
“We were not able to distinguish between a genuine increase in risk of borderline ovarian tumors and other explanations including surveillance bias. Further investigation of this and longer follow-up is warranted to continue monitoring these important outcomes in this ever-growing population,” they wrote in BMJ.
Women who undergo IVF and related procedures are typically exposed to high levels of estradiol, luteinizing hormone, follicle-stimulating hormone, and multiple ovarian punctures, all of which are potentially carcinogenic, the authors noted.
Previous studies of cancer risk in women who undergo assisted reproduction treatment have had conflicting or inconsistent results and lacked information on potential confounders, they pointed out.
To get a better sense of the potential risks, the investigators looked at linked data from the United Kingdom’s Human Fertilization and Embryology Authority and national cancer registries. They identified a total of 255,786 women treated from 1991 through 2010. Total follow-up was for 2,257,789 person-years.
They found that, during an average 8.8 years of follow-up, women had no significant increase in risk of tumors of the uterine corpus, with 164 cancers observed vs. 146.9 expected, for a standardized incidence ratio (SIR) of 1.12 (95% confidence interval, 0.95-1.30).
Similarly, there was no significant increase in risk of either breast cancer overall (2,578 observed vs. 2,641.2 expected; SIR, 0.98; 95% CI, 0.94-1.01) or invasive breast cancer (2,272 observed vs. 2,371.4 expected; SIR, 0.96; 95% CI, 0.92-1.00).
As noted, however, there was an increased risk of in situ breast cancer with 291 vs. 253.5 cases, respectively, translating into a SIR of 1.15 (95% CI, 1.02-1.29), for an absolute excess risk (AER) of 1.7 cases per 100,000 person-years, associated with an increasing number of treatment cycles (P = .03).
Additionally, the women in the study had an increased risk of ovarian cancer with an observed incidence of 405 vs. 291.82 expected, for an SIR of 1.39 (95% CI, 1.26-1.53) and an AER of 5.0 cases per 100,000 person-years.
There was a significantly increased risk for both invasive tumors, with 264 cases vs. 188.1 expected, for an SIR of 1.40 (95% CI, 1.24-1.58) and an AER of 3.4 cases per 100,000 person-years, and borderline ovarian cancers, with 141 vs. 103.7, for an SIR of 1.36 (95% CI, 1.15-1.60) and an AER of 1.7 cases per 100,000 person-years.
Increased risks of ovarian tumors were limited to women with endometriosis, low parity, or both. This study found no increased risk of any ovarian tumor in women treated because of only male-factor or unexplained infertility.
Women who had previously given birth and did not have a diagnosis of endometriosis had no increase in risk for ovarian cancer. Instead, increased risk appeared to be limited to women with endometriosis, few or no births (low parity), or both.
The authors emphasized that ongoing monitoring of outcomes for women who have undergone assisted reproduction is essential.
The study was funded by Cancer Research UK and the National Institute for Health Research, and supported by the NIHR Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London. Three authors reported personal fees or royalties from entities not involved in the study.
SOURCE: Williams CL et al. BMJ. 2018;362:k2644.
A large observational study from Great Britain paints a mixed picture of cancer risks associated with assisted reproduction technologies such as in vitro fertilization (IVF).
Among nearly 256,000 women who had assisted reproduction over a 2-decade period and were followed for more than 2.25 million person-years, there was no significant increase in risk of uterine cancers or invasive breast cancers.
However, these women were at slight but significantly increased risk for in situ breast cancers and invasive or borderline ovarian cancers, although the ovarian tumors may be related more to patient factors than to the assisted reproduction technology itself, reported Alastair Sutcliffe, MD, PhD, from University College London, and his colleagues.
“We were not able to distinguish between a genuine increase in risk of borderline ovarian tumors and other explanations including surveillance bias. Further investigation of this and longer follow-up is warranted to continue monitoring these important outcomes in this ever-growing population,” they wrote in BMJ.
Women who undergo IVF and related procedures are typically exposed to high levels of estradiol, luteinizing hormone, follicle-stimulating hormone, and multiple ovarian punctures, all of which are potentially carcinogenic, the authors noted.
Previous studies of cancer risk in women who undergo assisted reproduction treatment have had conflicting or inconsistent results and lacked information on potential confounders, they pointed out.
To get a better sense of the potential risks, the investigators looked at linked data from the United Kingdom’s Human Fertilization and Embryology Authority and national cancer registries. They identified a total of 255,786 women treated from 1991 through 2010. Total follow-up was for 2,257,789 person-years.
They found that, during an average 8.8 years of follow-up, women had no significant increase in risk of tumors of the uterine corpus, with 164 cancers observed vs. 146.9 expected, for a standardized incidence ratio (SIR) of 1.12 (95% confidence interval, 0.95-1.30).
Similarly, there was no significant increase in risk of either breast cancer overall (2,578 observed vs. 2,641.2 expected; SIR, 0.98; 95% CI, 0.94-1.01) or invasive breast cancer (2,272 observed vs. 2,371.4 expected; SIR, 0.96; 95% CI, 0.92-1.00).
As noted, however, there was an increased risk of in situ breast cancer with 291 vs. 253.5 cases, respectively, translating into a SIR of 1.15 (95% CI, 1.02-1.29), for an absolute excess risk (AER) of 1.7 cases per 100,000 person-years, associated with an increasing number of treatment cycles (P = .03).
Additionally, the women in the study had an increased risk of ovarian cancer with an observed incidence of 405 vs. 291.82 expected, for an SIR of 1.39 (95% CI, 1.26-1.53) and an AER of 5.0 cases per 100,000 person-years.
There was a significantly increased risk for both invasive tumors, with 264 cases vs. 188.1 expected, for an SIR of 1.40 (95% CI, 1.24-1.58) and an AER of 3.4 cases per 100,000 person-years, and borderline ovarian cancers, with 141 vs. 103.7, for an SIR of 1.36 (95% CI, 1.15-1.60) and an AER of 1.7 cases per 100,000 person-years.
Increased risks of ovarian tumors were limited to women with endometriosis, low parity, or both. This study found no increased risk of any ovarian tumor in women treated because of only male-factor or unexplained infertility.
Women who had previously given birth and did not have a diagnosis of endometriosis had no increase in risk for ovarian cancer. Instead, increased risk appeared to be limited to women with endometriosis, few or no births (low parity), or both.
The authors emphasized that ongoing monitoring of outcomes for women who have undergone assisted reproduction is essential.
The study was funded by Cancer Research UK and the National Institute for Health Research, and supported by the NIHR Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London. Three authors reported personal fees or royalties from entities not involved in the study.
SOURCE: Williams CL et al. BMJ. 2018;362:k2644.
FROM BMJ
Key clinical point: Assisted reproductive technologies may be linked to increased risk for in situ breast and ovarian cancers.
Major finding: The standardized incidence ratios (observed vs. expected cases) for invasive and borderline ovarian tumors were 1.40 and 1.41, respectively, both statistically significant.
Study details: Observational study with linked fertility clinic and cancer registry data on 255,786 women with total follow-up of 2,257,789 person-years.
Disclosures: The study was funded by Cancer Research UK and the National Institute for Health Research, and supported by the NIHR Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London. Three authors reported personal fees or royalties from entities not involved in the study.
Source: Williams CL et al. BMJ. 2018;362:k2644.
Treat chronic endometritis to improve implantation rates
In a meta-analysis of five studies of chronic endometritis (CE), women cured of the condition had significantly higher rates of pregnancies, live births, and successful implantations compared with women who had persistent CE.
“These findings potentially suggest that CE is a reversible factor of infertility, whose recognition and therapy may provide better chances at subsequent [in vitro fertilization] attempts,” wrote Amerigo Vitagliano, MD, of the University of Padua (Italy), and his coauthors.
They sought to examine the effect of CE treatment on implantation for women with recurrent implantation failure. While CE is correlated with infertility, prior studies have not resolved the question of whether curing CE would restore fertility. The condition is cured in as many of 80% of cases with a single cycle of antibiotics. 
The systematic review found five studies with a total of 796 patients with recurrent implantation failure in Argentina, China, Italy, Japan, and the United States. Two studies compared cured CE with persistent CE, and three studies compared cured CE with patients not affected by CE.
Only one of the studies evaluated CE patients receiving antibiotics with CE patients not receiving antibiotics. The study showed that there was no difference between those two groups in clinical pregnancy rate, ongoing (12 or more weeks’ gestation) pregnancy rate/live birth rate, or implantation rate.
The significant result was the difference between cured and persistent CE. Those numbers worked out to a higher ongoing pregnancy rate/live birth rate (odds ratio, 6.81; 95% confidence interval, 2.08-22.24; P = .001), clinical pregnancy rate (OR, 4.98; 95% CI, 1.72-14.43; P = .003), and implantation rate (OR, 3.24; 95% CI, 1.33-7.88; P = .01), with no difference in the miscarriage rate (P = .30).
The authors recommend further research in the form of randomized controlled trials to confirm whether completed CE treatment will improve in vitro fertilization success, and whether routine CE screening is advisable for all patients with recurrent implantation failure. At present, they recommend that diagnosed cases of CE be resolved before continuing with fertility treatment.
“If our results are confirmed, CE may represent a new therapeutic target for women suffering from [recurrent implantation failure], with affordable access (diagnosed through a simple endometrial biopsy and treated by oral antibiotics),” they wrote.
The authors reported having no financial disclosures.
SOURCE: Vitagliano A et al. Fertil Steril. 2018 Jun. doi: 10.1016/j.fertnstert.2018.03.017.
In a meta-analysis of five studies of chronic endometritis (CE), women cured of the condition had significantly higher rates of pregnancies, live births, and successful implantations compared with women who had persistent CE.
“These findings potentially suggest that CE is a reversible factor of infertility, whose recognition and therapy may provide better chances at subsequent [in vitro fertilization] attempts,” wrote Amerigo Vitagliano, MD, of the University of Padua (Italy), and his coauthors.
They sought to examine the effect of CE treatment on implantation for women with recurrent implantation failure. While CE is correlated with infertility, prior studies have not resolved the question of whether curing CE would restore fertility. The condition is cured in as many of 80% of cases with a single cycle of antibiotics.
The systematic review found five studies with a total of 796 patients with recurrent implantation failure in Argentina, China, Italy, Japan, and the United States. Two studies compared cured CE with persistent CE, and three studies compared cured CE with patients not affected by CE.
Only one of the studies evaluated CE patients receiving antibiotics with CE patients not receiving antibiotics. The study showed that there was no difference between those two groups in clinical pregnancy rate, ongoing (12 or more weeks’ gestation) pregnancy rate/live birth rate, or implantation rate.
The significant result was the difference between cured and persistent CE. Those numbers worked out to a higher ongoing pregnancy rate/live birth rate (odds ratio, 6.81; 95% confidence interval, 2.08-22.24; P = .001), clinical pregnancy rate (OR, 4.98; 95% CI, 1.72-14.43; P = .003), and implantation rate (OR, 3.24; 95% CI, 1.33-7.88; P = .01), with no difference in the miscarriage rate (P = .30).
The authors recommend further research in the form of randomized controlled trials to confirm whether completed CE treatment will improve in vitro fertilization success, and whether routine CE screening is advisable for all patients with recurrent implantation failure. At present, they recommend that diagnosed cases of CE be resolved before continuing with fertility treatment.
“If our results are confirmed, CE may represent a new therapeutic target for women suffering from [recurrent implantation failure], with affordable access (diagnosed through a simple endometrial biopsy and treated by oral antibiotics),” they wrote.
The authors reported having no financial disclosures.
SOURCE: Vitagliano A et al. Fertil Steril. 2018 Jun. doi: 10.1016/j.fertnstert.2018.03.017.
In a meta-analysis of five studies of chronic endometritis (CE), women cured of the condition had significantly higher rates of pregnancies, live births, and successful implantations compared with women who had persistent CE.
“These findings potentially suggest that CE is a reversible factor of infertility, whose recognition and therapy may provide better chances at subsequent [in vitro fertilization] attempts,” wrote Amerigo Vitagliano, MD, of the University of Padua (Italy), and his coauthors.
They sought to examine the effect of CE treatment on implantation for women with recurrent implantation failure. While CE is correlated with infertility, prior studies have not resolved the question of whether curing CE would restore fertility. The condition is cured in as many of 80% of cases with a single cycle of antibiotics.
The systematic review found five studies with a total of 796 patients with recurrent implantation failure in Argentina, China, Italy, Japan, and the United States. Two studies compared cured CE with persistent CE, and three studies compared cured CE with patients not affected by CE.
Only one of the studies evaluated CE patients receiving antibiotics with CE patients not receiving antibiotics. The study showed that there was no difference between those two groups in clinical pregnancy rate, ongoing (12 or more weeks’ gestation) pregnancy rate/live birth rate, or implantation rate.
The significant result was the difference between cured and persistent CE. Those numbers worked out to a higher ongoing pregnancy rate/live birth rate (odds ratio, 6.81; 95% confidence interval, 2.08-22.24; P = .001), clinical pregnancy rate (OR, 4.98; 95% CI, 1.72-14.43; P = .003), and implantation rate (OR, 3.24; 95% CI, 1.33-7.88; P = .01), with no difference in the miscarriage rate (P = .30).
The authors recommend further research in the form of randomized controlled trials to confirm whether completed CE treatment will improve in vitro fertilization success, and whether routine CE screening is advisable for all patients with recurrent implantation failure. At present, they recommend that diagnosed cases of CE be resolved before continuing with fertility treatment.
“If our results are confirmed, CE may represent a new therapeutic target for women suffering from [recurrent implantation failure], with affordable access (diagnosed through a simple endometrial biopsy and treated by oral antibiotics),” they wrote.
The authors reported having no financial disclosures.
SOURCE: Vitagliano A et al. Fertil Steril. 2018 Jun. doi: 10.1016/j.fertnstert.2018.03.017.
FROM FERTILITY & STERILITY
Risk of adverse birth outcomes for singleton infants born to ART-treated or subfertile women
Singleton infants born to mothers who are subfertile or treated with assisted reproductive technology (ART) are at higher risk for multiple adverse health outcomes beyond prematurity, a recent retrospective study shows.
Risks of chromosomal abnormalities, infectious diseases, and cardiovascular and respiratory conditions were all increased, compared with infants born to fertile mothers, in analyses of neonatal outcomes stratified by gestational age.
This population-based study is among the first to show differences in adverse birth outcomes beyond preterm birth and, more specifically, by organ system conditions across gestational age categories, according to Sunah S. Hwang, MD, MPH, of the University of Colorado at Denver, Aurora, and her coinvestigators.
“With this approach, we offer more detailed associations between maternal fertility and the receipt of treatment along the continuum of fetal organ development and subsequent infant health conditions,” Dr. Hwang and her coauthors wrote in Pediatrics.
The study, which included singleton infants of at least 23 weeks’ gestational age born during 2004-2010, was based on data from a Massachusetts clinical ART database (MOSART) that was linked with state vital records.
Out of 350,123 infants with birth hospitalization records in the study cohort, 336,705 were born to fertile women, while 8,375 were born to women treated with ART, and 5,403 were born to subfertile women.
After adjustment for key maternal and infant characteristics, infants born to subfertile or ART-treated women were more often preterm as compared with infants to fertile mothers. Adjusted odds ratios were 1.39 (95% confidence interval, 1.26-1.54) and 1.72 (95% CI, 1.60-1.85) for infants of subfertile and ART-treated women, respectively, Dr. Hwang and her coinvestigators reported.
Infants born to subfertile or ART-treated women were also more likely to have adverse respiratory, gastrointestinal, or nutritional outcomes, with adjusted ORs ranging from 1.12 to 1.18, they added in the report.
Looking specifically at outcomes stratified by gestational age, they found an increased risk of congenital malformations, infectious diseases, and cardiovascular or respiratory outcomes, with adjusted ORs from 1.30 to 2.61, in the data published in the journal.
By contrast, there were no differences in risks of neonatal mortality, length of hospitalization, low birth weight, or neurologic and hematologic abnormalities for infants of subfertile and ART-treated women, compared with fertile women, according to Dr. Hwang and her coauthors.
These results confirm results of some previous studies that suggested a higher risk of adverse birth outcomes among infants born as singletons, according to the study authors.
“Although it is clearly accepted that multiple gestation is a significant predictor of preterm birth and low birth weight, recent studies have also revealed that, even among singleton births, mothers with infertility without ART treatment along with those who do undergo ART treatment are at higher risk for preterm delivery,” they wrote.
The study was funded by a grant from the National Institutes of Health. Authors said they had no financial relationships relevant to the study.
SOURCE: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.
Singleton infants born to mothers who are subfertile or treated with assisted reproductive technology (ART) are at higher risk for multiple adverse health outcomes beyond prematurity, a recent retrospective study shows.
Risks of chromosomal abnormalities, infectious diseases, and cardiovascular and respiratory conditions were all increased, compared with infants born to fertile mothers, in analyses of neonatal outcomes stratified by gestational age.
This population-based study is among the first to show differences in adverse birth outcomes beyond preterm birth and, more specifically, by organ system conditions across gestational age categories, according to Sunah S. Hwang, MD, MPH, of the University of Colorado at Denver, Aurora, and her coinvestigators.
“With this approach, we offer more detailed associations between maternal fertility and the receipt of treatment along the continuum of fetal organ development and subsequent infant health conditions,” Dr. Hwang and her coauthors wrote in Pediatrics.
The study, which included singleton infants of at least 23 weeks’ gestational age born during 2004-2010, was based on data from a Massachusetts clinical ART database (MOSART) that was linked with state vital records.
Out of 350,123 infants with birth hospitalization records in the study cohort, 336,705 were born to fertile women, while 8,375 were born to women treated with ART, and 5,403 were born to subfertile women.
After adjustment for key maternal and infant characteristics, infants born to subfertile or ART-treated women were more often preterm as compared with infants to fertile mothers. Adjusted odds ratios were 1.39 (95% confidence interval, 1.26-1.54) and 1.72 (95% CI, 1.60-1.85) for infants of subfertile and ART-treated women, respectively, Dr. Hwang and her coinvestigators reported.
Infants born to subfertile or ART-treated women were also more likely to have adverse respiratory, gastrointestinal, or nutritional outcomes, with adjusted ORs ranging from 1.12 to 1.18, they added in the report.
Looking specifically at outcomes stratified by gestational age, they found an increased risk of congenital malformations, infectious diseases, and cardiovascular or respiratory outcomes, with adjusted ORs from 1.30 to 2.61, in the data published in the journal.
By contrast, there were no differences in risks of neonatal mortality, length of hospitalization, low birth weight, or neurologic and hematologic abnormalities for infants of subfertile and ART-treated women, compared with fertile women, according to Dr. Hwang and her coauthors.
These results confirm results of some previous studies that suggested a higher risk of adverse birth outcomes among infants born as singletons, according to the study authors.
“Although it is clearly accepted that multiple gestation is a significant predictor of preterm birth and low birth weight, recent studies have also revealed that, even among singleton births, mothers with infertility without ART treatment along with those who do undergo ART treatment are at higher risk for preterm delivery,” they wrote.
The study was funded by a grant from the National Institutes of Health. Authors said they had no financial relationships relevant to the study.
SOURCE: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.
Singleton infants born to mothers who are subfertile or treated with assisted reproductive technology (ART) are at higher risk for multiple adverse health outcomes beyond prematurity, a recent retrospective study shows.
Risks of chromosomal abnormalities, infectious diseases, and cardiovascular and respiratory conditions were all increased, compared with infants born to fertile mothers, in analyses of neonatal outcomes stratified by gestational age.
This population-based study is among the first to show differences in adverse birth outcomes beyond preterm birth and, more specifically, by organ system conditions across gestational age categories, according to Sunah S. Hwang, MD, MPH, of the University of Colorado at Denver, Aurora, and her coinvestigators.
“With this approach, we offer more detailed associations between maternal fertility and the receipt of treatment along the continuum of fetal organ development and subsequent infant health conditions,” Dr. Hwang and her coauthors wrote in Pediatrics.
The study, which included singleton infants of at least 23 weeks’ gestational age born during 2004-2010, was based on data from a Massachusetts clinical ART database (MOSART) that was linked with state vital records.
Out of 350,123 infants with birth hospitalization records in the study cohort, 336,705 were born to fertile women, while 8,375 were born to women treated with ART, and 5,403 were born to subfertile women.
After adjustment for key maternal and infant characteristics, infants born to subfertile or ART-treated women were more often preterm as compared with infants to fertile mothers. Adjusted odds ratios were 1.39 (95% confidence interval, 1.26-1.54) and 1.72 (95% CI, 1.60-1.85) for infants of subfertile and ART-treated women, respectively, Dr. Hwang and her coinvestigators reported.
Infants born to subfertile or ART-treated women were also more likely to have adverse respiratory, gastrointestinal, or nutritional outcomes, with adjusted ORs ranging from 1.12 to 1.18, they added in the report.
Looking specifically at outcomes stratified by gestational age, they found an increased risk of congenital malformations, infectious diseases, and cardiovascular or respiratory outcomes, with adjusted ORs from 1.30 to 2.61, in the data published in the journal.
By contrast, there were no differences in risks of neonatal mortality, length of hospitalization, low birth weight, or neurologic and hematologic abnormalities for infants of subfertile and ART-treated women, compared with fertile women, according to Dr. Hwang and her coauthors.
These results confirm results of some previous studies that suggested a higher risk of adverse birth outcomes among infants born as singletons, according to the study authors.
“Although it is clearly accepted that multiple gestation is a significant predictor of preterm birth and low birth weight, recent studies have also revealed that, even among singleton births, mothers with infertility without ART treatment along with those who do undergo ART treatment are at higher risk for preterm delivery,” they wrote.
The study was funded by a grant from the National Institutes of Health. Authors said they had no financial relationships relevant to the study.
SOURCE: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.
FROM PEDIATRICS
Key clinical point: Subfertility, whether treated by ART or not, is associated with adverse health outcomes for infants.
Major finding: Infants of subfertile and ART-treated women were more likely to be born preterm (odds ratios, 1.39 and 1.72, respectively) than were the infants of fertile women.
Study details: Population-based study of 350,123 infants from a Massachusetts clinical database.
Disclosures: The study was funded by a grant from the National Institutes of Health. The authors said they had no financial relationships relevant to the study.
Source: Hwang SS et al. Pediatrics. 2018 Aug;142(2):e20174069.
Thyroid markers linked to risk of gestational diabetes
Thyroid dysfunction early in pregnancy may increase risk of gestational diabetes, results of a longitudinal study suggest.
Increased levels of free triiodothyronine (fT3) and the ratio of fT3 to free thyroxine (fT4) were associated with increased risk of this common metabolic complication of pregnancy, study authors reported in the Journal of Clinical Endocrinology & Metabolism.
“To our knowledge, this is the first study to identify fT3 and the fT3:fT4 ratio measured early in pregnancy as independent risk factors of gestational diabetes,” wrote Shristi Rawal, PhD, of the National Institute of Child Health and Human Development (NICHD) , and her colleagues.
Although routine thyroid function screening during pregnancy remains controversial, Dr. Rawal and colleagues said their results support the “potential benefits” of the practice, particularly in light of other recent evidence suggesting thyroid-related adverse pregnancy outcomes.
The current case control study by Dr. Rawal and her coinvestigators included 107 women with gestational diabetes and 214 nongestational diabetes controls selected from a 12-center pregnancy cohort, which included 2,802 women aged between 18 and 40 years. The thyroid markers fT3, fT4, and thyroid-stimulating hormone (TSH) were measured at four pregnancy visits, including first trimester (weeks 10-14) and second trimester (weeks 15-26).
The fT3:fT4 ratio had the strongest association with gestational diabetes. In the second trimester measurement, women in the highest quartile had an almost 14-fold increase in risk when compared to the lowest quartile, after adjusting for potential confounders including prepregnancy body mass index and diabetes family history (adjusted odds ratio, 13.60; 95% confidence interval, 3.97-46.30), Dr. Rawal and her colleagues reported. The ratio of fT3:fT4 at the first trimester was also associated with increased risk (aOR, 8.63; 95% CI, 2.87-26.00).
Similarly, fT3 was positively associated with gestational diabetes at the first trimester (aOR, 4.25; 95% CI, 1.67-10.80) and second trimester (aOR, 3.89; 95% CI, 1.50-10.10), investigators reported.
By contrast, there was no association between fT4 or TSH and gestational diabetes, they found.
“These findings, in combination with previous evidence of thyroid-related adverse pregnancy outcomes, support the benefits of thyroid screening among pregnant women in early to mid pregnancy,” senior author Cuilin Zhang, MD, MPH, PhD, of the NICHD, said in a press statement.
Thyroid function abnormalities are relatively common in pregnant women and have been associated with obstetric complications such as pregnancy loss and premature delivery, investigators noted.
Previous evidence is sparse regarding a potential link between thyroid dysfunction and gestational diabetes. There are some prospective studies that show women with hypothyroidism have an increased incidence of gestational diabetes, Dr. Rawal and her colleagues wrote. Isolated hypothyroxinema, or normal TSH and low fT4, has also been linked to increased risk in some studies, but not in others, they added.
Support for the study came from NICHD and the American Recovery and Reinvestment Act research grants. The authors reported no conflicts of interest.
SOURCE: Rawal S et al. J Clin Endocrinol Metab. 2018 Jun 7. doi: 10.1210/jc.2017-024421.
Thyroid dysfunction early in pregnancy may increase risk of gestational diabetes, results of a longitudinal study suggest.
Increased levels of free triiodothyronine (fT3) and the ratio of fT3 to free thyroxine (fT4) were associated with increased risk of this common metabolic complication of pregnancy, study authors reported in the Journal of Clinical Endocrinology & Metabolism.
“To our knowledge, this is the first study to identify fT3 and the fT3:fT4 ratio measured early in pregnancy as independent risk factors of gestational diabetes,” wrote Shristi Rawal, PhD, of the National Institute of Child Health and Human Development (NICHD) , and her colleagues.
Although routine thyroid function screening during pregnancy remains controversial, Dr. Rawal and colleagues said their results support the “potential benefits” of the practice, particularly in light of other recent evidence suggesting thyroid-related adverse pregnancy outcomes.
The current case control study by Dr. Rawal and her coinvestigators included 107 women with gestational diabetes and 214 nongestational diabetes controls selected from a 12-center pregnancy cohort, which included 2,802 women aged between 18 and 40 years. The thyroid markers fT3, fT4, and thyroid-stimulating hormone (TSH) were measured at four pregnancy visits, including first trimester (weeks 10-14) and second trimester (weeks 15-26).
The fT3:fT4 ratio had the strongest association with gestational diabetes. In the second trimester measurement, women in the highest quartile had an almost 14-fold increase in risk when compared to the lowest quartile, after adjusting for potential confounders including prepregnancy body mass index and diabetes family history (adjusted odds ratio, 13.60; 95% confidence interval, 3.97-46.30), Dr. Rawal and her colleagues reported. The ratio of fT3:fT4 at the first trimester was also associated with increased risk (aOR, 8.63; 95% CI, 2.87-26.00).
Similarly, fT3 was positively associated with gestational diabetes at the first trimester (aOR, 4.25; 95% CI, 1.67-10.80) and second trimester (aOR, 3.89; 95% CI, 1.50-10.10), investigators reported.
By contrast, there was no association between fT4 or TSH and gestational diabetes, they found.
“These findings, in combination with previous evidence of thyroid-related adverse pregnancy outcomes, support the benefits of thyroid screening among pregnant women in early to mid pregnancy,” senior author Cuilin Zhang, MD, MPH, PhD, of the NICHD, said in a press statement.
Thyroid function abnormalities are relatively common in pregnant women and have been associated with obstetric complications such as pregnancy loss and premature delivery, investigators noted.
Previous evidence is sparse regarding a potential link between thyroid dysfunction and gestational diabetes. There are some prospective studies that show women with hypothyroidism have an increased incidence of gestational diabetes, Dr. Rawal and her colleagues wrote. Isolated hypothyroxinema, or normal TSH and low fT4, has also been linked to increased risk in some studies, but not in others, they added.
Support for the study came from NICHD and the American Recovery and Reinvestment Act research grants. The authors reported no conflicts of interest.
SOURCE: Rawal S et al. J Clin Endocrinol Metab. 2018 Jun 7. doi: 10.1210/jc.2017-024421.
Thyroid dysfunction early in pregnancy may increase risk of gestational diabetes, results of a longitudinal study suggest.
Increased levels of free triiodothyronine (fT3) and the ratio of fT3 to free thyroxine (fT4) were associated with increased risk of this common metabolic complication of pregnancy, study authors reported in the Journal of Clinical Endocrinology & Metabolism.
“To our knowledge, this is the first study to identify fT3 and the fT3:fT4 ratio measured early in pregnancy as independent risk factors of gestational diabetes,” wrote Shristi Rawal, PhD, of the National Institute of Child Health and Human Development (NICHD) , and her colleagues.
Although routine thyroid function screening during pregnancy remains controversial, Dr. Rawal and colleagues said their results support the “potential benefits” of the practice, particularly in light of other recent evidence suggesting thyroid-related adverse pregnancy outcomes.
The current case control study by Dr. Rawal and her coinvestigators included 107 women with gestational diabetes and 214 nongestational diabetes controls selected from a 12-center pregnancy cohort, which included 2,802 women aged between 18 and 40 years. The thyroid markers fT3, fT4, and thyroid-stimulating hormone (TSH) were measured at four pregnancy visits, including first trimester (weeks 10-14) and second trimester (weeks 15-26).
The fT3:fT4 ratio had the strongest association with gestational diabetes. In the second trimester measurement, women in the highest quartile had an almost 14-fold increase in risk when compared to the lowest quartile, after adjusting for potential confounders including prepregnancy body mass index and diabetes family history (adjusted odds ratio, 13.60; 95% confidence interval, 3.97-46.30), Dr. Rawal and her colleagues reported. The ratio of fT3:fT4 at the first trimester was also associated with increased risk (aOR, 8.63; 95% CI, 2.87-26.00).
Similarly, fT3 was positively associated with gestational diabetes at the first trimester (aOR, 4.25; 95% CI, 1.67-10.80) and second trimester (aOR, 3.89; 95% CI, 1.50-10.10), investigators reported.
By contrast, there was no association between fT4 or TSH and gestational diabetes, they found.
“These findings, in combination with previous evidence of thyroid-related adverse pregnancy outcomes, support the benefits of thyroid screening among pregnant women in early to mid pregnancy,” senior author Cuilin Zhang, MD, MPH, PhD, of the NICHD, said in a press statement.
Thyroid function abnormalities are relatively common in pregnant women and have been associated with obstetric complications such as pregnancy loss and premature delivery, investigators noted.
Previous evidence is sparse regarding a potential link between thyroid dysfunction and gestational diabetes. There are some prospective studies that show women with hypothyroidism have an increased incidence of gestational diabetes, Dr. Rawal and her colleagues wrote. Isolated hypothyroxinema, or normal TSH and low fT4, has also been linked to increased risk in some studies, but not in others, they added.
Support for the study came from NICHD and the American Recovery and Reinvestment Act research grants. The authors reported no conflicts of interest.
SOURCE: Rawal S et al. J Clin Endocrinol Metab. 2018 Jun 7. doi: 10.1210/jc.2017-024421.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM.
Key clinical point: Thyroid dysfunction early in pregnancy may increase risk of gestational diabetes.
Major finding: The triiodothyronine to thyroxine ratio in the second trimester had the strongest association with gestational diabetes (adjusted odds ratio, 13.60; 95% confidence interval, 3.97-46.30).
Study details: A case control study including 107 gestational diabetes cases and 214 nongestational diabetes controls.
Disclosures: The authors had no disclosures. Support for the study came from the National Institute of Child Health and Human Development and the American Recovery and Reinvestment Act research grants.
Source: Rawal S et al. J Clin Endocrinol Metab. 2018 Jun 7. doi: 10.1210/jc.2017-024421.
Trump proposes cutting Planned Parenthood funds
The planned revival of a policy dating to Ronald Reagan’s presidency may finally present a way for President Donald Trump to fulfill his campaign promise to “defund” Planned Parenthood. Or at least to evict it from the federal family planning program, where it provides care to more than 40% of that program’s 4 million patients.
The rules now under review, according to Trump administration officials, would require facilities receiving federal family planning funds to be physically separate from those that perform abortion; would eliminate the requirement that women with unintended pregnancies be counseled on their full range of reproductive options; and would ban abortion referrals.
All those changes would particularly affect Planned Parenthood.
Planned Parenthood, which provides a broad array of reproductive health services to women and men, also provides abortion services using nonfederal funds. Cutting off funding has been the top priority for anti-abortion groups, which supported candidate Trump.
“A win like this would immediately disentangle taxpayers from the abortion business and energize the grassroots as we head into the critical midterm elections,” Marjorie Dannenfelser, president of the anti-abortion Susan B. Anthony List, said in a statement.
In a conference call with reporters, Planned Parenthood officials said they would fight the new rules.
“We’ve been very clear, Planned Parenthood has an unwavering commitment to ensuring everyone has access to the full range of reproductive health care, and that includes abortion,” said Dawn Laguens, executive vice president of the Planned Parenthood Federation of America.
Here is a guide to what the proposal could do and what it could mean for Planned Parenthood and the family planning program:
What is Title X?
The federal family planning program, known as “Title Ten,” is named for its section in the federal Public Health Service Act. It became law in 1970, 3 years before the Supreme Court legalized abortion in Roe v Wade.
The original bill was sponsored by then Rep. George H.W. Bush (R-Texas) and signed into law by President Richard Nixon.
The program provides wellness exams and comprehensive contraceptive services, as well as screenings for cancer and sexually transmitted diseases for both women and men.
In 2016, the most recent year for which statistics have been published, Title X served 4 million patients at just under 4,000 sites.
Title X patients are overwhelmingly young, female, and low-income. An estimated 11% of Title X patients in 2016 were male; two-thirds of patients were under age 30; and nearly two-thirds had income below the federal poverty line.
What is Planned Parenthood’s relationship to Title X and Medicaid?
Planned Parenthood affiliates account for about 13% of total Title X sites but serve an estimated 40% of its patients. Only about half of Planned Parenthood affiliates perform abortions, although the organization in its entirety is the nation’s leading abortion provider.
Planned Parenthood also gets much more federal funding for services provided to patients on the Medicaid program (although not for abortion) than it does through Title X.
Eliminating Medicaid funding for Planned Parenthood has proved more difficult for lawmakers opposed to the organization because the federal Medicaid law includes the right for patients to select their providers. Changing that also would require a 60-vote majority in the Senate. So that particular line of funding is likely not at risk.
While opponents of federal funding for Planned Parenthood have said that other safety-net clinics could make up the difference if Planned Parenthood no longer participates in Title X, several studies have suggested that in many remote areas Planned Parenthood is the only provider of family planning services and the only provider that regularly stocks all methods of birth control.
Texas, Iowa, and Missouri in recent years have stopped offering family planning services through a special Medicaid program to keep from funding Planned Parenthood. Texas is seeking a waiver from the Trump administration so that its program banning abortion providers could still receive federal funding. No decision has been made yet, federal officials said.
Why is Planned Parenthood’s involvement with Title X controversial?
Even though Planned Parenthood cannot use federal funding for abortions, anti-abortion groups claim that federal funding is “fungible” and there is no way to ensure that some of the funding provided for other services does not cross-subsidize abortion services.
Planned Parenthood has also been a longtime public target for anti-abortion forces because it is such a visible provider and vocal proponent of legal abortion services.
In the early 1980s, the Reagan administration tried to separate the program from its federal funding by requiring parental permission for teens to obtain birth control. That was followed by efforts to eliminate abortion counseling.
Starting in 2011, undercover groups accused the organization of ignoring sex traffickers and selling fetal body parts in an effort to get the organization defunded. Planned Parenthood denies the allegations.
What happened the last time an administration tried to move Planned Parenthood out of Title X?
In 1987, the Reagan administration proposed what came to be known as the “gag rule.” Though the administration’s new proposal is not yet public, because the details are still under review by the Office of Management and Budget, the White House released a summary, saying the new rule will be similar although not identical to the Reagan-era proposal.
The original gag rule would have forbidden Title X providers from abortion counseling or referring patients for abortions, required physical separation of Title X and abortion-providing facilities and forbidden recipients from using nonfederal funds for lobbying, distributing information or in any way advocating or encouraging abortion. (The Planned Parenthood Federation of America, the umbrella group for local affiliates, has a separate political and advocacy arm, the Planned Parenthood Action Fund.)
Those rules were the subject of heated congressional debate through most of the George H.W. Bush administration and were upheld in a 5-4 Supreme Court ruling in 1991, Rust v Sullivan.
Even then, the gag rule did not go into effect because subsequent efforts to relax the rules somewhat to allow doctors (but not other health professionals) to counsel patients on the availability of abortion created another round of legal fights.
Eventually the rule was in effect for only about a month before it was again blocked by a U.S. appeals court. President Bill Clinton canceled the rules by executive order on his second day in office, and no other president tried to revive them until now.
How is the Trump administration’s proposal different from earlier rules?
According to the summary of the new proposal, released May 18, it will require physical separation of family planning and abortion facilities, repeal current counseling requirements, and ban abortion referrals.
One of the biggest differences, however, is that the new rules will not explicitly forbid abortion counseling by Title X providers.
But Planned Parenthood officials say that allowing counseling while banning referrals is a distinction without a difference.
Kashif Syed, a senior policy analyst for the organization said: “Blocking doctors from telling a patient where they can get safe and legal care in this country is the definition of a gag rule.”
What happens next?
All proposed rules are reviewed by the Office of Management and Budget. Sometimes they emerge and are published in a few days; sometimes they are rewritten, and it takes months.
Meanwhile, Planned Parenthood officials said they will not know if they will take legal action until they see the final language of the rule. But they say they do plan to use the regulatory process to fight the changes that have been made public so far.
KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
The planned revival of a policy dating to Ronald Reagan’s presidency may finally present a way for President Donald Trump to fulfill his campaign promise to “defund” Planned Parenthood. Or at least to evict it from the federal family planning program, where it provides care to more than 40% of that program’s 4 million patients.
The rules now under review, according to Trump administration officials, would require facilities receiving federal family planning funds to be physically separate from those that perform abortion; would eliminate the requirement that women with unintended pregnancies be counseled on their full range of reproductive options; and would ban abortion referrals.
All those changes would particularly affect Planned Parenthood.
Planned Parenthood, which provides a broad array of reproductive health services to women and men, also provides abortion services using nonfederal funds. Cutting off funding has been the top priority for anti-abortion groups, which supported candidate Trump.
“A win like this would immediately disentangle taxpayers from the abortion business and energize the grassroots as we head into the critical midterm elections,” Marjorie Dannenfelser, president of the anti-abortion Susan B. Anthony List, said in a statement.
In a conference call with reporters, Planned Parenthood officials said they would fight the new rules.
“We’ve been very clear, Planned Parenthood has an unwavering commitment to ensuring everyone has access to the full range of reproductive health care, and that includes abortion,” said Dawn Laguens, executive vice president of the Planned Parenthood Federation of America.
Here is a guide to what the proposal could do and what it could mean for Planned Parenthood and the family planning program:
What is Title X?
The federal family planning program, known as “Title Ten,” is named for its section in the federal Public Health Service Act. It became law in 1970, 3 years before the Supreme Court legalized abortion in Roe v Wade.
The original bill was sponsored by then Rep. George H.W. Bush (R-Texas) and signed into law by President Richard Nixon.
The program provides wellness exams and comprehensive contraceptive services, as well as screenings for cancer and sexually transmitted diseases for both women and men.
In 2016, the most recent year for which statistics have been published, Title X served 4 million patients at just under 4,000 sites.
Title X patients are overwhelmingly young, female, and low-income. An estimated 11% of Title X patients in 2016 were male; two-thirds of patients were under age 30; and nearly two-thirds had income below the federal poverty line.
What is Planned Parenthood’s relationship to Title X and Medicaid?
Planned Parenthood affiliates account for about 13% of total Title X sites but serve an estimated 40% of its patients. Only about half of Planned Parenthood affiliates perform abortions, although the organization in its entirety is the nation’s leading abortion provider.
Planned Parenthood also gets much more federal funding for services provided to patients on the Medicaid program (although not for abortion) than it does through Title X.
Eliminating Medicaid funding for Planned Parenthood has proved more difficult for lawmakers opposed to the organization because the federal Medicaid law includes the right for patients to select their providers. Changing that also would require a 60-vote majority in the Senate. So that particular line of funding is likely not at risk.
While opponents of federal funding for Planned Parenthood have said that other safety-net clinics could make up the difference if Planned Parenthood no longer participates in Title X, several studies have suggested that in many remote areas Planned Parenthood is the only provider of family planning services and the only provider that regularly stocks all methods of birth control.
Texas, Iowa, and Missouri in recent years have stopped offering family planning services through a special Medicaid program to keep from funding Planned Parenthood. Texas is seeking a waiver from the Trump administration so that its program banning abortion providers could still receive federal funding. No decision has been made yet, federal officials said.
Why is Planned Parenthood’s involvement with Title X controversial?
Even though Planned Parenthood cannot use federal funding for abortions, anti-abortion groups claim that federal funding is “fungible” and there is no way to ensure that some of the funding provided for other services does not cross-subsidize abortion services.
Planned Parenthood has also been a longtime public target for anti-abortion forces because it is such a visible provider and vocal proponent of legal abortion services.
In the early 1980s, the Reagan administration tried to separate the program from its federal funding by requiring parental permission for teens to obtain birth control. That was followed by efforts to eliminate abortion counseling.
Starting in 2011, undercover groups accused the organization of ignoring sex traffickers and selling fetal body parts in an effort to get the organization defunded. Planned Parenthood denies the allegations.
What happened the last time an administration tried to move Planned Parenthood out of Title X?
In 1987, the Reagan administration proposed what came to be known as the “gag rule.” Though the administration’s new proposal is not yet public, because the details are still under review by the Office of Management and Budget, the White House released a summary, saying the new rule will be similar although not identical to the Reagan-era proposal.
The original gag rule would have forbidden Title X providers from abortion counseling or referring patients for abortions, required physical separation of Title X and abortion-providing facilities and forbidden recipients from using nonfederal funds for lobbying, distributing information or in any way advocating or encouraging abortion. (The Planned Parenthood Federation of America, the umbrella group for local affiliates, has a separate political and advocacy arm, the Planned Parenthood Action Fund.)
Those rules were the subject of heated congressional debate through most of the George H.W. Bush administration and were upheld in a 5-4 Supreme Court ruling in 1991, Rust v Sullivan.
Even then, the gag rule did not go into effect because subsequent efforts to relax the rules somewhat to allow doctors (but not other health professionals) to counsel patients on the availability of abortion created another round of legal fights.
Eventually the rule was in effect for only about a month before it was again blocked by a U.S. appeals court. President Bill Clinton canceled the rules by executive order on his second day in office, and no other president tried to revive them until now.
How is the Trump administration’s proposal different from earlier rules?
According to the summary of the new proposal, released May 18, it will require physical separation of family planning and abortion facilities, repeal current counseling requirements, and ban abortion referrals.
One of the biggest differences, however, is that the new rules will not explicitly forbid abortion counseling by Title X providers.
But Planned Parenthood officials say that allowing counseling while banning referrals is a distinction without a difference.
Kashif Syed, a senior policy analyst for the organization said: “Blocking doctors from telling a patient where they can get safe and legal care in this country is the definition of a gag rule.”
What happens next?
All proposed rules are reviewed by the Office of Management and Budget. Sometimes they emerge and are published in a few days; sometimes they are rewritten, and it takes months.
Meanwhile, Planned Parenthood officials said they will not know if they will take legal action until they see the final language of the rule. But they say they do plan to use the regulatory process to fight the changes that have been made public so far.
KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
The planned revival of a policy dating to Ronald Reagan’s presidency may finally present a way for President Donald Trump to fulfill his campaign promise to “defund” Planned Parenthood. Or at least to evict it from the federal family planning program, where it provides care to more than 40% of that program’s 4 million patients.
The rules now under review, according to Trump administration officials, would require facilities receiving federal family planning funds to be physically separate from those that perform abortion; would eliminate the requirement that women with unintended pregnancies be counseled on their full range of reproductive options; and would ban abortion referrals.
All those changes would particularly affect Planned Parenthood.
Planned Parenthood, which provides a broad array of reproductive health services to women and men, also provides abortion services using nonfederal funds. Cutting off funding has been the top priority for anti-abortion groups, which supported candidate Trump.
“A win like this would immediately disentangle taxpayers from the abortion business and energize the grassroots as we head into the critical midterm elections,” Marjorie Dannenfelser, president of the anti-abortion Susan B. Anthony List, said in a statement.
In a conference call with reporters, Planned Parenthood officials said they would fight the new rules.
“We’ve been very clear, Planned Parenthood has an unwavering commitment to ensuring everyone has access to the full range of reproductive health care, and that includes abortion,” said Dawn Laguens, executive vice president of the Planned Parenthood Federation of America.
Here is a guide to what the proposal could do and what it could mean for Planned Parenthood and the family planning program:
What is Title X?
The federal family planning program, known as “Title Ten,” is named for its section in the federal Public Health Service Act. It became law in 1970, 3 years before the Supreme Court legalized abortion in Roe v Wade.
The original bill was sponsored by then Rep. George H.W. Bush (R-Texas) and signed into law by President Richard Nixon.
The program provides wellness exams and comprehensive contraceptive services, as well as screenings for cancer and sexually transmitted diseases for both women and men.
In 2016, the most recent year for which statistics have been published, Title X served 4 million patients at just under 4,000 sites.
Title X patients are overwhelmingly young, female, and low-income. An estimated 11% of Title X patients in 2016 were male; two-thirds of patients were under age 30; and nearly two-thirds had income below the federal poverty line.
What is Planned Parenthood’s relationship to Title X and Medicaid?
Planned Parenthood affiliates account for about 13% of total Title X sites but serve an estimated 40% of its patients. Only about half of Planned Parenthood affiliates perform abortions, although the organization in its entirety is the nation’s leading abortion provider.
Planned Parenthood also gets much more federal funding for services provided to patients on the Medicaid program (although not for abortion) than it does through Title X.
Eliminating Medicaid funding for Planned Parenthood has proved more difficult for lawmakers opposed to the organization because the federal Medicaid law includes the right for patients to select their providers. Changing that also would require a 60-vote majority in the Senate. So that particular line of funding is likely not at risk.
While opponents of federal funding for Planned Parenthood have said that other safety-net clinics could make up the difference if Planned Parenthood no longer participates in Title X, several studies have suggested that in many remote areas Planned Parenthood is the only provider of family planning services and the only provider that regularly stocks all methods of birth control.
Texas, Iowa, and Missouri in recent years have stopped offering family planning services through a special Medicaid program to keep from funding Planned Parenthood. Texas is seeking a waiver from the Trump administration so that its program banning abortion providers could still receive federal funding. No decision has been made yet, federal officials said.
Why is Planned Parenthood’s involvement with Title X controversial?
Even though Planned Parenthood cannot use federal funding for abortions, anti-abortion groups claim that federal funding is “fungible” and there is no way to ensure that some of the funding provided for other services does not cross-subsidize abortion services.
Planned Parenthood has also been a longtime public target for anti-abortion forces because it is such a visible provider and vocal proponent of legal abortion services.
In the early 1980s, the Reagan administration tried to separate the program from its federal funding by requiring parental permission for teens to obtain birth control. That was followed by efforts to eliminate abortion counseling.
Starting in 2011, undercover groups accused the organization of ignoring sex traffickers and selling fetal body parts in an effort to get the organization defunded. Planned Parenthood denies the allegations.
What happened the last time an administration tried to move Planned Parenthood out of Title X?
In 1987, the Reagan administration proposed what came to be known as the “gag rule.” Though the administration’s new proposal is not yet public, because the details are still under review by the Office of Management and Budget, the White House released a summary, saying the new rule will be similar although not identical to the Reagan-era proposal.
The original gag rule would have forbidden Title X providers from abortion counseling or referring patients for abortions, required physical separation of Title X and abortion-providing facilities and forbidden recipients from using nonfederal funds for lobbying, distributing information or in any way advocating or encouraging abortion. (The Planned Parenthood Federation of America, the umbrella group for local affiliates, has a separate political and advocacy arm, the Planned Parenthood Action Fund.)
Those rules were the subject of heated congressional debate through most of the George H.W. Bush administration and were upheld in a 5-4 Supreme Court ruling in 1991, Rust v Sullivan.
Even then, the gag rule did not go into effect because subsequent efforts to relax the rules somewhat to allow doctors (but not other health professionals) to counsel patients on the availability of abortion created another round of legal fights.
Eventually the rule was in effect for only about a month before it was again blocked by a U.S. appeals court. President Bill Clinton canceled the rules by executive order on his second day in office, and no other president tried to revive them until now.
How is the Trump administration’s proposal different from earlier rules?
According to the summary of the new proposal, released May 18, it will require physical separation of family planning and abortion facilities, repeal current counseling requirements, and ban abortion referrals.
One of the biggest differences, however, is that the new rules will not explicitly forbid abortion counseling by Title X providers.
But Planned Parenthood officials say that allowing counseling while banning referrals is a distinction without a difference.
Kashif Syed, a senior policy analyst for the organization said: “Blocking doctors from telling a patient where they can get safe and legal care in this country is the definition of a gag rule.”
What happens next?
All proposed rules are reviewed by the Office of Management and Budget. Sometimes they emerge and are published in a few days; sometimes they are rewritten, and it takes months.
Meanwhile, Planned Parenthood officials said they will not know if they will take legal action until they see the final language of the rule. But they say they do plan to use the regulatory process to fight the changes that have been made public so far.
KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Transgender care mandates endocrinologists share their expertise
BOSTON – Endocrinologists need to be familiar with new practice guidelines and changes in the landscape of transgender health care, Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York, said in a video interview at the annual meeting of the American Association of Clinical Endocrinologists.
“We endocrinologists ... need to be able to help (gender-dysphoric/gender-incongruent) individuals, even if it’s just an occasional patient, to do what is safe and to be expert (in transgender health care), just as we are with other hormone treatments,” he said in a discussion of aspects of the Endocrine Society clinical practice guideline on endocrine treatment of gender-dysphoric/gender-incongruent individuals.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The new guidelines, published in November 2017, update 2009 guidance from the society. Among the big changes are the recognition that there may be “compelling reasons” to start cross-sex hormonal therapy prior to the old age cutoff of 16 years, which is “very late if you’re thinking about it from a biological perspective,” said Dr. Safer.
Another major change challenges the idea that a mental health professional is necessary to diagnose adults. Rather, any knowledgeable clinician could make the diagnosis, according to Dr. Safer.
The guidelines also recommend that endocrinologists provide education regarding onset and time course of physical changes induced by sex hormone treatments to transgender individuals undergoing treatment.
BOSTON – Endocrinologists need to be familiar with new practice guidelines and changes in the landscape of transgender health care, Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York, said in a video interview at the annual meeting of the American Association of Clinical Endocrinologists.
“We endocrinologists ... need to be able to help (gender-dysphoric/gender-incongruent) individuals, even if it’s just an occasional patient, to do what is safe and to be expert (in transgender health care), just as we are with other hormone treatments,” he said in a discussion of aspects of the Endocrine Society clinical practice guideline on endocrine treatment of gender-dysphoric/gender-incongruent individuals.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The new guidelines, published in November 2017, update 2009 guidance from the society. Among the big changes are the recognition that there may be “compelling reasons” to start cross-sex hormonal therapy prior to the old age cutoff of 16 years, which is “very late if you’re thinking about it from a biological perspective,” said Dr. Safer.
Another major change challenges the idea that a mental health professional is necessary to diagnose adults. Rather, any knowledgeable clinician could make the diagnosis, according to Dr. Safer.
The guidelines also recommend that endocrinologists provide education regarding onset and time course of physical changes induced by sex hormone treatments to transgender individuals undergoing treatment.
BOSTON – Endocrinologists need to be familiar with new practice guidelines and changes in the landscape of transgender health care, Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York, said in a video interview at the annual meeting of the American Association of Clinical Endocrinologists.
“We endocrinologists ... need to be able to help (gender-dysphoric/gender-incongruent) individuals, even if it’s just an occasional patient, to do what is safe and to be expert (in transgender health care), just as we are with other hormone treatments,” he said in a discussion of aspects of the Endocrine Society clinical practice guideline on endocrine treatment of gender-dysphoric/gender-incongruent individuals.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The new guidelines, published in November 2017, update 2009 guidance from the society. Among the big changes are the recognition that there may be “compelling reasons” to start cross-sex hormonal therapy prior to the old age cutoff of 16 years, which is “very late if you’re thinking about it from a biological perspective,” said Dr. Safer.
Another major change challenges the idea that a mental health professional is necessary to diagnose adults. Rather, any knowledgeable clinician could make the diagnosis, according to Dr. Safer.
The guidelines also recommend that endocrinologists provide education regarding onset and time course of physical changes induced by sex hormone treatments to transgender individuals undergoing treatment.
REPORTING FROM AACE 2018
Do black women pay a price for hair care regimens?
A new analysis of 18 hair products used by black women finds that they contain 45 endocrine-disrupting or asthma-associated chemicals, a finding that could help explain why this population suffers from higher rates of chemical exposure and hormone-related health conditions.
“We found multiples of our targeted chemicals in all of our products,” said study lead author Jessica S. Helm, PhD, of the Silent Spring Institute, Newton, Mass., in an interview. “We’re concerned about the additive effect of multiple products being used together.”
According to the study, previous research has found that, compared with white women, U.S. black women have higher urinary levels of chemicals like phthalates and parabens. Black women also have higher rates of asthma and hormone-related health conditions like uterine fibroids and infertility, Dr. Helms said.
The researchers launched their study to better understand the possible role of hair care products in raising chemical levels in black women, Dr. Helm said.
The researchers tested 18 types of hair care products shown by a 2004-2005 survey to be popular among black women: hot oil treatments, anti-frizz products and polishes, leave-in conditioners, root stimulators, hair lotions, and relaxers. Researchers had purchased the products in 2008.
The researchers detected 45 of 66 target chemicals in the samples, including some that are banned in the European Union or regulated in California based on health concerns, according to Dr. Helms.
Most of the products contained parabens and phthalates (both 78%), UV filters (72%), and cyclosiloxanes (67%).
All products contained at least 1 of 19 targeted fragrances, while “hair lotions, root stimulators, and hair relaxers contained multiple fragrance chemicals per product, with an average of five to eight targeted fragrance chemicals detected per product versus an average of two in the anti-frizz products.”
How do the findings compare with previous research? “They’re roughly consistent with what’s been found before, but potentially on the higher end,” Dr. Helms said. “For some of these chemicals, there’s not a lot of data from the past.”
Most of the chemicals aren’t listed on product labels, Dr. Helm said. “It’s possible that some of the ingredients were unintentionally added as part of manufacturing or other processes.”
Dr. Helm urged physicians to consider the connections between hair care products and chemical exposure. “Maybe there’s an opportunity to use fewer products,” she said.
Dr. Helm acknowledged that it is difficult to find hair care products that don’t include fragrance. She recommends the use of products made from plants or organic ingredients, and she pointed to a Silver Spring Institute–affiliated app called DetoxMe that offers suggestions about reducing chemical exposure from consumer products.
The study was funded by the Rose Foundation, the Goldman Fund, and Hurricane Voices Breast Cancer Foundation. The authors report no relevant disclosures.
SOURCE: Helm JS et al. Environ Res. 2018 Apr 25. doi: 10.1016/j.envres.2018.03.030.
A new analysis of 18 hair products used by black women finds that they contain 45 endocrine-disrupting or asthma-associated chemicals, a finding that could help explain why this population suffers from higher rates of chemical exposure and hormone-related health conditions.
“We found multiples of our targeted chemicals in all of our products,” said study lead author Jessica S. Helm, PhD, of the Silent Spring Institute, Newton, Mass., in an interview. “We’re concerned about the additive effect of multiple products being used together.”
According to the study, previous research has found that, compared with white women, U.S. black women have higher urinary levels of chemicals like phthalates and parabens. Black women also have higher rates of asthma and hormone-related health conditions like uterine fibroids and infertility, Dr. Helms said.
The researchers launched their study to better understand the possible role of hair care products in raising chemical levels in black women, Dr. Helm said.
The researchers tested 18 types of hair care products shown by a 2004-2005 survey to be popular among black women: hot oil treatments, anti-frizz products and polishes, leave-in conditioners, root stimulators, hair lotions, and relaxers. Researchers had purchased the products in 2008.
The researchers detected 45 of 66 target chemicals in the samples, including some that are banned in the European Union or regulated in California based on health concerns, according to Dr. Helms.
Most of the products contained parabens and phthalates (both 78%), UV filters (72%), and cyclosiloxanes (67%).
All products contained at least 1 of 19 targeted fragrances, while “hair lotions, root stimulators, and hair relaxers contained multiple fragrance chemicals per product, with an average of five to eight targeted fragrance chemicals detected per product versus an average of two in the anti-frizz products.”
How do the findings compare with previous research? “They’re roughly consistent with what’s been found before, but potentially on the higher end,” Dr. Helms said. “For some of these chemicals, there’s not a lot of data from the past.”
Most of the chemicals aren’t listed on product labels, Dr. Helm said. “It’s possible that some of the ingredients were unintentionally added as part of manufacturing or other processes.”
Dr. Helm urged physicians to consider the connections between hair care products and chemical exposure. “Maybe there’s an opportunity to use fewer products,” she said.
Dr. Helm acknowledged that it is difficult to find hair care products that don’t include fragrance. She recommends the use of products made from plants or organic ingredients, and she pointed to a Silver Spring Institute–affiliated app called DetoxMe that offers suggestions about reducing chemical exposure from consumer products.
The study was funded by the Rose Foundation, the Goldman Fund, and Hurricane Voices Breast Cancer Foundation. The authors report no relevant disclosures.
SOURCE: Helm JS et al. Environ Res. 2018 Apr 25. doi: 10.1016/j.envres.2018.03.030.
A new analysis of 18 hair products used by black women finds that they contain 45 endocrine-disrupting or asthma-associated chemicals, a finding that could help explain why this population suffers from higher rates of chemical exposure and hormone-related health conditions.
“We found multiples of our targeted chemicals in all of our products,” said study lead author Jessica S. Helm, PhD, of the Silent Spring Institute, Newton, Mass., in an interview. “We’re concerned about the additive effect of multiple products being used together.”
According to the study, previous research has found that, compared with white women, U.S. black women have higher urinary levels of chemicals like phthalates and parabens. Black women also have higher rates of asthma and hormone-related health conditions like uterine fibroids and infertility, Dr. Helms said.
The researchers launched their study to better understand the possible role of hair care products in raising chemical levels in black women, Dr. Helm said.
The researchers tested 18 types of hair care products shown by a 2004-2005 survey to be popular among black women: hot oil treatments, anti-frizz products and polishes, leave-in conditioners, root stimulators, hair lotions, and relaxers. Researchers had purchased the products in 2008.
The researchers detected 45 of 66 target chemicals in the samples, including some that are banned in the European Union or regulated in California based on health concerns, according to Dr. Helms.
Most of the products contained parabens and phthalates (both 78%), UV filters (72%), and cyclosiloxanes (67%).
All products contained at least 1 of 19 targeted fragrances, while “hair lotions, root stimulators, and hair relaxers contained multiple fragrance chemicals per product, with an average of five to eight targeted fragrance chemicals detected per product versus an average of two in the anti-frizz products.”
How do the findings compare with previous research? “They’re roughly consistent with what’s been found before, but potentially on the higher end,” Dr. Helms said. “For some of these chemicals, there’s not a lot of data from the past.”
Most of the chemicals aren’t listed on product labels, Dr. Helm said. “It’s possible that some of the ingredients were unintentionally added as part of manufacturing or other processes.”
Dr. Helm urged physicians to consider the connections between hair care products and chemical exposure. “Maybe there’s an opportunity to use fewer products,” she said.
Dr. Helm acknowledged that it is difficult to find hair care products that don’t include fragrance. She recommends the use of products made from plants or organic ingredients, and she pointed to a Silver Spring Institute–affiliated app called DetoxMe that offers suggestions about reducing chemical exposure from consumer products.
The study was funded by the Rose Foundation, the Goldman Fund, and Hurricane Voices Breast Cancer Foundation. The authors report no relevant disclosures.
SOURCE: Helm JS et al. Environ Res. 2018 Apr 25. doi: 10.1016/j.envres.2018.03.030.
Key clinical point: Endocrine-disrupting and asthma-associated chemicals are commonly found in hair care products used by black women.
Major finding: Of the 66 target chemicals, 45 were found in the 18 products tested.
Study details: Analysis of 18 hair care products purchased in 2008.
Disclosures: The study was funded by the Goldman Fund, Hurricane Voices Breast Cancer Foundation, and the Rose Foundation. The authors report no relevant disclosures.
Source: Helm JS et al. Environ Res. 2018 Apr 25. doi: 10.1016/j.envres.2018.03.030.