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OBJECTIVE: We sought to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women who received tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap). STUDY DESIGN: We searched VAERS for reports of pregnant women who received Tdap from Jan. 1, 2005, through June 30, 2010. We conducted a clinical review of reports and available medical records. RESULTS: We identified 132 reports of Tdap administered to pregnant women; 55 (42%) described no adverse event (AE). No maternal or infant deaths were reported. The most frequent pregnancy-specific AE was spontaneous abortion in 22 (16.7%) reports. Injection site reactions were the most frequent non-pregnancy-specific AE found in 6 (4.5%) reports. One report with a major congenital anomaly (gastroschisis) was identified. CONCLUSION: During a time when Tdap was not routinely recommended in pregnancy, review of reports to VAERS in pregnant women after Tdap did not identify any concerning patterns in maternal, infant, or fetal outcomes. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The purpose of this study was to estimate US rates of postpartum intrauterine device (IUD) insertion and postpartum tubal sterilization. STUDY DESIGN: Data from the 2001-2008 Nationwide Inpatient Sample were used to identify delivery hospitalizations with IUD insertion or tubal sterilization procedure codes. RESULTS: Estimated rates of postpartum IUD insertion and postpartum tubal sterilization were 0.27 and 770.67 per 10,000 deliveries, respectively. Although the rate of IUD insertion was similar across age groups, the rate of tubal sterilization increased with age. Nonetheless, 15% of tubal sterilizations occurred among women who were <=24 years old. IUD insertion was more likely among women who delivered at teaching hospitals (odds ratio, 3.02; 95% confidence interval, 1.43-6.37); tubal sterilization was more likely among women without private insurance (odds ratio, 2.04; 95% confidence interval, 1.97-2.11). CONCLUSION: Among US postpartum women, IUD insertion occurs considerably less frequently than tubal sterilization, even among younger women for whom poststerilization regret is a concern. [ABSTRACT FROM AUTHOR]

The 2024 U.S. Selected Practice Recommendations for Contraceptive Use (U.S. SPR) addresses a selected group of common, yet sometimes complex, issues regarding initiation and use of specific contraceptive methods. These recommendations for health care providers were updated by CDC after review of the scientific evidence and a meeting with national experts in Atlanta, Georgia, during January 25-27, 2023. The information in this report replaces the 2016 U.S. SPR (CDC. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR 2016;65[No. RR-4]:1-66). Notable updates include 1) updated recommendations for provision of medications for intrauterine device placement, 2) updated recommendations for bleeding irregularities during implant use, 3) new recommendations for testosterone use and risk for pregnancy, and 4) new recommendations for self-administration of injectable contraception. The recommendations in this report are intended to serve as a source of evidence-based clinical practice guidance for health care providers. The goals of these recommendations are to remove unnecessary medical barriers to accessing and using contraception and to support the provision of person-centered contraceptive counseling and services in a noncoercive manner. Health care providers should always consider the individual clinical circumstances of each person seeking contraceptive services. This report is not intended to be a substitute for professional medical advice for individual patients; when needed, patients should seek advice from their health care providers about contraceptive use., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed. To promote transparency, all meeting participants were asked to disclose potential conflicts of interest to CDC before the expert meeting and to report potential conflicts of interest during the introductory portion of the expert meeting. All potential conflicts of interest disclosed by meeting participants are listed. No participants were excluded from discussion based on potential conflicts of interest. CDC staff members who ultimately decided and developed these recommendations have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters relevant to these recommendations.

The 2024 U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) comprises recommendations for the use of specific contraceptive methods by persons who have certain characteristics or medical conditions. These recommendations for health care providers were updated by CDC after review of the scientific evidence and a meeting with national experts in Atlanta, Georgia, during January 25-27, 2023. The information in this report replaces the 2016 U.S. MEC (CDC. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR 2016:65[No. RR-3]:1-103). Notable updates include 1) the addition of recommendations for persons with chronic kidney disease; 2) revisions to the recommendations for persons with certain characteristics or medical conditions (i.e., breastfeeding, postpartum, postabortion, obesity, surgery, deep venous thrombosis or pulmonary embolism with or without anticoagulant therapy, thrombophilia, superficial venous thrombosis, valvular heart disease, peripartum cardiomyopathy, systemic lupus erythematosus, high risk for HIV infection, cirrhosis, liver tumor, sickle cell disease, solid organ transplantation, and drug interactions with antiretrovirals used for prevention or treatment of HIV infection); and 3) inclusion of new contraceptive methods, including new doses or formulations of combined oral contraceptives, contraceptive patches, vaginal rings, progestin-only pills, levonorgestrel intrauterine devices, and vaginal pH modulator. The recommendations in this report are intended to serve as a source of evidence-based clinical practice guidance for health care providers. The goals of these recommendations are to remove unnecessary medical barriers to accessing and using contraception and to support the provision of person-centered contraceptive counseling and services in a noncoercive manner. Health care providers should always consider the individual clinical circumstances of each person seeking contraceptive services. This report is not intended to be a substitute for professional medical advice for individual patients; when needed, patients should seek advice from their health care providers about contraceptive use., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed. To promote transparency, all meeting participants were asked to disclose potential conflicts of interest to CDC before the expert meeting and to report potential conflicts of interest during the introductory portion of the expert meeting. All potential conflicts of interest disclosed by meeting participants are listed. No participants were excluded from discussion based on potential conflicts of interest. CDC staff members who ultimately decided and developed these recommendations have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters relevant to these recommendations.

Background: There is evidence suggesting that COVID-19 vaccination may be associated with small, transitory effects on uterine bleeding, possibly including menstrual timing, flow, and duration, in some individuals. However, changes in health care seeking, diagnosis, and workup for abnormal uterine bleeding in the COVID-19 vaccine era are less clear., Objective: This study aimed to assess the impact of COVID-19 vaccination on incident abnormal uterine bleeding diagnosis and diagnostic evaluation in a large integrated health system., Study Design: Using segmented regression, we assessed whether the availability of COVID-19 vaccines was associated with changes in monthly, population-based rates of incident abnormal uterine bleeding diagnoses relative to the prepandemic period in health system members aged 16 to 44 years who were not menopausal. We also compared clinical and demographic characteristics of patients diagnosed with incident abnormal uterine bleeding between December 2020 and October 13, 2021 by vaccination status (never vaccinated, vaccinated in the 60 days before diagnosis, vaccinated >60 days before diagnosis). Furthermore, we conducted detailed chart review of patients diagnosed with abnormal uterine bleeding within 1 to 60 days of COVID-19 vaccination in the same time period., Results: In monthly populations ranging from 79,000 to 85,000 female health system members, incidence of abnormal uterine bleeding diagnosis per 100,000 person-days ranged from 8.97 to 19.19. There was no significant change in the level or trend in the incidence of abnormal uterine bleeding diagnoses between the prepandemic (January 2019-January 2020) and post-COVID-19 vaccine (December 2020-December 2021) periods. A comparison of clinical characteristics of 2717 abnormal uterine bleeding cases by vaccination status suggested that abnormal bleeding among recently vaccinated patients was similar or less severe than abnormal bleeding among patients who had never been vaccinated or those vaccinated >60 days before. There were also significant differences in age and race of patients with incident abnormal uterine bleeding diagnoses by vaccination status (Ps<.02). Never-vaccinated patients were the youngest and those vaccinated >60 days before were the oldest. The proportion of patients who were Black/African American was highest among never-vaccinated patients, and the proportion of Asian patients was higher among vaccinated patients. Chart review of 114 confirmed postvaccination abnormal uterine bleeding cases diagnosed from December 2020 through October 13, 2021 found that the most common symptoms reported were changes in timing, duration, and volume of bleeding. Approximately one-third of cases received no diagnostic workup; 57% had no etiology for the bleeding documented in the electronic health record. In 12% of cases, the patient mentioned or asked about a possible link between their bleeding and their recent COVID-19 vaccine., Conclusion: The availability of COVID-19 vaccination was not associated with a change in incidence of medically attended abnormal uterine bleeding in our population of over 79,000 female patients of reproductive age. In addition, among 2717 patients with abnormal uterine bleeding diagnoses in the period following COVID-19 vaccine availability, receipt of the vaccine was not associated with greater bleeding severity., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Gastroschisis has increased worldwide over several decades; however, there are significant gaps in understanding risk factors for development of the defect, particularly those that might be modifiable. Despite advances in survival, little is known about longer-term outcomes for affected individuals., Methods: On April 27- and 28, 2023, the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention (CDC) and March of Dimes sponsored a meeting entitled "Public Health Priorities for Gastroschisis". The meeting goals were to review current knowledge on gastroschisis, discuss research gaps, and identify future priorities for public health surveillance, research, and action related to gastroschisis. Meeting participants encompassed a broad range of expertise and experience, including public health, clinical care of individuals with gastroschisis, affected individuals and families, and representatives from professional organizations and federal agencies., Results: Several goals were identified for future public health surveillance and research, including focused theory-driven research on risk factors and increased study of longer-term effects of gastroschisis through improved surveillance. Certain public health actions were identified, that which could improve the care of affected individuals, including increased education of providers and enhanced resources for patients and families., Conclusions: These efforts may lead to an improved understanding of pathogenesis, risk factors, and outcomes and to improved care throughout the lifespan., (© 2024 Wiley Periodicals LLC. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

Background: There is a growing literature base regarding menstrual changes following COVID-19 vaccination among premenopausal people. However, relatively little is known about uterine bleeding in postmenopausal people following COVID-19 vaccination., Objective: This study aimed to examine trends in incident postmenopausal bleeding diagnoses over time before and after COVID-19 vaccine introduction, and to describe cases of new-onset postmenopausal bleeding after COVID-19 vaccination., Study Design: For postmenopausal bleeding incidence calculations, monthly population-level cohorts consisted of female Kaiser Permanente Northwest members aged ≥45 years. Those diagnosed with incident postmenopausal bleeding in the electronic medical record were included in monthly numerators. Members with preexisting postmenopausal bleeding or abnormal uterine bleeding, or who were at increased risk of bleeding due to other health conditions, were excluded from monthly calculations. We used segmented regression analysis to estimate changes in the incidence of postmenopausal bleeding diagnoses from 2018 through 2021 in Kaiser Permanente Northwest members meeting the inclusion criteria, stratified by COVID-19 vaccination status in 2021. In addition, we identified all members with ≥1 COVID-19 vaccination between December 14, 2020 and August 14, 2021, who had an incident postmenopausal bleeding diagnosis within 60 days of vaccination. COVID-19 vaccination, diagnostic procedures, and presumed bleeding etiology were assessed through chart review and described. A temporal scan statistic was run on all cases without clear bleeding etiology., Results: In a population of 75,530 to 82,693 individuals per month, there was no statistically significant difference in the rate of incident postmenopausal bleeding diagnoses before and after COVID-19 vaccine introduction (P=.59). A total of 104 individuals had incident postmenopausal bleeding diagnosed within 60 days following COVID-19 vaccination; 76% of cases (79/104) were confirmed as postvaccination postmenopausal bleeding after chart review. Median time from vaccination to bleeding onset was 21 days (range: 2-54 days). Among the 56 postmenopausal bleeding cases with a provider-attributed etiology, the common causes of bleeding were uterine or cervical lesions (50% [28/56]), hormone replacement therapy (13% [7/56]), and proliferative endometrium (13% [7/56]). Among the 23 cases without a clear etiology, there was no statistically significant clustering of postmenopausal bleeding onset following vaccination., Conclusion: Within this integrated health system, introduction of COVID-19 vaccines was not associated with an increase in incident postmenopausal bleeding diagnoses. Diagnosis of postmenopausal bleeding in the 60 days following receipt of a COVID-19 vaccination was rare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Respiratory syncytial virus (RSV) is the leading cause of hospitalization among U.S. infants. Nirsevimab (Bevfortus, Sanofi and AstraZeneca) is recommended to prevent RSV-associated lower respiratory tract infection (LRTI) in infants. In August 2023, the Food and Drug Administration (FDA) approved RSVpreF vaccine (Abrysvo, Pfizer Inc.) for pregnant persons as a single dose during 32-36 completed gestational weeks (i.e., 32 weeks and zero days' through 36 weeks and 6 days' gestation) to prevent RSV-associated lower respiratory tract disease in infants aged <6 months. Since October 2021, CDC's Advisory Committee on Immunization Practices (ACIP) RSV Vaccines Pediatric/Maternal Work Group has reviewed RSV epidemiology and evidence regarding safety, efficacy, and potential economic impact of pediatric and maternal RSV prevention products, including RSVpreF vaccine. On September 22, 2023, ACIP and CDC recommended RSVpreF vaccine using seasonal administration (i.e., during September through end of January in most of the continental United States) for pregnant persons as a one-time dose at 32-36 weeks' gestation for prevention of RSV-associated LRTI in infants aged <6 months. Either maternal RSVpreF vaccination during pregnancy or nirsevimab administration to the infant is recommended to prevent RSV-associated LRTI among infants, but both are not needed for most infants. All infants should be protected against RSV-associated LRTI through use of one of these products., Competing Interests: All authors and work group members have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

This report provides an overview of the unique reproductive health issues facing women with congenital heart defects (CHDs) and of the clinical care and professional guidelines on contraception, preconception care, and pregnancy for this population. It describes Centers for Disease Control and Prevention (CDC) activities related to surveillance of reproductive health issues among females with CHDs. It also describes CDC's work bringing awareness to physicians who provide care to adolescents and women with CHDs, including obstetrician/gynecologists, about the need for lifelong cardiology care for their patients with CHDs.

Background: Thrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. It presents similarly to spontaneous heparin-induced thrombocytopenia. Twelve cases of cerebral venous sinus thrombosis after vaccination with the Ad26.COV2.S COVID-19 vaccine (Janssen/Johnson & Johnson) have previously been described., Objective: To describe surveillance data and reporting rates of all reported TTS cases after COVID-19 vaccination in the United States., Design: Case series., Setting: United States., Patients: Case patients receiving a COVID-19 vaccine from 14 December 2020 through 31 August 2021 with thrombocytopenia and thrombosis (excluding isolated ischemic stroke or myocardial infarction) reported to the Vaccine Adverse Event Reporting System. If thrombosis was only in an extremity vein or pulmonary embolism, a positive enzyme-linked immunosorbent assay for antiplatelet factor 4 antibodies or functional heparin-induced thrombocytopenia platelet test result was required., Measurements: Reporting rates (cases per million vaccine doses) and descriptive epidemiology., Results: A total of 57 TTS cases were confirmed after vaccination with Ad26.COV2.S ( n  = 54) or a messenger RNA (mRNA)-based COVID-19 vaccine ( n  = 3). Reporting rates for TTS were 3.83 per million vaccine doses (Ad26.COV2.S) and 0.00855 per million vaccine doses (mRNA-based COVID-19 vaccines). The median age of patients with TTS after Ad26.COV2.S vaccination was 44.5 years (range, 18 to 70 years), and 69% of patients were women. Of the TTS cases after mRNA-based COVID-19 vaccination, 2 occurred in men older than 50 years and 1 in a woman aged 50 to 59 years. All cases after Ad26.COV2.S vaccination involved hospitalization, including 36 (67%) with intensive care unit admission. Outcomes of hospitalizations after Ad26.COV2.S vaccination included death (15%), discharge to postacute care (17%), and discharge home (68%)., Limitations: Underreporting and incomplete case follow-up., Conclusion: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination. The different demographic characteristics of the 3 cases reported after mRNA-based COVID-19 vaccines and the much lower reporting rate suggest that these cases represent a background rate., Primary Funding Source: Centers for Disease Control and Prevention.

Competing Interests: CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no conflicts of interest relevant to this article to disclose.

Background: Some studies have reported associations between prenatal use of venlafaxine, a serotonin-norepinephrine reuptake inhibitor used for depressive and anxiety disorders, and some birth defects. We described the prevalence of venlafaxine prescription claims among privately insured women of reproductive age and pregnant women., Methods: Venlafaxine prescription claims were examined using the IBM MarketScan Commercial Databases. We included women of reproductive age (15-44 years) who had ≤45 days of lapsed enrollment during the calendar year of interest (2011-2016) in a non-capitated healthcare plan sponsored by a large, self-insured employer with prescription drug coverage and no mental health service carve-out. Annual cohorts of pregnant women were identified among eligible women of reproductive age via pregnancy diagnosis and procedure codes. Venlafaxine prescriptions were identified via National Drug Codes in outpatient pharmacy claims and we estimated the annual proportion of women with venlafaxine claims by pregnancy trimester (pregnant women only), age, and Census division., Results: Each year during 2011-2016, approximately 1.2% of eligible reproductive-aged and 0.3% of eligible pregnant women filled a venlafaxine prescription. Among pregnant women, the proportion with venlafaxine claims was highest during the first trimester and decreased during the second and third trimesters. Small temporal increases in venlafaxine claims were observed for reproductive-aged and pregnant women, with the largest among women aged 15-19 years., Conclusions: Venlafaxine prescription claims were low among women of reproductive age and pregnant women during 2011-2016, with some increasing use over time among women aged 15-19 years., (Published 2021. This article is a U.S. Government work and is in the public domain in the USA.)

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for vaccine use; currently Pfizer-BioNTech is authorized and recommended for persons aged ≥12 years and Moderna and Janssen for persons aged ≥18 years (1-3). Both Pfizer-BioNTech and Moderna vaccines, administered as 2-dose series, are mRNA-based COVID-19 vaccines, whereas the Janssen COVID-19 vaccine, administered as a single dose, is a recombinant replication-incompetent adenovirus-vector vaccine. As of July 22, 2021, 187 million persons in the United States had received at least 1 dose of COVID-19 vaccine (4); close monitoring of safety surveillance has demonstrated that serious adverse events after COVID-19 vaccination are rare (5,6). Three medical conditions have been reported in temporal association with receipt of COVID-19 vaccines. Two of these (thrombosis with thrombocytopenia syndrome [TTS], a rare syndrome characterized by venous or arterial thrombosis and thrombocytopenia, and Guillain-Barré syndrome [GBS], a rare autoimmune neurologic disorder characterized by ascending weakness and paralysis) have been reported after Janssen COVID-19 vaccination. One (myocarditis, cardiac inflammation) has been reported after Pfizer-BioNTech COVID-19 vaccination or Moderna COVID-19 vaccination, particularly after the second dose; these were reviewed together and will hereafter be referred to as mRNA COVID-19 vaccination. ACIP has met three times to review the data associated with these reports of serious adverse events and has comprehensively assessed the benefits and risks associated with receipt of these vaccines. During the most recent meeting in July 2021, ACIP determined that, overall, the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events in adults aged ≥18 years; this balance of benefits and risks varied by age and sex. ACIP continues to recommend COVID-19 vaccination in all persons aged ≥12 years. CDC and FDA continue to closely monitor reports of serious adverse events and will present any additional data to ACIP for consideration. Information regarding risks and how they vary by age and sex and type of vaccine should be disseminated to providers, vaccine recipients, and the public., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Nicola P. Klein reports institutional research support from Pfizer, Sanofi Pasteur, Merck, GlaxoSmithKline, and Protein Science (now Sanofi Pasteur). No other potential conflicts of interest were disclosed.

Objective(s): We estimated the prevalence of requiring specific examinations or tests before providing contraception in a nationwide survey of family planning providers., Study Design: We conducted a cross-sectional survey of public-sector health centers and office-based physicians providing family planning services across the United States in 2019 (n = 1395). We estimated the weighted proportion of providers (or their health center or practice) who required blood pressure measurement, pelvic examination (bimanual examination and cervical inspection), Papanicolaou (Pap) smear, clinical breast examination (CBE), and chlamydia and gonorrhea (CT/GC) screening before initiating hormonal or intrauterine contraception (IUC) for healthy women. We performed multivariable regression to identify factors associated with pelvic examination practices aligned with clinical recommendations; these recommendations classify examinations and tests as recommended or unnecessary before initiation of specific contraceptive methods., Results: The overall response rate was 51%. Most providers required blood pressure measurement before initiating each method. Unnecessary CBE, Pap smears, and CT/GC screening were required by 14% to 33% of providers across methods. Fifty-two to 62% of providers required recommended pelvic examination before IUC placement; however, 16% to 23% of providers required unnecessary pelvic examinations before non-intrauterine hormonal method initiation. Factors associated with recommendation-aligned pelvic examination practices included having a higher proportion of patients using public funding (Medicaid or other assistance) and more recently completing formal clinical training., Conclusions: Almost half (47%) of providers did not require necessary pelvic examination before placing IUC. Conversely, many providers required unnecessary examinations and tests before contraception initiation for patients., Implications: Most providers required the few recommended examinations and tests for safe contraceptive provision. Reduction of unnecessary examinations and tests may reduce barriers to contraceptive access. There are also opportunities to increase use of recommended examinations, as up to 48% of providers did not require recommended pelvic examination before IUC., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: To evaluate whether the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccinations in pregnancy are associated with increased risk of stillbirth., Methods: We performed a case-control study in the Vaccine Safety Datalink that was matched 1:4 on site, month, and year of last menstrual period, comparing the odds of vaccination in pregnancies that ended in stillbirth (defined as fetal loss at or after 20 weeks of gestation) compared with those that ended in live birth from January 1, 2012, to September 30, 2015. We included patients with singleton pregnancies that ended in stillbirth or live birth who had at least one prenatal care visit, pregnancy dating information, and continuous health plan enrollment for the duration of pregnancy. Medical records for all stillbirths were reviewed. We were statistically powered to detect an odds ratio (OR) of 1.37 when evaluating the association between influenza or Tdap vaccination and stillbirth. We also examined stillbirth rates in pregnant patients aged 14-49 years in the Vaccine Safety Datalink between 2007 and 2015., Results: In our matched analysis of 795 confirmed stillbirths in the case group and 3,180 live births in the control group, there was no significant association between influenza vaccination during pregnancy and stillbirth (343/795 [43.1%] stillbirths in the case group vs 1,407/3,180 [44.3%] live births in the control group, OR 0.94, adjusted OR 0.95, 95% CI 0.79-1.14, P=.54) and no significant association between Tdap vaccination during pregnancy and stillbirth (184/795 [23.1%] stillbirths in the case group vs 746/3,180 [23.5%] live births in the control group, OR 0.97, aOR 0.96, 95% CI 0.76-1.28, P=.91). From 2007 to 2015, the stillbirth rate in the Vaccine Safety Datalink was 5.2 per 1,000 live births and stillbirths., Conclusion: No association was found between vaccination during pregnancy and the odds of stillbirth. These findings support the safety of ACIP recommendations for vaccination during pregnancy.

Objectives: To provide updated and more detailed pooled intrauterine device expulsion rates and expulsion risk estimates among women with postpartum intrauterine device placement by timing of insertion, delivery type, and intrauterine device type to inform current intrauterine device insertion practices in the United States., Data Sources: We searched PubMed, Cochrane Library, and ClinicalTrials.gov through June 2019., Study Eligibility Criteria: We included all studies, of any study design, that examined postpartum placement of Copper T380A (copper) or levonorgestrel-containing intrauterine devices that reported counts of expulsion., Study Appraisal and Synthesis Methods: We evaluated intrauterine device expulsion among women receiving postpartum intrauterine devices in the "immediate" (within 10 minutes), "early inpatient" (>10 minutes to <72 hours), "early outpatient" (72 hours to <4 weeks), and interval (≥4 weeks) time periods after delivery. We assessed study quality using the US Preventive Services Task Force evidence grading system. We calculated pooled absolute rates of partial and complete intrauterine device expulsion separately and estimated adjusted relative risks by the timing of postpartum placement, delivery type, and intrauterine device type using log-binomial multivariable regression., Results: We identified 48 level I to II-3 studies of poor to good quality that reported a total of 7661 intrauterine device placements. Complete intrauterine device expulsion rates varied by timing of placement as follows: 10.2% (range, 0.0-26.7) for immediate; 13.2% (3.5-46.7) for early inpatient; 0% for early outpatient; and 1.8% (0.0-4.8) for interval placements. Complete intrauterine device expulsion rates also varied by delivery type: 14.8% (range, 4.8-43.1) for vaginal and 3.8% (0.0-21.1) for cesarean deliveries. Among immediate postpartum vaginal placements, the expulsion rate for levonorgetrel intrauterine devices was 27.4% (range, 18.8-45.2) and 12.4% (4.8-43.1) for copper intrauterine devices. Compared with interval placement, immediate and early postpartum placements (inpatient and outpatient combined) were associated with greater risk of complete expulsion (adjusted risk ratio, 8.33; 95% confidence interval, 4.32-16.08, and adjusted risk ratio, 5.27; 95% confidence interval, 2.56-10.85, respectively). Among immediate postpartum placements, risk of expulsion was greater for placement after vaginal compared with cesarean deliveries (adjusted risk ratio, 4.57; 95% confidence interval, 3.49-5.99). Among immediate placements at the time of vaginal delivery, levonorgestrel intrauterine devices were associated with a greater risk of expulsion compared with copper intrauterine devices (adjusted risk ratio, 1.90; 95% confidence interval, 1.36-2.65)., Conclusion: Although intrauterine device expulsion rates vary by timing of placement, type, and mode of delivery, intrauterine device insertion can take place at any time. Understanding the risk of intrauterine device expulsion at each time period will enable women to make an informed choice about when to initiate use of an intrauterine device in the postpartum period based on their own goals and preferences., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: The Zika Contraception Access Network (Z-CAN) provided women in Puerto Rico access to contraceptive counseling and the full range of reversible contraceptive methods, on the same day and at no cost, during the Zika virus outbreak. Because trained physicians and clinic staff were crucial to the program, we aimed to assess the implementation of and satisfaction with Z-CAN from their perspectives., Study Design: Physicians and clinic staff in the Z-CAN program participated in an online survey on program implementation (e.g., on-site and same-day contraceptive provision), program satisfaction, and knowledge consistent with program training (e.g., contraceptive initiation and safety, client-centered contraceptive counseling, intrauterine device [IUD] and implant insertion and removal)., Results: Survey respondents included 63 physicians and 53 clinic staff members. A high proportion of physicians (>93%) reported providing IUDs, implants, pills, rings, condoms, and injections and most were very often or always able to provide same-day access to most methods. Over 90% of physicians were satisfied with the Z-CAN program, training, and ongoing support. Staff satisfaction with these program elements was similar but slightly lower. Knowledge about exams and tests needed for initiation and safety of methods varied but was generally consistent with guidelines on which physicians received training. Most physicians (>90%) reported confidence in skills on which they received training as part of the program., Conclusions: From the perspectives of participating physicians and clinic staff, the program was generally implemented as intended and providers were largely satisfied with program strategies including training and on-going support., Implications: Certain key components of the Z-CAN program, such as training, proctoring, and involvement of clinic staff were likely critical to Z-CAN's implementation and provider satisfaction. Results from this provider survey can inform implementation of similar efforts to increase access to contraception in both emergency and non-emergency settings., (Published by Elsevier Inc.)

Background In women with congenital heart defects (CHD), changes in blood volume, heart rate, respiration, and edema during pregnancy may lead to increased risk of adverse outcomes and conditions. The American Heart Association recommends providers of pregnant women with CHD assess cardiac health and discuss risks and benefits of cardiac-related medications. We described receipt of American Heart Association-recommended cardiac evaluations, filled potentially teratogenic or fetotoxic (Food and Drug Administration pregnancy category D/X) cardiac-related prescriptions, and adverse conditions among pregnant women with CHD compared with those without CHD. Methods and Results Using 2007 to 2014 US healthcare claims data, we ascertained a retrospective cohort of women with and without CHD aged 15 to 44 years with private insurance covering prescriptions during pregnancy. CHD was defined as ≥1 inpatient code or ≥2 outpatient CHD diagnosis codes >30 days apart documented outside of pregnancy and categorized as severe or nonsevere. Log-linear regression, accounting for multiple pregnancies per woman, generated adjusted prevalence ratios (aPRs) for associations between the presence/severity of CHD and stillbirth, preterm birth, and adverse conditions from the last menstrual period to 90 days postpartum. We identified 2056 women with CHD (2334 pregnancies) and 1 374 982 women without (1 524 077 pregnancies). During the last menstrual period to 90 days postpartum, 56% of women with CHD had comprehensive echocardiograms and, during pregnancy, 4% filled potentially teratogenic or fetotoxic cardiac-related prescriptions. Women with CHD, compared with those without, experienced more adverse conditions overall (aPR, 1.9 [95% CI, 1.7-2.1]) and, specifically, obstetric (aPR, 1.3 [95% CI, 1.2-1.4]) and cardiac conditions (aPR, 10.2 [95% CI, 9.1-11.4]), stillbirth (aPR, 1.6 [95% CI, 1.1-2.4]), and preterm delivery (aPR, 1.6 [95% CI, 1.4-1.8]). More women with severe CHD, compared with nonsevere, experienced adverse conditions overall (aPR, 1.5 [95% CI, 1.2-1.9]). Conclusions Women with CHD have elevated prevalence of adverse cardiac and obstetric conditions during pregnancy; 4 in 100 used potentially teratogenic or fetotoxic medications, and only half received an American Heart Association-recommended comprehensive echocardiogram.

Tuberculosis (TB) in pregnancy poses a substantial risk of morbidity to both the pregnant woman and the fetus if not diagnosed and treated in a timely manner. Assessing the risk of having Mycobacterium tuberculosis infection is essential to determining when further evaluation should occur. Obstetrician-gynecologists are in a unique position to identify individuals with infection and facilitate further evaluation and follow up as needed. A TB evaluation consists of a TB risk assessment, medical history, physical examination, and a symptom screen; a TB test should be performed if indicated by the TB evaluation. If a pregnant woman has signs or symptoms of TB or if the test result for TB infection is positive, active TB disease must be ruled out before delivery, with a chest radiograph and other diagnostics as indicated. If active TB disease is diagnosed, it should be treated; providers must decide when treatment of latent TB infection is most beneficial. Most women will not require latent TB infection treatment while pregnant, but all require close follow up and monitoring. Treatment should be coordinated with the TB control program within the respective jurisdiction and initiated based on the woman's risk factors including social history, comorbidities (particularly human immunodeficiency virus [HIV] infection), and concomitant medications.

"U.S. Medical Eligibility Criteria for Contraceptive Use" (U.S. MEC) 2016 provides evidence-based guidance for the safe use of contraceptive methods among U.S. women with certain characteristics or medical conditions (1). The U.S. MEC is adapted from global guidance from the World Health Organization (WHO) and kept up to date through continual review of published literature (1). CDC recently evaluated the evidence and the updated WHO guidance on the risk for human immunodeficiency virus (HIV) acquisition among women using hormonal contraception and intrauterine devices (IUDs) (2). After careful review, CDC adopted WHO's 2019 updated guidance for inclusion in the U.S. MEC guidance; CDC's updated guidance states that progestin-only injectable contraception (including depot medroxyprogesterone acetate [DMPA]) and IUDs (including levonorgestrel-releasing and copper-bearing) are safe for use without restriction among women at high risk for HIV infection (U.S. MEC category 1 [previously U.S. MEC category 2, advantages outweigh risks]) (Box). CDC's guidance also adds an accompanying clarification for women who wish to use IUDs, which states "Many women at a high risk for HIV infection are also at risk for other sexually transmitted diseases (STDs). For these women, refer to the recommendations in the 'U.S. Medical Eligibility Criteria for Contraceptive Use' for women with other factors related to STDs, and the 'U.S. Selected Practice Recommendations for Contraceptive Use' on STD screening before IUD insertion" (1,3). Recommendations for other hormonal contraceptive methods (including combined hormonal methods, implants, and progestin-only pills) remain the same; there is also no restriction for their use among women at high risk for HIV infection (U.S. MEC category 1). Finally, CDC clarified that the U.S. MEC recommendations for concurrent use of hormonal contraceptives or IUDs and antiretroviral use for treatment of HIV infection also apply to use of antiretrovirals for prevention of HIV acquisition (preexposure prophylaxis [PrEP])., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

Background: The American Heart Association recommends women with congenital heart defects (CHD) receive contraceptive counseling early in their reproductive years, but little is known about contraceptive method use among women with CHD. We describe recent female sterilization and reversible prescription contraceptive method use by presence of CHD and CHD severity in 2014., Methods: Using IBM MarketScan Commercial Databases, we included women aged 15 to 44 years with prescription drug coverage in 2014 who were enrolled ≥11 months annually in employer-sponsored health plans between 2011 and 2014. CHD, CHD severity, contraceptive methods, and obstetrics-gynecology and cardiology provider encounters were identified using billing codes. We used log-binomial regression to calculate adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs) to compare contraceptive method use overall and by effectiveness tier by CHD presence and, for women with CHD, severity., Results: Recent sterilization or current reversible prescription contraceptive method use varied slightly among women with (39.2%) and without (37.3%) CHD, aPR = 1.04, 95% CI [1.01-1.07]. Women with CHD were more likely to use any Tier I method (12.9%) than women without CHD (9.3%), aPR = 1.41, 95% CI [1.33-1.50]. Women with severe, compared to non-severe, CHD were less likely to use any method, aPR = 0.85, 95% CI [0.78-0.92], or Tier I method, aPR = 0.84, 95% CI [0.70-0.99]. Approximately 60% of women with obstetrics-gynecology and <40% with cardiology encounters used any included method., Conclusions: There may be missed opportunities for providers to improve uptake of safe, effective contraceptive methods for women with CHD who wish to avoid pregnancy., (Published by Elsevier Inc.)

Objectives: We sought to examine postpartum contraceptive use among women who reported physical intimate partner violence (IPV) during or within 12 months before pregnancy compared with women who did not report physical IPV and to identify factors associated with nonuse of contraception among women who reported physical IPV., Methods: Data were obtained from women with a recent live birth from 2012 to 2015 who participated in the Pregnancy Risk Assessment and Monitoring System. We described characteristics of women and postpartum contraceptive use by method effectiveness (most effective [female sterilization, male sterilization, intrauterine device, implant], moderately effective [injectable, pill, patch, ring], less effective [condoms, natural family planning, withdrawal, other]) or no method, stratified by reported physical IPV. Multivariable logistic regression was used to examine characteristics associated with nonuse of contraception among women who reported physical IPV., Results: The proportion of women using most or moderately effective contraception was similar for women reporting and not reporting physical IPV. Less effective contraceptive use was lower among women who reported physical IPV (13.9%) than those who did not report physical IPV (25.1%) (p < .001). Nonuse was higher among women who reported physical IPV (33%) than those who did not report physical IPV (21%) (p < .001). Having no health insurance at the time of survey and experiencing traumatic stress within 12 months before delivery were associated with nonuse of contraception among women who reported physical IPV., Conclusions: The higher proportion of contraception nonuse among women who reported physical IPV indicates a potential unmet need for contraception among this vulnerable population. Recommended screening for IPV and counseling about the full range of contraceptive methods should begin during pregnancy and continue through the postpartum period., (Published by Elsevier Inc.)

Objective: As diabetes is increasing among women of reproductive age in the United States, access to effective contraception is important to allow time for optimal glycemic control which may mitigate complications in future pregnancies. This study sought to describe contraceptive use and compare the effectiveness of contraceptive methods among postpartum women with and without diabetes., Study Design: This study used data from the Pregnancy Risk Assessment Monitoring System and included women with recent live births during 2012-2015 (N = 93,574). Women were asked about pre-gestational or recent gestational diabetes and their postpartum contraceptive method. Chi-square and multivariate logistic regression analyses were used to compare contraceptive methods between women with and without diabetes., Results: Contraceptive prevalence was similar between women with (82%) and without (83%) diabetes; women with diabetes were more likely to use the most effective methods. This was driven by higher use of female sterilization among women with diabetes (15%) compared to women without diabetes (9%) (p < 0.001). In multivariate analysis, odds of use of female sterilization versus reversible prescription methods was higher among women with diabetes than women without diabetes (adjusted odds ratio 1.29, 95% confidence interval 1.19-1.39)., Conclusions: Although overall postpartum contraceptive use was high, only 1/3 of women with or without diabetes were using the most effective methods. Furthermore, women with diabetes were more likely to use female sterilization than women without diabetes. It is important all postpartum women, particularly those with high risk pregnancies such as women with diabetes, receive counseling about and access to all contraceptive methods., Implications: It is important for clinicians to counsel women with pregnancies affected by diabetes that reversible contraceptives such as implants and IUDs are as effective as female permanent contraception., (Published by Elsevier Inc.)

Objectives: Little is known about provider attitudes regarding safety of selected hormonal contraceptives among breastfeeding women., Methods: Using a nationwide survey, associations were analyzed between provider characteristics and perception of safety of combined oral contraceptives (COCs) in breastfeeding women ≥ 1 month postpartum without other venous thrombosis risk factors and depot medroxyprogesterone acetate (DMPA) in breastfeeding women < 1 month postpartum and ≥ 1 month postpartum., Results: Approximately 68% of public-sector providers considered COCs safe for breastfeeding women ≥ 1 month postpartum without other venous thrombosis risk factors, with lower odds among non-physicians versus physicians (adjusted odds ratios [aOR] range 0.34-0.51) and those with a focus on adolescent health/pediatrics versus reproductive health (aOR 0.68, 95% confidence interval [CI] 0.47-0.99). Most public-sector providers considered DMPA safe for breastfeeding women during any time postpartum, with lower odds among non-physicians versus physicians (aOR range 0.20-0.54) and those with primary clinical focus other than reproductive health (aOR range 0.26-0.65). The majority of office-based physicians considered COCs safe for breastfeeding women ≥ 1 month postpartum without other venous thrombosis risk factors, with lower odds among those who did not use, versus those who used, CDC's contraceptive guidance (aOR 0.40, 95% CI 0.21-0.77). Most office-based physicians also considered DMPA safe for breastfeeding women during any time postpartum., Conclusions for Practice: A high proportion of providers considered use of selected hormonal contraceptives safe for breastfeeding women, consistent with evidence-based guidelines. However, certain provider groups might benefit from education regarding the safety of these methods for breastfeeding women.

Background: Contraception use among postpartum women is important to prevent unintended pregnancies and optimize birth spacing. Long-acting reversible contraception, including intrauterine devices and implants, is highly effective, yet compared to less effective methods utilization rates are low., Objectives: We sought to estimate prevalence of long-acting reversible contraception use among postpartum women and examine factors associated with long-acting reversible contraception use among those using any reversible contraception., Study Design: We analyzed 2012-2015 data from the Pregnancy Risk Assessment Monitoring System, a population-based survey among women with recent live births. We included data from 37 sites that achieved the minimum overall response rate threshold for data release. We estimated the prevalence of long-acting reversible contraception use in our sample (n = 143,335). We examined maternal factors associated with long-acting reversible contraception use among women using reversible contraception (n = 97,013) using multivariable logistic regression (long-acting reversible contraception vs other type of reversible contraception) and multinomial regression (long-acting reversible contraception vs other hormonal contraception and long-acting reversible contraception vs other nonhormonal contraception)., Results: The prevalence of long-acting reversible contraception use overall was 15.3%. Among postpartum women using reversible contraception, 22.5% reported long-acting reversible contraception use, which varied by site, ranging from 11.2% in New Jersey to 37.6% in Alaska. Factors associated with postpartum long-acting reversible contraception use vs use of another reversible contraceptive method included age ≤24 years (adjusted odds ratio = 1.43; 95% confidence interval = 1.33-1.54) and ≥35 years (adjusted odds ratio = 0.87; 95% confidence interval = 0.80-0.96) vs 25-34 years; public insurance (adjusted odds ratio = 1.15; 95% confidence interval = 1.08-1.24) and no insurance (adjusted odds ratio = 0.73; 95% confidence interval = 0.55-0.96) vs private insurance at delivery; having a recent unintended pregnancy (adjusted odds ratio = 1.44; 95% confidence interval = 1.34-1.54) or being unsure about the recent pregnancy (adjusted odds ratio = 1.29; 95% confidence interval = 1.18-1.40) vs recent pregnancy intended; having ≥1 previous live birth (adjusted odds ratio = 1.40; 95% confidence interval = 1.31-1.48); and having a postpartum check-up after recent live birth (adjusted odds ratio = 2.70; 95% confidence interval = 2.35-3.11). Hispanic and non-Hispanic black postpartum women had a higher rate of long-acting reversible contraception use (26.6% and 23.4%, respectively) compared to non-Hispanic white women (21.5%), and there was significant race/ethnicity interaction with educational level., Conclusion: Nearly 1 in 6 (15.3%) postpartum women with a recent live birth and nearly 1 in 4 (22.5%) postpartum women using reversible contraception reported long-acting reversible contraception use. Our analysis suggests that factors such as age, race/ethnicity, education, insurance, parity, intendedness of recent pregnancy, and postpartum visit attendance may be associated with postpartum long-acting reversible contraception use. Ensuring all postpartum women have access to the full range of contraceptive methods, including long-acting reversible contraception, is important to prevent unintended pregnancy and optimize birth spacing. Contraceptive access may be improved by public health efforts and programs that address barriers in the postpartum period, including increasing awareness of the availability, effectiveness, and safety of long-acting reversible contraception (and other methods), as well as providing full reimbursement for contraceptive services and removal of administrative and logistical barriers., (Published by Elsevier Inc.)

Objective: Women with congenital heart disease (CHD) are at increased risk of pregnancy complications and need information on safe, effective contraceptive methods to avoid unintended pregnancy. This systematic review examines evidence regarding safety of contraceptive use among women with CHD., Methods: The PubMed database was searched for any peer-reviewed articles published through April 2018 that included safety outcomes associated with reversible contraceptive methods among women with CHD., Results: Five articles met inclusion criteria: three studies comparing contraceptive users to nonusers and two noncomparative studies. Sample sizes ranged from 65 to 505 women with CHD. Two studies found a higher percent of thromboembolic complications among women with Fontan palliation or transposition of the great arteries using oral contraceptives. One study, among women with Fontan palliation, found no increased risk of thromboembolic complications between contraceptive users (not separated by type) and nonusers. Two studies found no endocarditis among intrauterine device users., Conclusions: There is a paucity of data regarding the safety of contraceptive methods among women with CHD. Limited evidence suggests an increased incidence of thromboembolic complications with use of oral contraceptives. Further studies are needed to evaluate contraceptive safety and quantify risk in this growing population. There is also limited data regarding the safety of contraceptive methods among women with CHD. Further information is needed to assist practitioners counseling women with CHD on safety of contraceptive methods., (© 2019 Wiley Periodicals, Inc.)

Objective: To estimate the absolute and relative risk of venous thromboembolism (VTE) among women who initiate depot medroxyprogesterone acetate (DMPA) immediately postpartum compared with those who do not initiate hormonal contraception., Methods: The IBM MarketScan Commercial Claims and Encounters databases were used to identify delivery hospitalizations among women aged 15-44 years during 2005 through 2014. Diagnosis, procedure, and drug codes were used to identify contraception, VTE, and potential confounding chronic or pregnancy-related conditions. Women who initiated DMPA during days 0 through 7 postpartum were compared with women who did not initiate hormonal contraception during days 0 through 7 postpartum. Women were followed from date of delivery through 12 weeks postpartum for the occurrence of VTE, with censoring at hormonal contraception initiation or prescription, hysterectomy, sterilization, or inpatient death. The incidence rate of VTE and 95% CIs were calculated within each group and the incidence rate ratio was calculated comparing the two groups., Results: The unadjusted VTE incidence rate through 12 weeks postpartum was 0.42/10,000 women-days in the immediate postpartum DMPA group (34 events among 11,159 women contributing 805,999 days of follow-up) and 0.15/10,000 women-days in the control group (3,107 events among 3,102,011 women contributing 206,180,811 days of follow-up). The incidence rate ratio for VTE was 2.87 (95% CI 2.05-4.03) among women in the immediate postpartum DMPA group compared with women in the control group, adjusting for age alone. After adjusting for age and pregnancy-related and chronic conditions, the adjusted incidence rate ratio for VTE was 1.94 (95% CI 1.38-2.72) among women in the immediate postpartum DMPA group compared with women in the control group., Conclusion: Initiation of DMPA immediately postpartum is associated with a low incidence but an increased relative risk of VTE compared with nonuse of hormonal contraception.

Potential drug interactions with hormonal contraceptives are an important public health concern. A public meeting on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implication" was hosted by the United States Food and Drug Administration (FDA). The meeting endeavored to provide an opportunity for the FDA to seek input from experts on the public health concerns associated with the use of hormonal contraceptives and interacting drugs that might affect efficacy and safety, including pharmacokinetic/pharmacodynamic considerations, in the design of drug interaction studies of hormonal contraceptives for drug development and approaches to translating the results of drug interaction information into informative labeling and communication. The input received could be used to refine FDA's thinking on hormonal contraceptives drug interaction study design and interpretation and labeling communication of drug interaction risk. This meeting benefited from strong and diverse participation from the Center for Drug Evaluation and Research at the FDA, Centers for Disease Control and Prevention, National Institutes of Health, Swedish Medical Products Agency, pharmaceutical industry, and representatives of academia. This report provides a summary of the key discussion based on the presentations and panel discussion., (© 2018, The American College of Clinical Pharmacology.)

Objective: To estimate expulsion rates among women with postpartum intrauterine device (IUD) placement by timing of insertion, IUD type, and delivery method., Data Sources: We searched PubMed, Cochrane Library, and ClinicalTrials.gov from 1974 to May 2018., Methods of Study Selection: We searched databases for any published studies that examined postpartum placement of a copper IUD or levonorgestrel intrauterine system and reported counts of expulsions. We assessed study quality using the U.S. Preventive Services Task Force evidence grading system. We calculated pooled absolute rates of IUD expulsion and estimated adjusted relative risks (RRs) for timing of postpartum placement, delivery method, and IUD type using log-binomial multivariable regression model., Tabulation, Integration, and Results: We identified 48 level I to II-3 studies of poor to good quality. Pooled rates of expulsion varied by timing of IUD placement, ranging from 1.9% with interval placements (4 weeks postpartum or greater), 10.0% for immediate placements (10 minutes or less after placental delivery), and 29.7% for early placements (greater than 10 minutes to less than 4 weeks postpartum). Immediate and early postpartum placements were associated with increased risk of expulsion compared with interval placement (adjusted RR 7.63, 95% CI 4.31-13.51; adjusted RR 6.17, 95% CI 3.19-11.93, respectively). Postpartum placement less than 4 weeks after vaginal delivery was associated with an increased risk of expulsion compared with cesarean delivery (adjusted RR 5.19, 95% CI 3.85-6.99). Analysis of expulsion rates at less than 4 weeks postpartum also indicated that the levonorgestrel intrauterine system was associated with a higher risk of expulsion (adjusted RR 1.91, 95% CI 1.50-2.43) compared with CuT380A., Conclusion: Postpartum IUD expulsion rates vary by timing of placement, delivery method, and IUD type. These results can aid in counseling women to make an informed choice about when to initiate their IUD and to help institutions implement postpartum contraception programs.

Background: Combined oral contraceptives (COCs) containing various progestogens could be associated with differential risks for venous thromboembolism (VTE)., Objective: To evaluate the comparative risks of VTE associated with the use of low-dose (less than 50 μg ethinyl estradiol) COCs containing different progestogens., Search Strategy: PubMed and the Cochrane Library were searched from database inception through September 15, 2016, by combining search terms for oral contraception and venous thrombosis., Selection Criteria: Studies reporting VTE risk estimates among healthy users of progestogen-containing low-dose COCs were included., Data Collection and Analysis: A random-effects model was used to generate pooled adjusted risk ratios and 95% confidence intervals; subgroup and sensitivity analyses assessed the impact of monophasic-COC use and study-level characteristics., Main Results: There were 22 articles included in the analysis. The use of COCs containing cyproterone acetate, desogestrel, drospirenone, or gestodene was associated with a significantly increased risk of VTE compared with the use of levonorgestrel-containing COCs (pooled risk ratios 1.5-2.0). The analysis restricted to monophasic COC formulations with 30 μg of ethinyl estradiol yielded similar findings. After adjustment for study characteristics, the risk estimates were slightly attenuated., Conclusions: Compared with the use of levonorgestrel-containing COCs, the use of COCs containing other progestogens could be associated with a small increase in risk for VTE., (© 2018 World Health Organization; licensed by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Rationale: Data are limited regarding the safety of 12-dose once-weekly isoniazid (H, 900 mg) plus rifapentine (P, 900 mg) (3HP) for latent infection treatment during pregnancy., Objectives: To assess safety and pregnancy outcomes among pregnant women who were inadvertently exposed to study medications in two latent tuberculosis infection trials (PREVENT TB or iAdhere) evaluating 3HP and 9 months of daily isoniazid (H, 300 mg) (9H)., Methods: Data from reproductive-age (15-51 yr) women who received one or more study dose of 3HP or 9H in either trial were analyzed. Drug exposure during pregnancy occurred if the estimated date of conception was on or before the last dose date., Results: Of 126 pregnancies (125 participants) that occurred during treatment or follow-up, 87 were exposed to study drugs. Among these, fetal loss was reported for 4/31 (13%) and 8/56 (14%), 3HP and 9H, respectively (difference, 13% - 14% = -1%; 95% confidence interval = -17% to +18%) and congenital anomalies in 0/20 and 2/41 (5%) live births, 3HP and 9H, respectively (difference, 0% - 5% = -5%; 95% confidence interval = -18% to +16%). All fetal losses occurred in pregnancies of less than 20 weeks. Of the total 126 pregnancies, fetal loss was reported in 8/54 (15%) and 9/72 (13%), 3HP and 9H, respectively; and congenital anomalies in 1/37 (3%) and 2/56 (4%) live births, 3HP and 9H, respectively. The overall proportion of fetal loss (17/126 [13%]) and anomalies (3/93 [3%]) were similar to those estimated for the United States, 17% and 3%, respectively., Conclusions: Among reported pregnancies in these two latent tuberculosis infection trials, there was no unexpected fetal loss or congenital anomalies. These data offer some preliminary reassurance to clinicians and patients in circumstances when these drugs and regimens are the best option in pregnancy or in women of child-bearing potential. This work used the identifying trial registration numbers NCT00023452 and NCT01582711, corresponding to the primary clinical trials PREVENT TB and iAdhere (Tuberculosis Trials Consortium Study 26 and 33).

As women approach menopause, fertility declines but pregnancy can still occur. Maternal and infant risks are increased among women of older reproductive age compared with younger women. A high proportion of pregnancies among women of older reproductive age are unintended and these pregnancies can also be associated with negative maternal and infant consequences. However, women and their healthcare providers may have concerns about risks associated with contraceptive use, particularly combined hormonal contraceptives, among women of older reproductive age who already may be at increased risk for conditions such as cardiovascular disease and breast cancer. Nonetheless, available evidence does not suggest that hormonal contraceptive use among women of older reproductive age substantially increases age-related risks of cardiovascular events or breast cancer. CDC recommends that contraception is still needed for women older than 44 years who have not reached menopause and wish to avoid pregnancy, and that based on age alone, all contraceptive methods are considered safe or generally safe for use by women of older reproductive age.

Background: There is limited information on the patterns and trends of contraceptive use among women living with HIV, compared with noninfected women in the United States. Further, little is known about whether antiretroviral therapy correlates with contraceptive use. Such information is needed to help identify potential gaps in care and to enhance unintended pregnancy prevention efforts., Objective: We sought to compare contraceptive method use among HIV-infected and noninfected privately insured women in the United States, and to evaluate the association between antiretroviral therapy use and contraceptive method use., Study Design: We used a large US nationwide health care claims database to identify girls and women ages 15-44 years with prescription drug coverage. We used diagnosis, procedure, and National Drug Codes to assess female sterilization and reversible prescription contraception use in 2008 and 2014 among women continuously enrolled in the database during 2003 through 2008 or 2009 through 2014, respectively. Women with no codes were classified as using no method; these may have included women using nonprescription methods, such as condoms. We calculated prevalence of contraceptive use by HIV infection status, and by use of antiretroviral therapy among those with HIV. We used multivariable polytomous logistic regression to calculate unadjusted and adjusted odds ratios and 95% confidence intervals for female sterilization, long-acting reversible contraception, and short-acting hormonal contraception compared to no method., Results: While contraceptive use increased among HIV-infected and noninfected women from 2008 through 2014, in both years, a lower proportion of HIV-infected women used prescription contraceptive methods (2008: 17.5%; 2014: 28.9%, compared with noninfected women (2008: 28.8%; 2014: 39.8%, P < .001 for both). Controlling for demographics, chronic medical conditions, pregnancy history, and cohort year, HIV-infected women compared to HIV-noninfected women had lower odds of using long-acting reversible contraception (adjusted odds ratio, 0.67; 95% confidence interval, 0.52-0.86 compared to no method) or short-acting hormonal contraception method (adjusted odds ratio, 0.59; 95% confidence interval, 0.50-0.70 compared to no method). In 2014, HIV-infected women using antiretroviral therapy were significantly more likely to use no method (76.8% vs 64.1%), and significantly less likely to use short-acting hormonal contraception (11.0% vs 22.7%) compared to HIV-infected women not using antiretroviral therapy. Those receiving antiretroviral therapy had lower odds of using short-acting hormonal contraception compared to no method (adjusted odds ratio, 0.45; 95% confidence interval, 0.32-0.63). There was no significant difference in female sterilization by HIV status or antiretroviral therapy use., Conclusion: Despite the safety of reversible contraceptives for women with HIV, use of prescription contraception continues to be lower among privately insured HIV-infected women compared to noninfected women, particularly among those receiving antiretroviral therapy., (Copyright © 2017 Elsevier Inc. All rights reserved.)

CDC's U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) (first published in 2010 and updated in 2016) provides evidence-based guidance for the safe use of contraceptive methods among U.S. women with certain characteristics or medical conditions (1), and is adapted from global guidance from the World Health Organization (WHO) and kept up to date based on continual review of published literature (2).* CDC recently evaluated the evidence and the updated WHO guidance on the risk for human immunodeficiency virus (HIV) acquisition among women using hormonal contraception. † After careful review, CDC adopted the updated WHO guidance for inclusion in the U.S. MEC guidance; this guidance states that the advantages of progestin-only injectable contraceptive use (including depot medroxyprogesterone acetate [DMPA]) by women at high risk for HIV infection outweigh the theoretical or proven risks (U.S. MEC category 2). The guidance also includes an accompanying updated clarification, which states that "there continues to be evidence of a possible increased risk of acquiring HIV among progestin-only injectable users. Uncertainty exists about whether this is due to methodological issues with the evidence or a real biological effect. In many settings, unintended pregnancies and/or pregnancy-related morbidity and mortality are common, and progestin-only injectables are among the few types of methods widely available. Women should not be denied the use of progestin-only injectables because of concerns about the possible increased risk. Women considering progestin-only injectables should be advised about these concerns, about the uncertainty over whether there is a causal relationship, and about how to minimize their risk of acquiring HIV." Recommendations for other hormonal contraceptive methods (including combined hormonal methods, implants, and progestin-only pills) remain the same; there is no restriction for their use among women at high risk for HIV infection (U.S. MEC category 1).

Objective: Immediate postpartum intrauterine devices (IUDs) have been underutilized in the United States despite their known safety. Understanding how providers' attitudes contribute to underutilization is important in improving access. Our objective was to examine healthcare providers' perceptions of the safety of immediate postpartum IUDs before publication of United States contraceptive guidelines., Materials and Methods: We analyzed survey data collected from December 2009 to March 2010 from 635 office-based physicians and 1368 Title X clinic providers (overall response rate of 64.8%). Providers were asked how safe they thought copper and levonorgestrel (LNG) IUDs were in postpartum women (very safe, safe, unsafe, very unsafe, and unsure). Multivariable logistic regression was used to calculate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs) for characteristics associated with considering immediate and delayed postpartum IUDs to be safe., Results: Less than 40% of respondents considered immediate or delayed IUD insertion to be safe. Providers with <1 day of family planning training had decreased odds of considering immediate postpartum IUD insertion to be safe compared with unsafe/unsure (aOR 0.18, 95% CI 0.04-0.84 for copper IUD and aOR 0.17, 95% CI 0.04-0.81 for LNG-IUD). Providers without training in postpartum or interval copper IUD insertion had decreased odds of considering immediate postpartum copper IUD insertion (aOR 0.40, 95% CI 0.16-0.79) and delayed postpartum insertion for both IUD types to be safe (aOR 0.34, 95% CI 0.18-0.66 for copper IUD and aOR 0.41, 95% CI 0.21-0.77 for LNG-IUD)., Conclusions: Before United States contraceptive guidelines, a majority of providers perceived immediate postpartum IUDs to be unsafe.

Background: Migraine with aura and combined hormonal contraceptives are independently associated with an increased risk of ischemic stroke. However, little is known about whether there are any joint effects of migraine and hormonal contraceptives on risk of stroke., Objective: We sought to estimate the incidence of stroke in women of reproductive age and examine the association among combined hormonal contraceptive use, migraine type (with or without aura), and ischemic stroke., Study Design: This study used a nationwide health care claims database and employed a nested case-control study design. Females ages 15-49 years with first-ever stroke during 2006 through 2012 were identified using the International Classification of Diseases, Ninth Revision, Clinical Modification inpatient services diagnosis codes. Four controls were matched to each case based on age. Migraine headache with and without aura was identified using inpatient or outpatient diagnosis codes. Current combined hormonal contraceptive use was identified using the National Drug Code from the pharmacy database. Conditional logistic regression was used to estimate adjusted odds ratios and 95% confidence intervals of ischemic stroke by migraine type and combined hormonal contraceptive use., Results: From 2006 through 2012, there were 25,887 ischemic strokes among females ages 15-49 years, for a cumulative incidence of 11 strokes/100,000 females. Compared to those with neither migraine nor combined hormonal contraceptive use, the odds ratio of ischemic stroke was highest among those with migraine with aura using combined hormonal contraceptives (odds ratio, 6.1; 95% confidence interval, 3.1-12.1); odds ratios were also elevated for migraine with aura without combined hormonal contraceptive use (odds ratio, 2.7; 95% confidence interval, 1.9-3.7), migraine without aura and combined hormonal contraceptive use (odds ratio, 1.8; 95% confidence interval, 1.1-2.9), and migraine without aura without combined hormonal contraceptive use (odds ratio, 2.2; 95% confidence interval, 1.9-2.7)., Conclusion: The joint effect of combined hormonal contraceptives and migraine with aura was associated with a 6-fold increased risk of ischemic stroke compared with neither risk factor. Use of combined hormonal contraceptives did not substantially further increase risk of ischemic stroke among women with migraine without aura. Determining migraine type is critical in assessing safety of combined hormonal contraceptives among women with migraine., (Published by Elsevier Inc.)

Objective: To summarize published evidence on drug interactions between hormonal contraceptives and antiretrovirals., Design: Systematic review of the published literature., Methods: We searched PubMed, POPLINE, and EMBASE for peer-reviewed publications of studies (in any language) from inception to 21 September 2015. We included studies of women using hormonal contraceptives and antiretrovirals concurrently. Outcomes of interest were effectiveness of either therapy, toxicity, or pharmacokinetics. We used standard abstraction forms to summarize and assess strengths and weaknesses., Results: Fifty reports from 46 studies were included. Most antiretrovirals whether used for therapy or prevention, have limited interactions with hormonal contraceptive methods, with the exception of efavirenz. Although depot medroxyprogesterone acetate is not affected, limited data on implants and combined oral contraceptive pills suggest that efavirenz-containing combination antiretroviral therapy may compromise contraceptive effectiveness of these methods. However, implants remain very effective despite such drug interactions. Antiretroviral plasma concentrations and effectiveness are generally not affected by hormonal contraceptives., Conclusion: Women taking antiretrovirals, for treatment or prevention, should not be denied access to the full range of hormonal contraceptive options, but should be counseled on the expected rates of unplanned pregnancy associated with all contraceptive methods, in order to make their own informed choices.

Background: Combined hormonal contraceptives (CHCs), containing estrogen and progestin, are associated with an increased risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE) compared with nonuse. Few studies have examined whether nonoral formulations (including the combined hormonal patch, combined vaginal ring and combined injectable contraceptives) increase the risk of thrombosis compared with combined oral contraceptives (COCs)., Objectives: The objectives were to examine the risk of VTE and ATE among women using nonoral CHCs compared to women using COCs., Methods: We searched the PubMed database for all English language articles published from database inception through May 2016. We included primary research studies that examined women using the patch, ring or combined injectables compared with women using levonorgestrel-containing or norgestimate-containing COCs. Outcomes of interest included VTE (deep venous thrombosis or pulmonary embolism) or ATE (acute myocardial infarction or ischemic stroke). We assessed the quality of each individual piece of evidence using the system developed by the United States Preventive Services Task Force., Results: Eight studies were identified that met inclusion criteria. Of seven analyses from six studies examining VTE among patch users compared with levonorgestrel- or norgestimate-containing COC users, two found a statistically significantly elevated risk among patch users (risk estimates 2.2-2.3), one found an elevated risk that did not meet statistical significance (risk estimate 2.0), and four found no increased risk. Of three studies examining VTE among ring users compared with levonorgestrel COC users, one found a statistically significantly elevated risk among patch users (risk estimate 1.9) and two did not. Two studies did not find an increased risk for ATE among women using the patch compared with norgestimate COCs. We did not identify any studies examining combined injectable contraceptives., Conclusion: Limited Level II-2 good to fair evidence demonstrated conflicting results on whether women using the patch or the ring have a higher risk of VTE than women using COCs. Evidence did not demonstrate an increased risk of ATE among women using the patch. Overall, any potential elevated risk likely represents a small number of events on a population level. Additional studies with standard methodology are needed to further clarify any associations and better understand mechanisms of hormone-induced thrombosis among users of nonoral combined hormonal contraception., (Published by Elsevier Inc.)

Background: Women with medical conditions associated with increased risk for thrombosis generally should not use estrogen-containing contraceptives; however, less is known about progestin-only contraceptives (POCs) and thrombosis risk., Objectives: The objective was to identify evidence regarding the risk of venous thromboembolism (VTE) or arterial thromboembolism [stroke or acute myocardial infarction (AMI)] among women using POCs., Methods: We searched the PubMed database for all articles published from database inception through January 2016 for studies examining thrombosis among women using POCs. We included studies which examined women with medical conditions associated with thrombosis risk, as well as studies of women in the general population (either without these conditions or who were not specified to have these conditions). Hormonal contraceptives of interest included progestin-only pills (POPs), injectables, implants and levonorgestrel-releasing intrauterine devices (LNG-IUDs). Outcomes of interest included VTE, stroke and AMI., Results: There were 26 articles of good to poor quality that met inclusion criteria; 9 studies examined women with medical conditions and 20 examined women in the general population. Two studies found that, among smokers and women with certain thrombogenic mutations, use of depot medroxyprogesterone acetate (DMPA) had elevated odds of VTE compared with nonsmokers or those without mutations, although confidence intervals were wide and overlapped with odds among nonusers. One study found that, among women with previous VTE, use of POCs (including DMPA) was associated with a nonsignificant increased odds of recurrent VTE (all of which were among DMPA users); two other studies that examined POCs other than DMPA did not observe an association with recurrent VTE. Two studies found that use of DMPA among healthy women was also associated with increased odds of VTE. Two studies found that use of POCs for therapeutic indications was associated with increased odds of VTE. Studies did not find increased odds of VTE with POPs for contraceptive purposes, implants or LNG-IUDs nor were there increased odds of stroke or AMI with any POCs., Conclusion: The majority of evidence identified by this systematic review did not suggest an increase in odds for venous or arterial events with use of most POCs. Limited evidence suggested increased odds of VTE with use of injectables (three studies) and use of POCs for therapeutic indications (two studies, one with POCs unspecified and the other with POPs). Any increase in risk likely translates to a small increase in absolute numbers of thrombotic events at the population level., (Published by Elsevier Inc.)

Objectives: To investigate levonorgestrel (LNG)-releasing and copper-bearing (Cu) intrauterine device (IUD) safety among breastfeeding women and, for Cu-IUD use, breastfeeding performance and infant health., Study Design: Systematic review., Methods: We searched PubMed, Embase, Cochrane Library and clinicaltrials.gov for articles through January 2016. We included studies of Cu-IUD or LNG-IUD users comparing IUD-specific (perforation, expulsion) and other contraceptive-related (infection, removal/cessation due to bleeding/pain and other adverse events) outcomes for breastfeeding vs. non-breastfeeding women. We also included studies of breastfeeding women comparing contraceptive-related outcome for IUD-users vs. other contraceptive-method users. Finally, we included studies comparing breastfeeding outcomes among Cu-IUD users to users of other nonhormonal contraceptives or no contraception., Results: Of 548 articles identified, 23 (16 studies) met the inclusion criteria. Two studies suggested that the risk of IUD perforation was 6-10 times higher among breastfeeding vs. non-breastfeeding women. Seven studies suggested that risks for other adverse events were similar or lower among breastfeeding vs. non-breastfeeding women. Three studies among breastfeeding women found no increased risk of adverse events in IUD users vs. nonusers. Breastfeeding performance and infant growth were similar for Cu-IUD users and users of other nonhormonal methods or no contraception., Conclusion: Overall, risks for adverse events among IUD users, including expulsion, pain and removals, were similar or lower for breastfeeding women vs. non-breastfeeding women. Uterine perforation with IUDs, while rare, appeared more frequent among breastfeeding women. No evidence indicated that Cu-IUD use in breastfeeding women influences breastfeeding performance or infant growth., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Migraine is common among women of reproductive age and is associated with an increased risk of ischemic stroke. Combined oral contraceptives (COCs) are also associated with an increased risk of ischemic stroke. Use of hormonal contraception among women with migraine might further elevate the risk of stroke among women of reproductive age., Objective: To identify evidence regarding the risk of arterial thromboembolism (stroke or myocardial infarction) among women with migraine who use hormonal contraceptives., Methods: We searched the PubMed database for all articles published from database inception through January 2016. We included studies that examined women with migraine overall or separated by subtype (with or without aura). Hormonal contraceptives of interest included combined hormonal methods (COCs, patch and ring) and progestin-only methods (progestin-only pills, injectables, implants and progestin intrauterine devices)., Results: Seven articles met inclusion criteria. All were case-control studies of fair to poor quality reporting on use of COCs or oral contraceptives (OCs) not further described and all reported stroke outcomes. Four studies demonstrated that, among women with migraine (not separated by subtype), COC use was associated with approximately two to four times the risk of stroke compared with nonuse. The only study to examine specific migraine subtypes found an elevated risk of stroke among women with migraine with aura, and this risk was similar regardless of OC use, although these odds ratios were not reported. Two studies did not report risks among women with migraine and COC use combined, but both found increased risks of stroke with migraine and COC use independently. No evidence was found on other hormonal contraceptives or on risk of myocardial infarction., Conclusion: Limited evidence suggests a two- to fourfold increased risk of stroke among women with migraine who use COCs compared with nonuse. Additional study is needed on the risks of hormonal contraceptives, including combined and progestin-only methods, among women with different migraine subtypes., (Published by Elsevier Inc.)

Objective: To examine whether the co-administration of hormonal contraceptives (HC) and psychotropic drugs commonly used to treat anxiety and/or depression results in safety or efficacy concerns for either drug., Methods: We searched PubMed and Cochrane libraries for clinical or pharmacokinetic (PK) studies that examined co-administration of any HC with psychotropic drugs [selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), oral benzodiazepines, bupropion, mirtazapine, trazadone, buspirone, hydroxyzine, monoamine oxidase inhibitors (MAOIs), or atypical antipsychotics] in reproductive aged women., Results: Of 555 articles identified, 22 articles (18 studies) met inclusion criteria. We identified 5 studies on SSRIs, four on TCAs, one on bupropion, three on atypical antipsychotics and five on oral benzodiazepines. No articles met inclusion criteria for SNRIs, mirtazapine, trazadone, buspirone, hydroxyzine or MAOIs. Overall, clinical studies did not demonstrate differences in unintended pregnancy rates when HCs were administered with and without psychotropic drugs or in psychotropic drug treatment outcomes when psychotropic drugs were administered with and without HCs. PK studies did not demonstrate changes in drug exposure related to contraceptive safety, contraceptive effectiveness or psychotropic drug effectiveness for most classes of psychotropic drugs. However, limited PK data raise concern for HCs increasing systemic exposure of amitriptyline and imipramine (both TCAs), theoretically posing safety concerns., Conclusion: Limited quality and quantity evidence on use of psychotropic drugs and HCs suggests low concern for clinically significant interactions, though no data exist specifically for non-oral formulations of HC. Given the high frequency of use for both HCs and psychotropic drugs among reproductive-age women in the US, this review highlights a need for further research in this area., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: St. John's wort (SJW) is a known strong inducer of the cytochrome P450 (CYP) 3 A4 enzyme, and both the ethinyl estradiol and progestin components of hormonal contraceptives are substrates of CYP3A4. This systematic review examined whether the co-administration of SJW and hormonal contraceptives leads to significant safety or efficacy concerns., Study Design: Systematic review., Methods: PubMed and Cochrane Library databases were searched for articles of any comparative study design (clinical or pharmacokinetic) that examined potential interactions between SJW and hormonal contraceptives in women of reproductive age., Results: Of the 48 identified articles, four studies met inclusion criteria and compared use of combined oral contraceptives (COCs) alone to the use of COCs co-administered with SJW. Two studies demonstrated no change in markers of ovulation, but one study demonstrated increased follicular growth and probable ovulation when COCs were co-administered with SJW. Three studies demonstrated an increased risk of breakthrough bleeding with COCs and SJW. Three studies showed changes in at least one pharmacokinetic parameter that suggested a significantly decreased exposure to hormone concentrations when COCs were co-administered with SJW. The only study that did not demonstrate any significant pharmacokinetic differences examined a SJW product containing a low amount of hypericin., Conclusion: Limited evidence showing increased risk of ovulation and breakthrough bleeding raises concern for decreased contraceptive efficacy when COCs are co-administered with SJW. The pharmacokinetic evidence is mixed but suggests that SJW administration may be associated with weak to moderate induction of the metabolism of COCs., (Copyright © 2016 Elsevier Inc. All rights reserved.)