Public health priorities for gastroschisis: Summary of a meeting sponsored by the Centers for Disease Control and Prevention and the March of Dimes.

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.

Abnormal uterine bleeding diagnoses and care following COVID-19 vaccination.

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.

Postmenopausal bleeding after COVID-19 vaccination.

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.

Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023.

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.

Reproductive Health of Women with Congenital Heart Defects.

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.

Case Series of Thrombosis With Thrombocytopenia Syndrome After COVID-19 Vaccination-United States, December 2020 to August 2021.

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.

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021.

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.

Venlafaxine prescription claims among insured women of reproductive age and pregnant women, 2011-2016.

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.

Required examinations and tests before initiating contraception: Provider practices from a national cross-sectional survey.

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.

Evaluating the Association of Stillbirths After Maternal Vaccination in the Vaccine Safety Datalink.

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.

Adverse Pregnancy Conditions Among Privately Insured Women With and Without Congenital Heart Defects.

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 in Pregnancy.

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.

Update to U.S. Medical Eligibility Criteria for Contraceptive Use, 2016: Updated Recommendations for the Use of Contraception Among Women at High Risk for HIV Infection.

"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]).

Physician and clinic staff attitudes and practices during implementation of the Zika Contraception Access Network.

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.

Expulsion of intrauterine devices after postpartum placement by timing of placement, delivery type, and intrauterine device type: a systematic review and meta-analysis.

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.

Contraceptive methods of privately insured US women with congenital heart defects.

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.

Intimate Partner Violence around the Time of Pregnancy and Postpartum Contraceptive Use.

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.

Description and comparison of postpartum use of effective contraception among women with and without diabetes.

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.

Health Care Provider Attitudes Toward Safety of Selected Hormonal Contraceptives in Breastfeeding Women.

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.