Understanding the Impacts of the Supreme Court Case FDA v Alliance for Hippocratic Medicine.

This Viewpoint outlines the potential effects of the Supreme Court case regarding mifepristone restrictions: a decision for the FDA would allow current dispensing, while ruling against the FDA would severely curtail access to reproductive health options.

Implementation of pharmacy access to hormonal contraception.

BACKGROUND: States throughout the country are enacting legislation to authorize pharmacist prescribing of hormonal contraception to decrease barriers to access. Little is known about the process of state implementation of pharmacist prescriptive authority for hormonal contraception. OBJECTIVES: To understand the state-level steps to enable pharmacist prescribing of hormonal contraception, including implementation challenges and facilitators. METHODS: We conducted a qualitative study of interviews with 18 key individuals, including pharmacists and other stakeholders, from ten states with laws permitting pharmacist-prescribed hormonal contraception from March 2021 to April 2022. We analyzed data using directed qualitative analysis principles and compared experiences across states. We organized the data using the Consolidated Framework for Implementation Research framework and evaluated relevant constructs in states' implementation efforts. RESULTS: Participants identified four key steps to implement pharmacist prescribing at the state level, including development of state rules and regulations, educational programs, reimbursement mechanisms, and expansion strategies to pharmacists and pharmacies. Participants identified early involvement of key stakeholders and a culture of support for clinical pharmacists as facilitators to implementation. Challenges included complexity and cost of billing mechanisms, lack of funding for implementation efforts, and competing priorities of pharmacies/pharmacists. CONCLUSION: Participants in states with pharmacist prescriptive authority for hormonal contraception identified development of reimbursement and billing mechanisms as the most critical state-level step in implementation. Focusing on facilitators of key steps can guide states in developing successful implementation strategies to improve contraceptive access.

Medication Abortion Follow-Up Rates in a Rural Population Before and After Introduction of a Remote Follow-Up Option.

Background: Medication abortion (MAB) follow-up historically involves visiting a health care facility for ultrasonography or laboratory testing. In rural states such as New Mexico, many patients travel hours for MAB, making two visits burdensome. Studies demonstrate feasibility, safety, and patient preference for remote follow-up. Materials and Methods: We evaluated whether MAB follow-up by telephone had noninferior loss-to-follow-up (LTFU) rates compared with ultrasonography or laboratory follow-up in a rural population. This was a retrospective chart review of University of New Mexico MAB LTFU rates after changing to telephone follow-up (home group, n = 136). Patients were propensity-matched in a 1:2 ratio to a historical cohort (health care group, n = 272) to eliminate significant differences. We defined LTFU as no contact within 50 days. We evaluated complications requiring intervention, possible ongoing pregnancy, completion of the home follow-up protocol (7- and 30-day calls, high-sensitivity urine pregnancy test [UPT]), follow-up by intended method (home or health care), and number of call attempts. Results: LTFU rates for the home group (n = 23, 17%) were noninferior to the health care group (n = 60, 22%, p = 0.24). Rates of complications requiring intervention (p = 0.83) and possible ongoing pregnancy (p = 0.72) among the home group were similar to the health care group. Ninety-seven (71%) home group patients completed the initial call, 79 (58%) completed the UPT, and 86 (69%) completed the 30-day call. Ninety-five (70%) home group patients followed up by intended method, comparable with the health care group (n = 199, 73%, p = 0.56). Staff made a median of 3 (interquartile range: 2-4) calls per home group patient. Conclusions: Remote MAB LTFU rates were noninferior to in-person LTFU rates.

Prenatal Contraceptive Counseling.

Pregnancy care should include open discussions with patients about their ideal family size and pregnancy spacing. With these patient-voiced goals in mind, clinicians should review contraceptive tools to meet these goals, including special considerations after birth. For patients that desire contraception, it is important to prioritize the provision of their chosen method as soon as safely possible and desired after birth.

Early vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial.

Importance: The early postpartum period, 2 to 4 weeks after birth, may be a convenient time for intrauterine device (IUD) placement; the placement could then coincide with early postpartum or well-baby visits. Objective: To determine expulsion rates for IUDs placed early postpartum compared with those placed at the standard interval 6-week visit. Design, Setting, and Participants: In this randomized noninferiority trial, people who had a vaginal or cesarean birth were randomly assigned to undergo early (14-28 days) or interval (42-56 days) postpartum IUD placement. Clinicians blinded to participant study group used transvaginal ultrasonography to confirm IUD presence and position at the 6-month postpartum follow-up. The study assessed 642 postpartum people from 4 US medical centers, enrolled a consecutive sample of 404 participants from March 2018 to July 2021, and followed up each participant for 6 months postpartum. Interventions: Early postpartum IUD placement, at 2 to 4 weeks postpartum, vs standard interval placement 6 to 8 weeks postpartum. Main Outcomes and Measures: The primary outcome was complete IUD expulsion by 6 months postpartum; the prespecified noninferiority margin was 6%. Secondary outcomes were partial IUD expulsion, IUD removal, pelvic infection, patient satisfaction, uterine perforation, pregnancy, and IUD use at 6 months postpartum. IUD malposition was an exploratory outcome. Results: Among 404 enrolled participants, 203 participants were randomly assigned to undergo early IUD placement and 201 to undergo interval IUD placement (mean [SD] age, 29.9 [5.4] years; 46 [11.4%] were Black, 228 [56.4%] were White, and 175 [43.3%] were Hispanic). By 6 months postpartum, 53 participants (13%) never had an IUD placed and 57 (14%) were lost to follow-up. Among the 294 participants (73%) who received an IUD and completed 6-month follow-up, complete expulsion rates were 3 of 149 (2.0% [95% CI, 0.4%-5.8%]) in the early placement group and 0 of 145 (0% [95% CI, 0.0%-2.5%]) in the interval placement group (between-group difference, 2.0 [95% CI, -0.5 to 5.7] percentage points). Partial expulsion occurred in 14 (9.4% [95% CI, 5.2%-15.3%]) participants in the early placement group and 11 (7.6% [95% CI, 3.9%-13.2%]) participants in the interval placement group (between-group difference, 1.8 [95% CI, -4.8 to 8.6] percentage points). IUD use at 6 months was similar between the groups: 141 (69.5% [95% CI, 62.6%-75.7%]) participants in the early group vs 139 (67.2% [95% CI, 60.2%-73.6%]) in the interval group. Conclusions and Relevance: Early IUD placement at 2 to 4 weeks postpartum compared with 6 to 8 weeks postpartum was noninferior for complete expulsion, but not partial expulsion. Understanding the risk of expulsion at these time points may help patients and clinicians make informed choices about the timing of IUD placement. Trial Registration: ClinicalTrials.gov Identifier: NCT03462758.

Out-of-State Travel for Abortion among Texas Residents following an Executive Order Suspending In-State Services during the Coronavirus Pandemic.

During the COVID-19 pandemic, existing and new abortion restrictions constrained people's access to abortion care. We assessed Texas abortion patients' out-of-state travel patterns before and during implementation of a state executive order that prohibited most abortions for 30 days in 2020. We received data on Texans who obtained abortions between February and May 2020 at 25 facilities in six nearby states. We estimated weekly trends in the number of out-of-state abortions related to the order using segmented regression models. We compared the distribution of out-of-state abortions by county-level economic deprivation and distance traveled. The number of Texas out-of-state abortions increased 14% the week after (versus before) the order was implemented (incidence rate ratio [IRR] = 1.14; 95% CI: 0.49, 2.63), and increased weekly while the order remained in effect (IRR = 1.64; 95% CI: 1.23, 2.18). Residents of the most economically disadvantaged counties accounted for 52% and 12% of out-of-state abortions before and during the order, respectively (p < 0.001). Before the order, 38% of Texans traveled ≥250 miles one way, whereas during the order 81% traveled ≥250 miles (p < 0.001). Texans' long-distance travel for out-of-state abortion care and the socioeconomic composition of those less likely to travel reflect potential burdens imposed by future abortion bans.

Association of Texas' 2021 Ban on Abortion in Early Pregnancy With the Number of Facility-Based Abortions in Texas and Surrounding States.

Importance: Texas' 2021 ban on abortion in early pregnancy may demonstrate how patterns of abortion might change following the US Supreme Court's June 2022 decision overturning Roe v Wade. Objective: To assess changes in the number of abortions and changes in the percentage of out-of-state abortions among Texas residents performed at 12 or more weeks of gestation in the first 6 months following implementation of Texas Senate Bill 8 (SB 8), which prohibited abortions after detection of embryonic cardiac activity. Design, Setting, and Participants: Retrospective study of a sample of 50 Texas and out-of-state abortion facilities using an interrupted time series analysis to assess changes in the number of abortions, and Poisson regression to assess changes in abortions at 12 or more weeks of gestation. Data included 68 820 Texas facility-based abortions and 11 287 out-of-state abortions among Texas residents during the study period from September 1, 2020, to February 28, 2022. Exposures: Abortion care obtained after (September 2021-February 2022) vs before (September 2020-August 2021) implementation of SB 8. Main Outcomes and Measures: Primary outcomes were changes in the number of facility-based abortions for Texas residents, in Texas and out of state, in the month after implementation of SB 8 compared with the month before. The secondary outcome was the change in the percentage of out-of-state abortions among Texas residents obtained at 12 or more weeks of gestation during the 6-month period after the law's implementation. Results: Between September 2020 and August 2021, there were 55 018 abortions in Texas and 2547 out-of-state abortions among Texas residents. During the 6 months after SB 8, there were 13 802 abortions in Texas and 8740 out-of-state abortions among Texas residents. Compared with the month before implementation of SB 8, the number of Texas facility-based abortions significantly decreased from 5451 to 2169 (difference, -3282 [95% CI, -3171 to -3396]; incidence rate ratio [IRR], 0.43 [95% CI, 0.36-0.51]) in the month after SB 8 was implemented. The number of out-of-state abortions among Texas residents significantly increased from 222 to 1332 (difference, 1110 [95% CI, 1047-1177]; IRR, 5.38 [95% CI, 4.19-6.91]). Overall, the total documented number of Texas facility-based and out-of-state abortions among Texas residents significantly decreased from 5673 to 3501 (absolute change, -2172 [95% CI, -2083 to -2265]; IRR, 0.67 [95% CI, 0.56-0.79]) in the first month after SB 8 was implemented compared with the previous month. Out-of-state abortions among Texas residents obtained at 12 or more weeks of gestation increased from 17.1% (221/1291) to 31.0% (399/1289) (difference, 178 [95% CI, 153-206]) during the period between September 2021 and February 2022 (P < .001 for trend). Conclusions and Relevance: Among a sample of abortion facilities, the 2021 Texas law banning abortion in early pregnancy (SB 8) was significantly associated with a decrease in the documented total of facility-based abortions in Texas and obtained by Texas residents in surrounding states in the first month after implementation compared with the previous month. Over the 6 months following SB 8 implementation, the percentage of out-of-state abortions among Texas residents obtained at 12 or more weeks of gestation significantly increased.

An initiative to implement immediate postpartum long-acting reversible contraception in rural New Mexico.

BACKGROUND: Over the past decade, many states have developed approaches to reimburse for immediate postpartum long-acting reversible contraception. Despite expanded coverage, few hospitals offer immediate postpartum long-acting reversible contraception. OBJECTIVES: Immediate postpartum long-acting reversible contraception implementation is complex and requires a committed multidisciplinary team. After New Mexico Medicaid approved reimbursement for this service, the New Mexico Perinatal Collaborative developed and initiated an evidence-based implementation program containing several components. We sought to evaluate timing of the implementation process and facilitators and barriers to immediate postpartum long-acting reversible contraception in several New Mexico rural hospitals. The primary study outcome was time from New Mexico Perinatal Collaborative program component introduction in each hospital to the hospital's completion of the corresponding implementation step. Secondary outcomes included barriers and facilitators to immediate postpartum contraception implementation. STUDY DESIGN: In this mixed-methods study, conducted from April 2017 to May 2018, we completed semistructured questionnaires and interviews with 20 key personnel from 7 New Mexico hospitals that planned to implement immediate postpartum long-acting reversible contraception. The New Mexico Perinatal Collaborative introduced program components to hospitals in a stepped-wedge design. Participants contributed baseline and follow-up data at 4 time periods detailing the steps taken towards program implementation and the timing of step completion at their hospital. Qualitative data were analyzed using directed qualitative content analysis principles based on the Consolidated Framework for Implementation Research. RESULTS: Investigators conducted 43 interviews during the 14-month study period. Median time to complete steps toward implementation-patient education, clinician training, nursing education, charge capture, available supplies, and protocols or guidelines-ranged from 7 days for clinician training to 357 days to develop patient education materials. Facilitators of immediate postpartum contraception readiness were local hospital clinical champions and institutional administrative and financial stability. Of the 7 hospitals, 4 completed all Perinatal Collaborative implementation program components and 3 of those piloted immediate postpartum long-acting reversible contraception services. Two publicly funded hospitals currently offer immediate postpartum long-acting reversible contraception without verification of payment for the device or insertion. The third hospital piloted the program with 8 contraceptive devices, did not receive reimbursement due to identified flaws in Medicaid billing guidance and does not currently offer the service. The remaining 3 of the 7 hospitals declined to complete the NMPC program; the hospital that completed the program but did not pilot immediate postpartum long-acting reversible contraception did so because Medicaid billing mechanisms were incompatible with their automated billing systems. Participants consistently reported that lack of reimbursement was the major barrier to immediate postpartum long-acting reversible contraception implementation. CONCLUSION: Despite the New Mexico Perinatal Collaborative's robust implementation process and hospital engagement, most hospitals did not offer immediate postpartum long-acting reversible contraception over the study period. Reimbursement obstacles prevented full service implementation. Interventions to improve immediate postpartum long-acting reversible contraception access must begin with implementation of seamless billing and reimbursement mechanisms to ensure adequate hospital payments.

Barriers and Solutions to Improve Adolescent Intrauterine Device Access.

Professional organizations agree that adolescents are good candidates for intrauterine device (IUD) use. The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists affirm that IUDs should be considered first-line as contraceptive methods for adolescents. Although the number of teens using IUDs is growing, multiple barriers remain, including systems, and patient- and provider-level obstacles. Only through concerted efforts and a committed action plan will adolescents achieve better access to IUDs.

Patient satisfaction and wait times following outpatient manual vacuum aspiration compared to electric vacuum aspiration in the operating room: a cross-sectional study.

BACKGROUND: Outpatient manual vacuum aspiration (MVA) is a safe and equally effective alternative to electric vacuum aspiration (EVA) in the operating room. This project was conducted to determine whether outpatient MVA expedites care while maintaining patient satisfaction. METHODS: A cross-sectional study of a convenience sample of patients undergoing surgical management of spontaneous abortion, induced abortion, or retained products of conception with either outpatient MVA under local anesthesia or EVA in the operating room was conducted. Of 138 women completing surveys, 48 (34.8%) underwent outpatient MVA and 90 (65.2%) underwent EVA in the operating room. Procedure length, time from decision to procedure, and patient satisfaction were assessed through a self-administered questionnaire completed post-procedure. RESULTS: Most (77%) patients in the MVA group reported waiting fewer than 2 h from the time of their decision to the procedure, while most (74%) EVA patients reported waiting over 12 h (P < 0.001); the MVA group reported higher satisfaction with time to procedure (P = 0.02). The median procedure length was significantly shorter in the EVA group (10 vs. 20 min, P < 0.001). There was no significant difference between groups in overall satisfaction with the procedure (P = 0.16). CONCLUSION: Outpatient MVA under local anesthesia is a suitable alternative to operating room-based EVA for management of spontaneous abortion, induced abortion, and retained products of conception. Outpatient MVA is associated with shorter decision-to-procedure time and is highly acceptable to patients. Integration of outpatient MVA into clinical settings can add time- and resource-saving options for uterine evacuation while maintaining a positive patient experience.

Geographic Comparison of Women in Academic Obstetrics and Gynecology Department-Based Leadership Roles.

OBJECTIVE: To describe and compare geographic representation of women in obstetrics and gynecology department-based leadership roles across American Congress of Obstetricians and Gynecologists (ACOG) districts and U.S. Census Bureau regions while accounting for the proportion of women practicing in each area. METHODS: We conducted a cross-sectional observational study. To more meaningfully quantify representation of women as leaders in ACOG districts and U.S. Census Bureau regions, we calculated representation ratios-the proportion of department-based leaders who were women divided by the proportion of obstetrician-gynecologists who were women. A ratio of 1.0 indicates proportionate representation and less than 1.0 indicates underrepresentation. We calculated 95% CIs to compare representation of women in leadership roles across geographic areas. The gender of major department-based leaders (chair, vice chair, division director) and educational leaders (fellowship, residency, associate residency, medical student clerkship director) was determined from websites. RESULTS: The proportion of department chairs who were women was highest in the West and lowest in the South Census Bureau regions. Representation ratios for women in major department-based leadership roles demonstrated underrepresentation relative to the practicing base nationally and in all four regions. Although women were underrepresented in major department-based leadership throughout the country, there was significantly higher women's representation in major department-based leadership roles in the West (ratio 0.82, 95% CI 0.68-0.99) compared with the Northeast (ratio 0.50, 95% CI 0.42-0.59) and the South (ratio 0.45, 95% CI 0.36-0.57). Similarly, in the division director role, the West (ratio 0.85, 95% CI 0.68-1.1) had significantly higher representation of women compared with the Northeast (ratio 0.50, 95% CI 0.40-0.62). Nationally, women were underrepresented as fellowship directors, proportionately represented as residency program directors, and overrepresented as medical student clerkship directors. CONCLUSION: Representation ratios of women in major department-based leadership roles, which account for the proportion of women practicing in each geographic area, suggest that women were more likely to advance to the department-based leadership roles of chair, vice chair, or division director in the western United States.

Continuation of copper and levonorgestrel intrauterine devices: a retrospective cohort study.

BACKGROUND: Studies conflict on whether the duration of use of the copper intrauterine device is longer than that of the levonorgestrel intrauterine device, and whether women who continue using intrauterine devices differ from those who discontinue. OBJECTIVE: We sought to assess continuation rates and performance of levonorgestrel intrauterine devices compared with copper intrauterine devices over a 5-year period. STUDY DESIGN: We performed a retrospective cohort study of 1164 individuals who underwent intrauterine device placement at an urban academic medical center. The analysis focused on a comparison of continuation rates between those using levonorgestrel intrauterine device and copper intrauterine device, factors associated with discontinuation, and intrauterine device performance. We assessed the differences in continuation at discrete time points, pregnancy, and expulsion rates using χ2 tests and calculated hazard ratios using a multivariable Cox model. RESULTS: Of 1164 women who underwent contraceptive intrauterine device insertion, 956 had follow-up data available. At 2 years, 64.9% of levonorgestrel intrauterine device users continued their device, compared with 57.7% of copper intrauterine device users (P = .11). At 4 years, continuation rates were 45.1% for levonorgestrel intrauterine device and 32.6% for copper intrauterine device (P < .01), and at 5 years continuation rates were 28.1% for levonorgestrel intrauterine device and 23.8% for copper intrauterine device (P = .33). Black race, primiparity, and age were positively associated with discontinuation; education was not. The hazard ratio for discontinuation of levonorgestrel intrauterine device compared with copper intrauterine device >4 years was 0.71 (95% confidence interval, 0.55-0.93) and >5 years was 0.82 (95% confidence interval, 0.64-1.05) after adjusting for race, age, parity, and education. Copper intrauterine device users were more likely to experience expulsion (10.2% copper intrauterine device vs 4.9% levonorgestrel intrauterine device, P < .01) over the study period and to become pregnant in the first year of use (1.6% copper intrauterine device vs 0.1% levonorgestrel intrauterine device, P < .01). CONCLUSION: We found a difference in continuation rates between levonorgestrel and copper intrauterine device users at 4 years but not at 5 years. Copper intrauterine device users were more likely to experience expulsion and pregnancy.

Implementing Immediate Postpartum Long-Acting Reversible Contraception Programs.

OBJECTIVE: To understand the most important steps required to implement immediate postpartum long-acting reversible contraception (LARC) programs in different Georgia hospitals and the barriers to implementing such a program. METHODS: This was a qualitative study. We interviewed 32 key personnel from 10 Georgia hospitals working to establish immediate postpartum LARC programs. Data were analyzed using directed qualitative content analysis principles. We used the Stages of Implementation to organize participant-identified key steps for immediate postpartum LARC into an implementation guide. We compared this guide to hospitals' implementation experiences. RESULTS: At the completion of the study, LARC was available for immediate postpartum placement at 7 of 10 study hospitals. Participants identified common themes for the implementation experience: team member identification and ongoing communication, payer preparedness challenges, interdependent department-specific tasks, and piloting with continuing improvements. Participants expressed a need for anticipatory guidance throughout the process. Key first steps to immediate postpartum LARC program implementation were identifying project champions, creating an implementation team that included all relevant departments, obtaining financial reassurance, and ensuring hospital administration awareness of the project. Potential barriers included lack of knowledge about immediate postpartum LARC, financial concerns, and competing clinical and administrative priorities. Hospitals that were successful at implementing immediate postpartum LARC programs did so by prioritizing clear communication and multidisciplinary teamwork. Although the implementation guide reflects a comprehensive assessment of the steps to implementing immediate postpartum LARC programs, not all hospitals required every step to succeed. CONCLUSION: Hospital teams report that implementing immediate postpartum LARC programs involves multiple departments and a number of important steps to consider. A stage-based approach to implementation, and a standardized guide detailing these steps, may provide the necessary structure for the complex process of implementing immediate postpartum LARC programs in the hospital setting.

Comparison of Women in Department Leadership in Obstetrics and Gynecology With Those in Other Specialties.

OBJECTIVE: To compare the representation of women in obstetrics and gynecology department-based leadership to other clinical specialties while accounting for proportions of women in historical residency cohorts. METHODS: This was a cross-sectional observational study. The gender of department-based leaders (chair, vice chair, division director) and residency program directors was determined from websites of 950 academic departments of anesthesiology, diagnostic radiology, general surgery, internal medicine, neurology, obstetrics and gynecology, pathology, pediatrics, and psychiatry. Each specialty's representation ratio-proportion of leadership roles held by women in 2013 divided by proportion of residents in 1990 who were women-and 95% confidence interval (CI) were calculated. A ratio of 1 indicates proportionate representation. RESULTS: Women were significantly underrepresented among chairs for all specialties (ratios 0.60 or less, P≤.02) and division directors for all specialties except anesthesiology (ratio 1.13, 95% CI 0.87-1.46) and diagnostic radiology (ratio 0.97, 95% CI 0.81-1.16). The representation ratio for vice chair was below 1.0 for all specialties except anesthesiology; this finding reached statistical significance only for pathology, pediatrics, and psychiatry. Women were significantly overrepresented as residency program directors in general surgery, anesthesiology, obstetrics and gynecology, and pediatrics (ratios greater than 1.19, P≤.046). Obstetrics and gynecology and pediatrics had the highest proportions of residents in 1990 and department leaders in 2013 who were women. CONCLUSION: Despite having the largest proportion of leaders who were women, representation ratios demonstrate obstetrics and gynecology is behind other specialties in progression of women to departmental leadership. Women's overrepresentation as residency program directors raises concern because education-based academic tracks may not lead to major leadership roles.