Abortion Restrictions Threaten Miscarriage Management In The United States.

Miscarriage and abortion require similar clinical management. Restrictions placed on abortion threaten the quality of miscarriage care, a policy spillover that affects many Americans. We combined vital statistics with life-table parameters to estimate that 1,034,000 miscarriages occur annually, including nearly 400,000 in US states with abortion bans. Attempts to restrict mifepristone access further threaten miscarriage management.

Abortion Stigma as a Barrier to Mifepristone Use among Obstetrician-Gynecologists in Alabama for Early Pregnancy Loss.

OBJECTIVES: The objective of our study was to identify and characterize barriers to mifepristone use among obstetrician-gynecologists (OB-GYNs) for early pregnancy loss in a southern US state. METHODS: In this qualitative study, we conducted semistructured interviews with 19 OB-GYNs in Alabama who manage early pregnancy loss. The interviews explored participants' knowledge of and experience with mifepristone use for miscarriage management and abortion, along with barriers to and facilitators of clinical mifepristone use. The interviews were coded by multiple study staff using inductive and deductive thematic coding. RESULTS: Nearly all of the interviewees identified abortion-related stigma as a barrier to mifepristone use. Interviewees often attributed stigma to a lack of knowledge about the clinical use of mifepristone for early pregnancy loss. The stigmatization of mifepristone due to its association with abortion was related to religious and political objections. Many interviewees also described stigma associated with misoprostol use. Although providers believed that mifepristone use for abortion would not be accepted in their practice, most believed that mifepristone could be used successfully for miscarriage management after practice-wide education on its use. CONCLUSIONS: Mifepristone is strongly associated with abortion stigma among OB-GYNs in Alabama, which is a barrier to its use for miscarriage management. Interventions to decrease abortion stigma and associated stigma surrounding mifepristone are needed to optimize early pregnancy loss care.

First dose of misoprostol administration at home or in hospital for medical abortion between 12-22 gestational weeks in Sweden (PRIMA): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Medical abortion after 12 gestational weeks often requires a stay in hospital. We hypothesised that administering the first misoprostol dose at home could increase day-care procedures as compared with overnight care procedures, shorten inpatient stays, and improve patient satisfaction. METHODS: This multicentre, open-label, randomised controlled trial was done at six hospitals in Sweden. Participants were pregnant people aged 18 years and older who were undergoing medical abortion at 85-153 days of pregnancy. Randomisation was done in blocks 1:1 to mifepristone administered in-clinic followed by home administration or hospital administration of the first dose of misoprostol. Allocation was done by opening of opaque allocation envelopes. Due to the nature of the intervention, masking was not feasible. Between 24-48 h after mifepristone 200 mg, the participants administered 800 µg of misoprostol either at home 2 h before admission to hospital or in hospital. The primary outcome was the proportion of day-care procedures (defined as abortion completed in <9 h). The intention-to-treat analysis included all participants randomly assigned to receive the study drug and who had known results for the primary outcome. Individuals who received any treatment were included in the safety analyses. This trial is registered at ClinicalTrials.gov, NTC03600857, and EudraCT, 2018-000964-27. FINDINGS: Between Jan 8, 2019, and Dec 21, 2022, 457 participants were randomly assigned to treatment groups. In the intention-to-treat-population, 220 participants were assigned to the home group and 215 to the hospital group. In the home group, 156 (71%) of 220 participants completed the abortion as day-care patients, compared with 99 (46%) of 215 in the hospital group (difference 24·9%, 95% CI 15·4-34·3; p<0·0001). In total, 97 (22%) of 444 participants in the safety analysis had an adverse event. Seven (2%) of 444 participants aborted after mifepristone only. Two (1%) of 220 in the home group aborted after the first dose of misoprostol, before hospital admission. INTERPRETATION: Home administration of misoprostol significantly increases the proportion of day-care procedures in medical abortion after 12 gestational weeks, offering a safe and effective alternative to in-clinic protocols. FUNDING: Region Västra Götaland, Hjalmar Svensson's Fund, the Gothenburg Society of Medicine, Karolinska Institutet-Region Stockholm, and The Swedish Research Council.

Support for Mail-Order Pharmacy Dispensing of Mifepristone for Medication Abortion.

According to this study.

The Success of Mifepristone and Misoprostol in the Management of Early Pregnancy Loss at a Community Hospital: A Prospective Study.

OBJECTIVES: This prospective single-arm study was conducted to understand the expulsion rate of the gestational sac in the management of early pregnancy loss (EPL). METHODS: We recruited 441 participants; 188 met the eligibility criteria. Participants were 18 years of age and older who experienced a confirmed EPL (<12 weeks gestational age) defined by an intrauterine pregnancy with a non-viable embryonic or anembryonic gestational sac with no fetal heart activity. Participants were given 200 mg of mifepristone pre-treatment orally followed by 2 doses of misoprostol 800 µg vaginally after 24 and 48 hours. Participants were seen in follow-up on day 14 to confirm the absence of a gestational sac, classified as treatment success. For failed treatment (defined by retained gestational sac), we offered expectant management or a third dose of misoprostol and/or dilatation and curettage. We followed all participants for 30 days. We collected data on overtreatment for retained products of conception and hospital admissions for adverse events. RESULTS: Overall, 181 participants followed the protocol and 169 (93.3%) participants had a complete expulsion of the gestational sac by the second visit (day 14). Twelve (6.6%) failed the treatment and 1 had an adverse event of heavy vaginal bleeding requiring dilatation and curettage. Despite the expulsion of the gestational sac, 29 cases (17.1%) at subsequent follow-up were diagnosed as retained products of conception based on ultrasound assessment of thickened endometrium. CONCLUSIONS: Pretreatment with mifepristone followed by 2 doses of misoprostol with a 14-day follow-up resulted in a high expulsion rate and is a safe management option for EPL.

Risk of teratogenicity in continued pregnancy after gestational exposure to mifepristone and/or misoprostol: a systematic review and meta-analysis.

PURPOSE: This meta-analysis aimed to comprehensively assess the teratogenic risk to offspring associated with continuing pregnancy after administering mifepristone and/or misoprostol during gestation. METHODS: We conducted a systematic search of multiple databases, including PubMed, Web of Science, Embase, Cochrane, CNKI, and CBM, from their inception to February 2024, with no language restrictions. We included cohort and case-control studies that analyzed the teratogenic effects of mifepristone and/or misoprostol on fetuses and newborns. Quality assessment was performed using the Newcastle-Ottawa Scale (NOS). The odds ratios (OR) from individual studies were combined using meta-analysis. Sensitivity testing and heterogeneity analysis were conducted. RESULTS: A total of 13 studies were eligible for inclusion, comprising 5193 cases of congenital malformations and 12,232 controls. CONCLUSION: Our findings indicated that the use of misoprostol during early pregnancy increased the risk of congenital abnormalities in offspring (OR = 2.69; 95% CI: 1.57-4.62). However, the potential teratogenic effect of mifepristone during pregnancy cannot be ruled out. Additionally, the use of mifepristone and/or misoprostol has been linked to a higher risk of certain congenital anomalies, such as hydrocephalus (OR = 3.41; 95% CI: 1.17-9.97), Möbius syndrome (OR = 26.48; 95% CI: 11.30-62.01), and terminal transverse limb defects (OR = 10.75; 95% CI: 3.93-29.41). (PROSPERO, CRD42024522093, 03182024).

Food and Drug Administration v Alliance for Hippocratic Medicine-A Cautious Win for Reproductive Health Care and FDA Authority.

This Viewpoint discusses the recent US Supreme Court ruling allowing mifepristone­a drug used in medication abortion­to be widely available in the US, summarizes the history of challenges to the availability of mifepristone, and highlights reasons for concerns that remain after the Court's current ruling.

Checks and Balances on FDA's Authority.

In this Viewpoint, the authors refute recent suggestions that the US Food and Drug Administration (FDA) is not accountable for its decisions, pointing out the legal, legislative, and executive checks and balances on the agency.

Primary Care's Role in Prescribing Mail-Order Mifepristone.

This Viewpoint discusses the controversy over mail-order mifepristone prescribed by primary care clinicians for first-trimester abortion as it relates to the history of initial approval, the Supreme Court case Alliance for Hippocratic Medicine v US Food and Drug Administration, and available clinical research.

Mail-Order Pharmacy Dispensing of Mifepristone for Medication Abortion After In-Person Screening.

Importance: Before 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion. Objective: To estimate the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy. Design, Setting, and Participants: This prospective cohort study was conducted from January 2020 to May 2022 and included 11 clinics in 7 states (5 abortion clinics and 6 primary care sites, 4 of which were new to abortion provision). Eligible participants were seeking medication abortion at 63 or fewer days' gestation, spoke English or Spanish, were age 15 years or older, and were willing to take misoprostol buccally. After assessing eligibility for medication abortion through an in-person screening, mifepristone and misoprostol were prescribed using a mail-order pharmacy. Patients had standard follow-up care with the clinic. Clinical information was collected from medical records. Consenting participants completed online surveys about their experiences 3 and 14 days after enrolling. A total of 540 participants were enrolled; 10 withdrew or did not take medication. Data were analyzed from August 2022 to December 2023. Intervention: Mifepristone, 200 mg, and misoprostol, 800 µg, prescribed to a mail-order pharmacy and mailed to participants instead of dispensed in person. Main Outcomes and Measures: Proportion of patients with a complete abortion with medications only, reporting satisfaction with the medication abortion, and reporting timely delivery of medications. Results: Clinical outcome information was obtained and analyzed for 510 abortions (96.2%) among 506 participants (median [IQR] age, 27 [23-31] years; 506 [100%] female; 194 [38.3%] Black, 88 [17.4%] Hispanic, 141 [27.9%] White, and 45 [8.9%] multiracial/other individuals). Of these, 436 participants (85.5%; 95% CI, 82.2%-88.4%) received medications within 3 days. Complete abortion occurred after medication use in 499 cases (97.8%; 95% CI, 96.2%-98.9%). There were 24 adverse events (4.7%) for which care was sought for medication abortion symptoms; 3 patients (0.6%; 95% CI, 0.1%-1.7%) experienced serious adverse events requiring hospitalization (1 with blood transfusion); however, no adverse events were associated with mail-order dispensing. Of 477 participants, 431 (90.4%; 95% CI, 87.3%-92.9%) indicated that they would use mail-order dispensing again for abortion care, and 435 participants (91.2%; 95% CI, 88.3%-93.6%) reported satisfaction with the medication abortion. Findings were similar to those of other published studies of medication abortion with in-person dispensing. Conclusions and Relevance: The findings of this cohort study indicate that mail-order pharmacy dispensing of mifepristone for medication abortion was effective, acceptable to patients, and feasible, with a low prevalence of serious adverse events. This care model should be expanded to improve access to medication abortion services.

Availability of mifepristone and misoprostol in Oregon pharmacies: A comparison by rural and urban status.

OBJECTIVES: To evaluate the availability of mifepristone and misoprostol at pharmacies in a state with protective abortion legislation and variation in access by rurality. STUDY DESIGN: Using a secret shopper survey, researchers attempted to contact all community pharmacies in Oregon and evaluate their mifepristone and misoprostol provisions. RESULTS: Among the 444 pharmacies surveyed, mifepristone was planned at 19.2%. Misoprostol was available at 77.5%, but stocking issues and medication ordering impact access, without significant differences by rurality. CONCLUSIONS: Pharmacy engagement and support are key to increasing access to these essential medicines, which may be improved through education and referral programs.

24-Hour Compared With 12-Hour Mifepristone-Misoprostol Interval for Second-Trimester Abortion: A Randomized Controlled Trial.

OBJECTIVE: To compare 24-hour and 12-hour mifepristone-to-misoprostol intervals for second-trimester medication abortion. METHODS: We conducted a prospective randomized controlled trial. Participants were allocated to receive mifepristone either 24 hours or 12 hours before misoprostol administration. The primary outcome was the time from the first misoprostol administration to abortion (induction time). Secondary outcomes included the time from mifepristone to abortion (total abortion time); fetal expulsion percentages at 12, 24, and 48 hours after the first misoprostol dose; side effects proportion; and pain and satisfaction scores. A sample size of 40 per group (N=80) was planned to compare the 24- and 12-hour regimens. RESULTS: Eighty patients were enrolled between July 2020 and June 2023, with 40 patients per group. Baseline characteristics were comparable between groups. Median induction time was 9.5 hours (95% CI, 10.3-17.8 hours) and 12.5 hours (95% CI, 13.5-20.2 hours) in the 24- and 12-hour interval arms, respectively ( P =.028). Median total abortion time was 33.0 hours (95% CI, 34.2-41.9 hours) and 24.5 hours (95% CI, 25.7-32.4 hours) in the 24- and 12-hour interval groups, respectively ( P <.001). At 12 hours from misoprostol administration, 25 patients (62.5%) in the 24-hour arm and 18 patients (45.0%) in the 12-hour arm completed abortion ( P =.178). At 24 hours from misoprostol administration, 36 patients (90.0%) in the 24-hour arm and 30 patients (75.0%) in the 12-hour arm had complete abortion ( P =.139). The need for additional medication or surgical treatment for uterine evacuation, pain scores, side effects, and satisfaction levels were not different between groups. CONCLUSION: A 24-hour mifepristone-to-misoprostol regimen for medication abortion in the second trimester provides a median 3-hour shorter induction time compared with the 12-hour interval. However, the median total abortion time was 8.5-hours longer in the 24-hour interval regimen. These findings can aid in shared decision making before medication abortion in the second trimester. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04160221.

What's at stake for science in 'abortion pill' case.

Supreme Court decision this summer could gut FDA's authority over drugs.