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.

No test medical abortion - a review of the evidence on selective use of preabortion testing.

PURPOSE OF REVIEW: The last decade has seen a cascade of different telemedicine models for medical abortion (MA) being tested and implemented. Among these service delivery models is the 'no-test' MA model, in which care is provided remotely and eligibility for the MA is based on history alone. The purpose of this review is to provide an overview of the existing evidence for no-test MA. RECENT FINDINGS: The evidence base for no-test MA relies heavily on cohort and noncomparative studies predominantly from high resource settings. Recent findings indicate that no-test MA is safe, effective, and highly acceptable. Diagnoses of ectopic pregnancy and underestimation of gestational age were rare. Identified advantages included shortening time to access MA and mitigating access barriers such as cost, and geographical barriers. Abortion seekers valued omitting the ultrasound citing reasons such as privacy concerns, costs, more flexibility, and control. The impacts of no-test MA on unscheduled postabortion contacts and visits and on contraceptive use were unclear due to limited evidence. SUMMARY: No-test MA can be provided to complement other care pathways including those with some or no in-person care. Further research is needed to allow for widespread adoption of no-test MA and scale-up in a variety of contexts, including low-resource settings.

Medical Abortion before Confirmed Intrauterine Pregnancy: A Systematic Review.

"Very early medical abortion" (VEMA) refers to medical abortion (with mifepristone and misoprostol) before intrauterine pregnancy is visualized on ultrasound. Our aim is to present the current evidence on efficacy, safety (focused on ectopic pregnancies), and how to assess treatment success of VEMA. We conducted a systematic review of studies reporting outcomes of VEMA. The field is small and so our objective was to map all relevant literature, without conducting meta-analysis. We searched PubMed, Medline, and Embase on April 19, 2022. We conducted a narrative synthesis of the evidence. A total of 373 articles were identified. Six articles (representing four observational and one pilot trial) were included in the final review. Across all included studies, treatment efficacy ranged between 91 and 100%. Prevalence of ectopic pregnancy was low and very few cases (n = 2) of ruptures were reported. Most studies used serial serum human chorionic gonadotrophin (s-hCG) levels to determine success of abortion; one study used low sensitivity urine hCG. From the available evidence, VEMA appears to be efficacious and does not appear to cause harm to ectopic pregnancies. Treatment can be assessed with pre- and postabortion s-hCG. Good quality, randomized controlled trial evidence is needed to best inform practice.

Telemedicine as an alternative way to access abortion in Italy and characteristics of requests during the COVID-19 pandemic.

INTRODUCTION: Induced abortion is legal in Italy but with restrictions. The online abortion provider Women on Web (WoW) serves as an alternative way to access abortion. The COVID-19 pandemic has affected sexual and reproductive health worldwide. Italy was one of the first countries hit by the pandemic and imposed strict lockdown measures. We aimed to understand why women requested WoW abortion in Italy and how this was affected by the pandemic. METHODS: We conducted an observational study analysing requests made to WoW before and during the pandemic. We analysed 778 requests for medical abortion from Italy between 1 March 2019 to 30 November 2020 and compared the characteristics of requests submitted before and during the pandemic. We also performed subgroup analysis on teenagers and COVID-19-specific requests. RESULTS: There was an increase in requests during the COVID-19 pandemic compared with the previous year (12% in the first 9 months). The most common reasons for requesting a telemedicine abortion through WoW were privacy-related (40.9%); however, this shifted to COVID-19-specific (50.3%) reasons during the pandemic. Requests from teenagers (n=61) were more frequently made at later gestational stages (p=0.003), had a higher prevalence of rape (p=0.003) as the cause of unwanted pregnancies, and exhibited less access to healthcare services compared with adult women. CONCLUSIONS: There was an increase in total demand for self-managed abortion during the pandemic and reasons for requesting an abortion changed, shifting from privacy-related to COVID-19-specific reasons. This study also highlighted the uniquely vulnerable situation of teenagers with unwanted pregnancies seeking self-managed abortion.