RESUMEN
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.
Asunto(s)
Abortivos no Esteroideos , Aborto Inducido , Mifepristona , Misoprostol , Humanos , Misoprostol/administración & dosificación , Femenino , Embarazo , Adulto , Suecia , Aborto Inducido/métodos , Abortivos no Esteroideos/administración & dosificación , Mifepristona/administración & dosificación , Satisfacción del Paciente , Adulto Joven , Hospitalización/estadística & datos numéricos , Primer Trimestre del Embarazo , Tiempo de Internación/estadística & datos numéricos , Abortivos Esteroideos/administración & dosificaciónRESUMEN
BACKGROUND: International guidelines recommend placement of intrauterine devices immediately after second-trimester medical abortion, but evidence concerning the optimal time for intrauterine device placement is lacking from clinical trials. OBJECTIVE: This study aimed to investigate effectiveness, safety, and acceptability of intrauterine device placement within 48 hours, compared with placement at 2 to 4 weeks after second-trimester medical abortion. We hypothesized that intrauterine device placement within 48 hours would be superior compared with placement at 2 to 4 weeks after the abortion, in terms of the proportion of intrauterine device use after 6 months, with maintained safety and acceptability. STUDY DESIGN: In this open-label, randomized, controlled, superiority trial, we recruited participants at 8 abortion clinics in Sweden. Eligible participants were aged ≥18 years, requesting medical abortion with gestation ≥85 days, and opting for use of a postabortion intrauterine device. Participants were randomized (1:1) to intrauterine device placement either within 48 hours of complete abortion (intervention) or after 2 to 4 weeks (control). Our primary outcome was self-reported use of an intrauterine device after 6 months. Secondary outcomes included expulsion rates, pain at placement, adverse events and complications, acceptability, and subsequent pregnancies and abortions. Differences in nonnormal continuous variables were analyzed with the Mann-Whitney U test, and differences in dichotomous variables with the chi-square or Fisher exact tests. A P value <.05 was considered statistically significant. Group differences are presented by modified intention-to-treat and per-protocol analyses. RESULTS: Between January 2019 and June 2022, we enrolled 179 participants, of whom 90 were assigned to the intervention and 89 to the control arm. Enrollment was prematurely stopped after an interim analysis exceeded a predefined intrauterine device expulsion rate of 20%. According to modified intention-to-treat analysis, use of intrauterine device after 6 months was 50.7% (34/67) in the intervention group vs 71.6% (48/67) in the control group (proportion difference, 20.9%; 95% confidence interval, 4.4%-35.9%; P=.02). The intrauterine device expulsion rate was 30.1% (22/73) in the intervention group vs 2.9% (2/70; P<.001) in the control group. Other adverse events were rare and patient acceptability was high in both groups. CONCLUSION: Intrauterine device placement within 48 hours after second-trimester medical abortion was nonsuperior in terms of the proportion of intrauterine device use after 6 months when compared with placement after 2 to 4 weeks. Placement within 48 hours after second-trimester abortion can be used in selected individuals after counseling on expulsion risk.
RESUMEN
INTRODUCTION: Although considered an essential service by the WHO, there are indications that access to induced abortion care has been restricted during the COVID-19 pandemic. OBJECTIVES: To investigate if the number of induced abortions and ongoing pregnancies changed during the first pandemic wave of COVID-19 in 2020 compared with recent years prior to the pandemic and explore possible reasons for the findings. DESIGN: Convergent parallel mixed-methods design. Collection of quantitative data from the Swedish National Board of Health and Welfare and the Swedish Pregnancy Register, and qualitative data from interviews. SETTING AND TIME PERIOD: National data on abortions (January 2018-June 2020) and births (January 2018-March 2021). Interviews performed at the main abortion clinic, Gothenburg, Sweden, in June 2020. PARTICIPANTS: All women aged 15-44 years living in Sweden 2018-2020, approximately 1.9 million. 15 women who sought abortion were interviewed. PRIMARY AND SECONDARY OUTCOME MEASURES: Number of abortions and births/1000 women aged 15-44 years. Themes and subthemes identified from interviews. RESULTS: The number of abortions and ongoing pregnancies did not change significantly during the study period compared with before the pandemic started. Interview themes identified were the following: meeting with abortion care during the COVID-19 pandemic (availability, and fear of being infected and infecting others); and the impact of the COVID-19 pandemic on the abortion decision (to catch COVID-19 during pregnancy, feelings of loneliness and isolation, and social aspects). CONCLUSIONS: This study shows that the number of abortions and ongoing pregnancies remained unchanged during the first wave of the COVID-19 pandemic in 2020 in Sweden compared with before the start of the pandemic. Abortion-seeking women did not hesitate to proceed with the abortion. The women expressed a number of fears concerning both availability of care and their health, which could have been properly addressed by the authorities.