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ObjectiveTo develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials.Study designWe extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale. After 2 rounds, we used descriptive analyses to determine which outcomes met the predefined consensus criteria. We finalized the core outcome set during a series of consensus development meetings.ResultsWe entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 invitees (87%) provided responses (203 complete responses) for round 1 and 118 of 218 (42%) completed round2. Sixteen experts participated in the development meetings. The final outcome set includes 15 outcomes: 10 outcomes apply to all abortion trials (successful abortion, ongoing pregnancy, death, hemorrhage, uterine infection, hospitalization, surgical intervention, pain, gastrointestinal symptoms, and patients' experience of abortion); 2 outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and 2 apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity).ConclusionUsing robust consensus science methods we have developed a core outcome set for future abortion research.ImplicationsStandardized outcomes in abortion research could decrease heterogeneity among trials and improve the quality of systematic reviews and clinical guidelines. Researchers should select, collect, and report these core outcomes in future abortion trials. Journal editors should advocate for core outcome set reporting.

AbstractPurposeMethodsResultsConclusions\nSHORT CONDENSATIONTo evaluate the feasibility and acceptability of outpatient medical induction at 13-18 weeks’ gestation to limit overnight hospital stays.In this prospective cohort study, participants with 13-18-week pregnancies seeking abortions at two government hospitals swallowed mifepristone 200 mg and self-administered misoprostol 400 mcg buccally 24-48 h later, 1-2 h before returning to the outpatient clinic (OPD). Repeat misoprostol was dosed every 3 h until expulsion. Participants requiring care beyond OPD hours were admitted as inpatients. Acceptability was evaluated by exit interview before discharge. Participants were contacted two weeks later to assess any subsequent issues.Ninety-eight (82%) of 120 participants had successful outpatient abortions using a median two (IQR 2, 3) misoprostol doses. The median induction-to-abortion time was five hours (IQR 4, 7.5). Eleven (9%) participants expelled before clinic arrival. Twenty-two (18%) participants were transferred as inpatients at OPD closing. Transferred participants remained inpatient for a median 18 h (IQR 18, 21.25). There were no serious adverse events and satisfaction with the abortion process was high.Although the outpatient model did not meet statistical expectations, it is clinically feasible, acceptable, and improves efficiency, expands access, and reduces burdens for women and providers. Operational adjustments may facilitate higher outpatient success.Outpatient medical induction at 13-18 weeks’ gestation is feasible, improves efficiency, expands access, reduces staff and patient burdens, and aligns guidelines and practice with evidence. [ABSTRACT FROM AUTHOR]

Background: Early first-trimester medical abortion (MA) service (≤ 63 days) has been provided by doctors and nurses under doctors’ supervision since 2009 in Nepal. This paper assesses whether MA services provided by specifically trained and certified nurses and auxiliary nurse-midwives independently from doctors’ supervision, is considered as satisfactory by women as those provided by doctors. Methods: The data come from a multi-center, randomized, controlled equivalence trial conducted between April 2009 and March 2010 in five district hospitals in Nepal. Women seeking MA were randomly assigned to doctors or nurses and auxiliary nurse-midwives(ANMs).Eligible women were administered 200 mg mifepristone orally followed by 800 μg misoprostol vaginally two days later by their assigned providers and followed up 10–14 days later. At the follow-up visit women’s reported satisfaction with MA service they received was measured. Results: Of 1295 women screened for eligibility, 535 were randomly assigned to a doctor and 542 to a nurse or ANM. Nineteen women were lost-to-follow up in the former group and 27 were lost-to-follow up or did not complete the acceptability interview in the latter group. This study is, therefore, based on516womenin the doctor’s group and 515 women in the nurse or ANM group. All women in the nurse or ANM group reported being satisfied or highly satisfied by MA compared to 99% in the doctor’s group. Satisfaction was similar regardless of the type of provider; 38% among nurse or ANM and 35% among the doctor group were “highly satisfied”, and 62% and 64%, respectively, were “satisfied”. Women’s experiences such as ‘less than expected amount or duration of bleeding following MA’, ‘shorter than expected duration of the abortion process’, and ‘able to manage symptoms’, were found to be associated with women’s higher satisfaction with MA. Counseling and information on the method, potential complications of MA and post-abortion contraception was nearly universal. No statistically significant differences were found in the level of satisfaction by age, parity, marital status, education or occupation of women. Conclusions: Women’s satisfaction with MA service provided by trained nurses or auxiliary nurse-midwives was similar to that provided by doctors. The findings, therefore, provide support for extending safe and accessible medical abortion services by government-trained nurses and auxiliary nurse midwives to women seeking early first trimester pregnancy termination. Trial registration The trial was retrospectively registered with ClinicalTrials.gov (identifier: NCT01186302). Registered August 20, 2010.

BACKGROUND Medication abortion, with a combination of mifepristone and misoprostol, is highly effective and safe. However, there is insufficient evidence on efficacy and safety at very early gestations before a pregnancy can be visualized with ultrasonography. METHODS We conducted a multicenter, noninferiority, randomized, controlled trial involving women requesting medication abortion at up to 42 days of gestation with an unconfirmed intrauterine pregnancy on ultrasound examination (visualized as an empty cavity or a sac-like structure without a yolk sac or embryonic pole). Participants were randomly assigned to either immediate start of abortion (early-start group) or standard-care treatment delayed until intrauterine pregnancy was confirmed (standard group). The primary outcome was complete abortion. The noninferiority margin was set at 3.0 percentage points for the absolute between-group difference. RESULTS In total, 1504 women were included at 26 sites in nine countries and were randomly assigned to the early-start group (754 participants) or the standard group (750 participants). In an intention-to-treat analysis, a complete abortion occurred in 676 of 710 participants (95.2%) in the early-start group and in 656 of 688 (95.3%) in the standard group; the absolute between-group difference was -0.1 percentage points (95% confidence interval, -2.4 to 2.1). Ectopic pregnancies occurred in 10 of 741 participants (1.3%) in the early-start group and in 6 of 724 (0.8%) in the standard group, with one rupture before diagnosis (early-start group). Serious adverse events occurred in 12 of 737 participants (1.6%) in the early-start group and in 5 of 718 (0.7%) in the standard group (P = 0.10); the majority were uncomplicated hospitalizations for treatment of ectopic pregnancy or incomplete abortion. CONCLUSIONS Medication abortion before confirmed intrauterine pregnancy was noninferior to standard, delayed treatment with respect to complete abortion. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the safety, acceptability and feasibility of a one-day outpatient medication abortion service at gestations 13-18 weeks.Study Design: Open-label prospective study in which participants received mifepristone 200 mg orally to swallow at home or at the clinic followed 24 h later by misoprostol 400 mcg buccally. They presented to the outpatient clinic 24-48 h after mifepristone for misoprostol 400 mcg buccally every three hours (no maximum dose). The primary outcome was successful abortion without transfer to overnight inpatient care. Secondary outcomes included time to abortion from initial misoprostol dose, safety, additional interventions and side effects.Results: We enrolled 230 women from December 2017 to November 2018. Approximately nine of ten (n = 206, 89.6%) achieved a successful abortion without transfer to overnight care. Twenty-four were transferred to overnight inpatient care; of these 18 were to manage a complication, five for incomplete abortion and two by choice. Among these 24, three women experienced an SAE. The median time to successful abortion from time of the first misoprostol dose was 7.2 h (range: 0.75-92.3), with an average of three misoprostol doses. Most participants expelled the fetus and the placenta at or around the same time; median time between fetal and placental expulsion was 15 minutes (range: 0-4.5 h). Fifteen participants (6.6%) received more than five misoprostol doses and were transferred to inpatient care. Administration of more than five doses of misoprostol was associated with nulliparity. Provision of antibiotics (27.9%, n = 64), manual removal of placenta (15.3%, n = 35), uterotonics (4.4%, n = 10) and surgical interventions (4.4%, n = 10) were also reported. About one in four participants experienced nausea, vomiting and chills; fever was infrequent (2.5%, n = 5).Conclusions: For gestations 13-18 weeks, an outpatient day process for medication abortion is safe, effective and feasible.Implications: Medication abortion in 13 - 18 weeks need not be limited to inpatient care; nine of ten cases can be managed as an outpatient day service. [ABSTRACT FROM AUTHOR]

Objective: To examine incidence of child marriage among displaced and host populations in humanitarian settings., Design: Cross-sectional surveys., Setting: Data were collected in Djibouti, Yemen, Lebanon and Iraq in the Middle East and in Bangladesh and Nepal in South Asia., Participants: Adolescent girls aged 10-19 in the six settings and age cohort comparators., Outcome Measures: Cumulative incidence of marriage by age 18., Results: In Bangladesh and Iraq, the hazard of child marriage did not differ between internally displaced populations (IDPs) and hosts (p value=0.25 and 0.081, respectively). In Yemen, IDPs had a higher hazard of child marriage compared with hosts (p value<0.001). In Djibouti, refugees had a lower hazard of child marriage compared with hosts (p value<0.001). In pooled data, the average hazard of child marriage was significantly higher among displaced compared with host populations (adjusted HR (aHR) 1.3; 95% CI 1.04 to 1.61).In age cohort comparisons, there was no significant difference between child marriage hazard across age cohorts in Bangladesh (p value=0.446), while in Lebanon and Nepal, younger cohorts were less likely to transition to child marriage compared with older comparators (p value<0.001). Only in Yemen were younger cohorts more likely to transition to child marriage, indicating an increase in child marriage rates after conflict (p value=0.034). Pooled data showed a downward trend, where younger age cohorts had, on average, a lower hazard of child marriage compared with older cohorts (aHR 0.36; 95% CI 0.29 to 0.4)., Conclusions: We did not find conclusive evidence that humanitarian crises are associated with universal increases in child marriage rates. Our findings indicate that decision-making about investments in child marriage prevention and response must be attuned to the local context and grounded in data on past and current trends in child marriage among communities impacted by crisis., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)