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Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians: a randomised controlled equivalence trial in a low-resource setting in Kenya.

ABSTRACT: OBJECTIVE:To assess the effectiveness of midwives administering misoprostol to women with incomplete abortion seeking post-abortion care (PAC), compared with physicians. DESIGN:A multicentre randomised controlled equivalence trial. The study was not masked. SETTINGS:Gynaecological departments in two hospitals in a low-resource setting, Kenya. POPULATION:Women (n=1094) with incomplete abortion in the first trimester, seeking PAC between 1 June 2013 to 31 May 2016. Participants were randomly assigned to receive treatment from midwives or physicians. 409 and 401 women in the midwife and physician groups, respectively, were included in the per-protocol analysis. INTERVENTIONS:600?µg misoprostol orally, and contraceptive counselling by a physician or midwife. MAIN OUTCOME MEASURES:Complete abortion not needing surgical intervention within 7-10 days. The main outcome was analysed on the per-protocol population with a generalised estimating equation model. The predefined equivalence range was -4% to 4%. Secondary outcomes were analysed descriptively. RESULTS:The proportion of complete abortion was 94.8% (768/810): 390 (95.4%) in the midwife group and 378 (94.3%) in the physician group. The proportion of incomplete abortion was 5.2% (42/810), similarly distributed between midwives and physicians. The model-based risk difference for midwives versus physicians was 1.0% (-4.1 to 2.2). Most women felt safe (97%; 779/799), and 93% (748/801) perceived the treatment as expected/easier than expected. After contraceptive counselling the uptake of a contraceptive method after 7-10 days occurred in 76% (613/810). No serious adverse events were recorded. CONCLUSIONS:Treatment of incomplete abortion with misoprostol provided by midwives is equally effective, safe and accepted by women as when administered by physicians in a low-resource setting. Systematically provided contraceptive counselling in PAC is effective to mitigate unmet need for contraception. TRIAL REGISTRATION NUMBER:NCT01865136; Results.

SUBMITTER: Makenzius M

PROVIDER: S-EPMC5652492 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians: a randomised controlled equivalence trial in a low-resource setting in Kenya.

Makenzius Marlene M Oguttu Monica M Klingberg-Allvin Marie M Gemzell-Danielsson Kristina K Odero Theresa M A TMA Faxelid Elisabeth E

BMJ open 20171010 10

<h4>Objective</h4>To assess the effectiveness of midwives administering misoprostol to women with incomplete abortion seeking post-abortion care (PAC), compared with physicians.<h4>Design</h4>A multicentre randomised controlled equivalence trial. The study was not masked.<h4>Settings</h4>Gynaecological departments in two hospitals in a low-resource setting, Kenya.<h4>Population</h4>Women (n=1094) with incomplete abortion in the first trimester, seeking PAC between 1 June 2013 to 31 May 2016. Par ...[more]

PMID: 29018067

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Project description:BackgroundA large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to physicians who are few and unequally distributed, with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second-trimester post-abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians.MethodsA randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size > 12 weeks up to 18 weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or a physician (control arm). Enrolled participants will receive 400 μg misoprostol administered sublingually every 3 h up to five doses within 24 h at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 h will undergo surgical uterine evacuation. Pre discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications, with follow-up 14 days later to assess secondary outcomes. Analyses will be by intention to treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% confidence interval) and equivalence established if this lies between the predefined range of - 5% and + 5%. Chi-square tests will be used for comparison of outcome and t tests used to compare mean values. P ≤ 0.05 will be considered statistically significant.DiscussionOur study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access.Trial registrationClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.

Project description:BackgroundMidwives are a large proportion of Ethiopia's health care workforce, and their attitudes and practices shape the quality of reproductive health care, including safe abortion care (SAC) services. This study examines how midwives' conceptions of their professional roles and views on women who have abortions relate to their willingness to provide respectful SAC.MethodsThis study uses a cross-sectional, mixed methods design to conduct a regionally representative survey of midwives in Ethiopia's five largest regions (Oromia; Amhara; Southern Nations, Nationalities, and Peoples [SNNP]; Tigray; and Addis Ababa) with a multistage, cluster sampling design (n = 944). The study reports survey-weighted population estimates and the results of multivariate logistic regression analyzing factors associated with midwives' willingness to provide SAC. Survey data were triangulated with results from seven focus group discussions (FGDs) held with midwives in the five study regions. Deductive and inductive codes were used to thematically analyze these data.ResultsThe study surveyed 960 respondents. An estimated half of midwives believed that providing SAC was a professional duty. Slightly more than half were willing to provide SAC. A belief in right of refusal was common: two-thirds of respondents said that midwives should be able to refuse SAC provision on moral or religious grounds. Modifiable factors positively associated with willingness to provide SAC were SAC training (AOR 4.02; 95% CI 2.60, 6.20), agreeing that SAC refusal risked women's lives (AOR 1.69; 95% CI 1.20, 2.37), and viewing SAC provision as a professional duty (AOR 1.72; 95% CI 1.23, 2.39). In line with survey findings, a substantial number of FGD participants stated they had the right to refuse SAC. Responses to client scenarios revealed "directive counseling" to be common: many midwives indicated that they would actively attempt to persuade clients to act as they (the midwives) thought was best, rather than support clients in making their own decisions.ConclusionFindings suggest a need for new guidelines to clarify procedures surrounding conscientious objection and refusal to provide SAC, as well as initiatives to equip midwives to provide rights-based, patient-centered counseling and avoid directive counseling.

Dataset Information

Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians: a randomised controlled equivalence trial in a low-resource setting in Kenya.

Publications

Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians: a randomised controlled equivalence trial in a low-resource setting in Kenya.

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