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Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial.

ABSTRACT: BACKGROUND:A 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 Unsafe and outdated methods like sharp curettage are frequently used.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. METHODS:A 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 ?g 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. DISCUSSION:Our 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 REGISTRATION:ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.

SUBMITTER: Atuhairwe S

PROVIDER: S-EPMC6588936 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial.

Atuhairwe Susan S Byamugisha Josaphat J Klingberg-Allvin Marie M Cleeve Amanda A Hanson Claudia C Tumwesigye Nazarius Mbona NM Kakaire Othman O Danielsson Kristina Gemzell KG

Trials 20190621 1

<h4>Background</h4>A 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 ...[more]

PMID: 31227019

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Project description:ObjectiveTo assess the effectiveness of midwives administering misoprostol to women with incomplete abortion seeking post-abortion care (PAC), compared with physicians.DesignA multicentre randomised controlled equivalence trial. The study was not masked.SettingsGynaecological departments in two hospitals in a low-resource setting, Kenya.PopulationWomen (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.Interventions600 µg misoprostol orally, and contraceptive counselling by a physician or midwife.Main outcome measuresComplete 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.ResultsThe 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.ConclusionsTreatment 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 numberNCT01865136; Results.

Project description:BackgroundThe availability of modern contraception including long-acting reversible contraceptives (LARC), is a fundamental component of postabortion care. Findings from a recent randomized controlled trial (RCT) in South Africa comparing immediate to delayed insertion of the copper intrauterine device (IUD) after medical abortion (MA) at 17-20 gestational weeks showed that immediate insertion resulted in higher IUD use at 6 weeks postabortion, but that expulsion rates were significantly higher than for delayed insertion. This study aims to explore barriers, facilitators, and context-specific factors relevant to the implementation of immediate IUD provision after second trimester medical abortion.MethodsWe performed a qualitative study alongside the RCT in which we conducted in-depth interviews with 14 staff providing healthcare to study participants and 24 study participants. Research questions explored barriers and facilitators to implementation of immediate IUD insertion, contraceptive decision-making, and the impact of context and supplementary trial activities on service provision. Interviews were recorded and transcribed, with translation into English if needed. We performed a triangulated thematic analysis at the level of the transcribed interview text.ResultsContraceptive counselling at the abortion facility by a study nurse improved knowledge, corrected misconceptions, and increased demand for the IUD postabortion. Women expressed a clear preference for immediate insertion. Convenience, protection from pregnancy and privacy issues were paramount and women expressed preference for engagement with staff who knew their abortion history, and with whom they had an established connection. Doctors and nurses were generally in favour of immediate insertion and said it could be incorporated into standard care if women wanted this. This contrasted with the need for interventions by the research team to reinforce adherence by staff to provide contraception as allocated during the trial.ConclusionsWomen and staff favour immediate IUD insertion after second trimester medical abortion, but service delivery may require structures that ensure timely insertion postabortion, continuity of care, communication that mitigates loss to follow-up and training of staff to ensure competence.

Project description:BackgroundIn low-resource settings, where abortion is highly restricted and self-induced abortions are common, access to post-abortion care (PAC) services, especially treatment of incomplete terminations, is a priority. Standard post-abortion care has involved surgical intervention but can be hard to access in these areas. Misoprostol provides an alternative to surgical intervention that could increase access to abortion care. We sought to gather additional evidence regarding the efficacy of 400 mcg of sublingual misoprostol vs. standard surgical care for treatment of incomplete abortion in the environments where need for economical non-surgical treatments may be most useful.MethodsA total of 860 women received either sublingual misoprostol or standard surgical care for treatment of incomplete abortion in a multi-site randomized trial. Women with confirmed incomplete abortion, defined as past or present history of vaginal bleeding during pregnancy and an open cervical os, were eligible to participate. Participants returned for follow-up one week later to confirm clinical status. If abortion was incomplete at that time, women were offered an additional follow-up visit or immediate surgical evacuation.ResultsBoth misoprostol and surgical evacuation are highly effective treatments for incomplete abortion (misoprostol: 94.4%, surgical: 100.0%). Misoprostol treatment resulted in a somewhat lower chance of success than standard surgical practice (RR = 0.90; 95% CI: 0.89-0.92). Both tolerability of side effects and women's satisfaction were similar in the two study arms.ConclusionMisoprostol, much easier to provide than surgery in low-resource environments, can be used safely, successfully, and satisfactorily for treatment of incomplete abortion. Focus should shift to program implementation, including task-shifting the provision of post-abortion care to mid- and low- level providers, training and assurance of drug availability.Trial registrationThis study has been registered at clinicaltrials.gov as NCT00466999 and NCT01539408.

Project description:ObjectiveTo assess whether indicators of limited access to services explained changes in rates of second-trimester abortion after implementation of a restrictive abortion law in Texas.MethodsWe used cross-sectional vital statistics data on abortions performed in Texas before (November 1, 2011-October 31, 2012) and after (November 1, 2013-October 31, 2014) implementation of Texas' abortion law. We conducted monthly mystery client calls for information about abortion facility closures and appointment wait times to calculate distance from women's county of residence to the nearest open Texas facility, the number of open abortion facilities in women's region of residence (facility network size), and days until the next consultation visit. We estimated mixed-effects logistic regression models to assess the association between obtaining abortion care after the law's implementation and having a second-trimester abortion (12 weeks of gestation or more), after adjustment for distance, network size, and wait times.ResultsOverall, 64,902 Texas-resident abortions occurred in the period before the law was introduced and 53,174 occurred after its implementation. After implementation, 14.5% of abortions were performed at 12 weeks of gestation or more, compared with 10.5% before the law (P<.001; unadjusted odds ratio [OR] 1.45; 95% CI 1.40-1.50). Adjusting for distance to the nearest facility and facility network size reduced the odds of having a second-trimester abortion after implementation (OR 1.17; 95% CI 1.10-1.25). Women living 50-99 miles from the nearest facility (vs less than 10 miles) had higher odds of second-trimester abortion (OR 1.24; 95% CI 1.11-1.39), as did women in regions with less than one facility per 250,000 reproductive-aged women compared with women in areas that had 1.5 or more facilities (OR 1.57; 95% CI 1.41-1.75). After implementation, women waited 1 to 14 days for a consultation visit; longer waits were associated with higher odds of second-trimester abortion.ConclusionIncreases in second-trimester abortion after the law's implementation were due to women having more limited access to abortion services.

Project description:Complications following spontaneous or induced abortion are a major cause of maternal morbidity. To manage these complications, post-abortion care (PAC) services should be readily available and easy to access. Standard PAC treatment includes surgical interventions that are highly effective but require surgical providers and medical centers that have the necessary space and equipment. Misoprostol has been shown to be an effective alternative to surgical evacuation and can be offered by lower level clinicians. This study sought to assess whether 400 mcg sublingual misoprostol could effectively evacuate the uterus after incomplete abortion and to confirm its applicability for use at lower level settings.All women presenting with incomplete abortion at one of three hospitals in Vietnam were enrolled. Providers were not asked to record if the abortion was spontaneous or induced. It is likely that all were spontaneous given the legal status and easy access to abortion services in Vietnam. Participants were given 400 mcg sublingual misoprostol and instructed to hold the pills under their tongue for 30 minutes and then swallow any remaining fragments. They were then asked to return one week later to confirm their clinical status. Study clinicians were instructed to confirm a complete expulsion clinically. All women were asked to complete a questionnaire regarding satisfaction with the treatment.Three hundred and two women were enrolled between September 2009 and May 2010. Almost all participants (96.3%) had successful completions using a single dose of 400 mcg misoprostol. The majority of women (87.2%) found the side effects to be tolerable or easily tolerable. Most women (84.3%) were satisfied or very satisfied with the treatment they received; only one was dissatisfied (0.3%). Nine out of ten women would select this method again and recommend it to a friend (91.0% and 90.0%, respectively).This study confirms that 400 mcg sublingual misoprostol effectively evacuates the uterus for most women experiencing incomplete abortion. The high levels of satisfaction and side effect tolerability also attest to the ease of use of this method. From these data and given the international consensus around the effectiveness of misoprostol for incomplete abortion care, it seems timely that use of the drug for this indication be widely expanded both throughout Vietnam and wherever access to abortion care is limited.ClinicalTrials.gov, NCT00670761.

Dataset Information

Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial.

Publications

Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial.

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