Dataset Information

Women's Acceptability of Misoprostol Treatment for Incomplete Abortion by Midwives and Physicians - Secondary Outcome Analysis from a Randomized Controlled Equivalence Trial at District Level in Uganda.

ABSTRACT: OBJECTIVE:This study aimed to assess women´s acceptability of diagnosis and treatment of incomplete abortion with misoprostol by midwives, compared with physicians. METHODS:This was an analysis of secondary outcomes from a multi-centre randomized controlled equivalence trial at district level in Uganda. Women with first trimester incomplete abortion were randomly allocated to clinical assessment and treatment with misoprostol by a physician or a midwife. The randomisation (1:1) was done in blocks of 12 and stratified for health care facility. Acceptability was measured in expectations and satisfaction at a follow up visit 14-28 days following treatment. Analysis of women's overall acceptability was done using a generalized linear mixed-effects model with an equivalence range of -4% to 4%. The study was not masked. The trial is registered at ClinicalTrials.org, NCT 01844024. RESULTS:From April 2013 to June 2014, 1108 women were assessed for eligibility of which 1010 were randomized (506 to midwife and 504 to physician). 953 women were successfully followed up and included in the acceptability analysis. 95% (904) of the participants found the treatment satisfactory and overall acceptability was found to be equivalent between the two study groups. Treatment failure, not feeling calm and safe following treatment, experiencing severe abdominal pain or heavy bleeding following treatment, were significantly associated with non-satisfaction. No serious adverse events were recorded. CONCLUSIONS:Treatment of incomplete abortion with misoprostol by midwives and physician was highly, and equally, acceptable to women. TRIAL REGISTRATION:ClinicalTrials.gov NCT01844024.

SUBMITTER: Cleeve A

PROVIDER: S-EPMC4752492 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Women's Acceptability of Misoprostol Treatment for Incomplete Abortion by Midwives and Physicians - Secondary Outcome Analysis from a Randomized Controlled Equivalence Trial at District Level in Uganda.

Cleeve Amanda A Byamugisha Josaphat J Gemzell-Danielsson Kristina K Mbona Tumwesigye Nazarius N Atuhairwe Susan S Faxelid Elisabeth E Klingberg-Allvin Marie M

PloS one 20160212 2

<h4>Objective</h4>This study aimed to assess women´s acceptability of diagnosis and treatment of incomplete abortion with misoprostol by midwives, compared with physicians.<h4>Methods</h4>This was an analysis of secondary outcomes from a multi-centre randomized controlled equivalence trial at district level in Uganda. Women with first trimester incomplete abortion were randomly allocated to clinical assessment and treatment with misoprostol by a physician or a midwife. The randomisation (1:1) wa ...[more]

PMID: 26872219

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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: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.

Project description:In 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.A 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.Both 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.Misoprostol, 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.This study has been registered at clinicaltrials.gov as NCT00466999 and NCT01539408.

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.

Project description:BackgroundDepression is often underdiagnosed by treating health professionals. This is a situation in Malawi where there is no routine screening of depression at antenatal clinics. Recently, a Screening Protocol for Antenatal Depression (SPADe) that can be used by midwives to screen for antenatal depression was developed in Blantyre District. SPADe proposes multistage screening of antenatal depression by midwives which may enable early detection and treatment of pregnant women with depression. Proper treatment of antenatal depression can assist in achieving Sustainable Development Goals (SDGs). However, utilisation of SPADe in clinical practice to screening for depression in antenatal clinics has not been established yet. Therefore, the primary aim of this study is to assess feasibility of screening for depression by midwives using SPADe in antenatal clinics in Blantyre District. The secondary aim was to assess acceptability and fidelity of screening for depression by midwives using SPADe in antenatal clinics in Blantyre District.MethodsThis will be a feasibility study which will consist of scientific investigations that will support movement of evidence-based, effective health care approach, SPADe, from the clinical knowledge base into routine use. This study will consist three phases: phase 1 will introduce SPADe in antenatal clinics in Blantyre District where screening of depression is almost none existent; phase 2 will implement screening of depression using SPADe in antenatal clinics in Blantyre District; and phase 3 will evaluate the screening of antenatal depression using SPADe to establish its feasibility, acceptability and fidelity in antenatal clinics in Blantyre District.DiscussionThis study will establish and document feasibility, acceptability and fidelity of screening for depression by midwives using SPADe in antenatal clinics in Blantyre District. It is expected that midwives will develop more confidence in detecting and dealing with antenatal depression. Consequently, there will be increased numbers of pregnant women detected with depression by midwives and increased accessibility to mental health care by pregnant women in antenatal clinics.

Project description:Abortion is regulated in Mexico at the state level, and it is permitted under certain criteria in all 32 states, except in Mexico City where first-trimester abortion is decriminalized. Yet, more than a million abortions occur in Mexico each year. But most terminations occurring outside of Mexico City are clandestine and unsafe due to profound stigma against the procedure, lack of trained providers, lack of knowledge of where to find a safe abortion and poor knowledge of the laws. While this situation is moderated by the increasing use of misoprostol, a relatively safe method of abortion, the safety of the procedure cannot be assured in restrictive legal contexts. The purpose of this study is to explore women's experiences with induced abortion in three federal entities with different legal contexts, and whether abortion seeking behavior and experiences differ across these settings. The study was carried out in three states, representing three different degrees of restrictiveness of abortion legislation. Queretaro with the "most restrictive" law, Tabasco with a "moderately restrictive" law, and Mexico state with the "least restrictive" law. We hypothesize that women living in more restrictive states will resort to the use of more unsafe and risky methods and providers for their abortion than their counterparts in less restrictive states. Women who recently obtained abortions were selected through snowball sampling and qualitative data were collected from them using semi-structured indepth interviews. Data collection took place between mid-2014 and mid-2015, with a final sample size N = 60 (20 from each state). Various themes involved in the process of abortion seeking behavior were developed from the IDIs and examined here: women's knowledge of the abortion law in their state, reasons for having an abortion; the methods and providers used and women's positive and negative experiences with abortion methods and providers used. Our results indicate that abortion safety is not associated with the restrictiveness of abortion legislation. Findings show that there is a new pattern of abortion service provision in Mexico, with misoprostol, a relatively safe and easy to use method, playing an important role. Nevertheless, while access to misoprostol tends to increase the safety of abortion, the improvement is moderated by women and their informants (relatives, friends and partners) not having accurate information on how to safely self-induce an abortion with misoprostol. On the other hand, some women manage to have safe abortion in illegal setting by going to Mexico City or with the support of NGOs knowlegeable on abortion. Findings demonstrate the importance of decriminalization of abortion, but meanwhile, harm reduction strategies, including promotion of accurate information about self-use of misoprostol where abortion is legally restricted will result in safe abortion.

Dataset Information

Women's Acceptability of Misoprostol Treatment for Incomplete Abortion by Midwives and Physicians - Secondary Outcome Analysis from a Randomized Controlled Equivalence Trial at District Level in Uganda.

Publications

Women's Acceptability of Misoprostol Treatment for Incomplete Abortion by Midwives and Physicians - Secondary Outcome Analysis from a Randomized Controlled Equivalence Trial at District Level in Uganda.

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