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.

Amanda Cleeve,Kristina Gemzell-Danielsson,Elisabeth Faxelid,Marie Klingberg-Allvin,Susan Atuhairwe,Josaphat Byamugisha,Nazarius Mbona Tumwesigye,Sharon Cameron

doi:10.1371/journal.pone.0149172

Abstract

ObjectiveThis study aimed to assess women´s acceptability of diagnosis and treatment of incomplete abortion with misoprostol by midwives, compared with physicians.MethodsThis 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.ResultsFrom 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.ConclusionsTreatment of incomplete abortion with misoprostol by midwives and physician was highly, and equally, acceptable to women.Trial RegistrationClinicalTrials.gov NCT01844024

Highlights

Complications from unsafe abortions continue to be a major contributor to the global maternal mortality ratio [1]
Womens Acceptability - Task Shifting In Post Abortion Care
In order to address the burden of unsafe abortion, universal access to post abortion care (PAC), consisting of emergency treatment of complications from spontaneous or induced abortions and contraceptive services, is crucial [4]

Summary

Methods

The study was approved by the Scientific and ethical review group at the Reproductive Health and Research Department, WHO, Geneva. Non-satisfactory meant that treatment was experienced as “worse than expected” or the women would not recommend the treatment to a friend Measures such as bleeding and pain following treatment, feeling calm and safe following treatment, unscheduled visits, treatment outcome (complete/incomplete abortion), adverse events, and side effects, were regarded as independent variables reflecting women’s treatment experience. The randomization list and sequentially numbered, opaque and sealed envelopes, each containing a random allocation, were prepared at the coordinating centre in Mulago Hospital, and later opened by the research assistants after obtaining consent Both verbal and written informed consent for participation was sought and obtained from all women included in the study. There were no major differences in socio-demographic background or reproductive history between groups except that significantly more women in the midwife group reported to have induced the current abortion (14.6% vs 9.7%, p-value

Results

Introduction

Discussion

Strengths and limitations

Conclusion