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.

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 Uga...

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Main Authors: Amanda Cleeve, Josaphat Byamugisha, Kristina Gemzell-Danielsson, Nazarius Mbona Tumwesigye, Susan Atuhairwe, Elisabeth Faxelid, Marie Klingberg-Allvin
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2016-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC4752492?pdf=render
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author Amanda Cleeve
Josaphat Byamugisha
Kristina Gemzell-Danielsson
Nazarius Mbona Tumwesigye
Susan Atuhairwe
Elisabeth Faxelid
Marie Klingberg-Allvin
author_facet Amanda Cleeve
Josaphat Byamugisha
Kristina Gemzell-Danielsson
Nazarius Mbona Tumwesigye
Susan Atuhairwe
Elisabeth Faxelid
Marie Klingberg-Allvin
author_sort Amanda Cleeve
collection DOAJ
description 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.
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spelling doaj.art-b63c4d3d87504b8989109a80fbf635af2022-12-22T03:43:12ZengPublic Library of Science (PLoS)PLoS ONE1932-62032016-01-01112e014917210.1371/journal.pone.0149172Women'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 CleeveJosaphat ByamugishaKristina Gemzell-DanielssonNazarius Mbona TumwesigyeSusan AtuhairweElisabeth FaxelidMarie Klingberg-AllvinOBJECTIVE: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.http://europepmc.org/articles/PMC4752492?pdf=render
spellingShingle Amanda Cleeve
Josaphat Byamugisha
Kristina Gemzell-Danielsson
Nazarius Mbona Tumwesigye
Susan Atuhairwe
Elisabeth Faxelid
Marie Klingberg-Allvin
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.
PLoS ONE
title 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.
title_full 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.
title_fullStr 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.
title_full_unstemmed 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.
title_short 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.
title_sort 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
url http://europepmc.org/articles/PMC4752492?pdf=render
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