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.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01844024.
authors.affiliation: Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.|WHO Center for Human Reproduction, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Amanda
authors.initials: A
authors.lastname: Cleeve
authors.affiliation: Department of Obstetrics and Gynaecology, Mulago Hospital, Kampala, Uganda.|Department of Obstetrics and Gynaecology, Makerere University College of Health Sciences, Kampala, Uganda.
authors.forename: Josaphat
authors.initials: J
authors.lastname: Byamugisha
authors.affiliation: Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.|WHO Center for Human Reproduction, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Kristina
authors.initials: K
authors.lastname: Gemzell-Danielsson
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Makerere University, Kampala, Uganda.
authors.forename: Nazarius
authors.initials: N
authors.lastname: Mbona Tumwesigye
authors.affiliation: Department of Obstetrics and Gynaecology, Mulago Hospital, Kampala, Uganda.|Department of Obstetrics and Gynaecology, Makerere University College of Health Sciences, Kampala, Uganda.
authors.forename: Susan
authors.initials: S
authors.lastname: Atuhairwe
authors.affiliation: Department of Public Health Sciences, Global Health (IHCAR), Karolinska Institutet, Stockholm, Sweden.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Faxelid
authors.affiliation: Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.|School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.
authors.forename: Marie
authors.initials: M
authors.lastname: Klingberg-Allvin
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000009:adverse effects / Q000627:therapeutic use*; D000027:Abortion, Incomplete / Q000188:drug therapy* / Q000453:epidemiology; D000328:Adult; D005260:Female; D006801:Humans; D008880:Midwifery; D016595:Misoprostol / Q000009:adverse effects / Q000627:therapeutic use*; D014454:Uganda / Q000453:epidemiology
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D016595:Misoprostol