Marie Klingberg-Allvin1, Amanda Cleeve2, Susan Atuhairwe3, Nazarius Mbona Tumwesigye4, Elisabeth Faxelid5, Josaphat Byamugisha3, Kristina Gemzell-Danielsson6. 1. School of Education, Health and Social Studies, Dalarna University, Falun, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden. Electronic address: mkl@du.se. 2. Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden. 3. Department of Obstetrics and Gynaecology, Mulago Hospital, Kampala, Uganda; Makerere University College of Health Sciences, Kampala, Uganda. 4. Department of Epidemiology and Biostatistics, School of Public Health, Kampala, Uganda. 5. Global Health (IHCAR), Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden. 6. Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden; Karolinska University Hospital, Stockholm, Sweden.
Abstract
BACKGROUND:Misoprostol is established for the treatment of incomplete abortion but has not been systematically assessed when provided by midwives at district level in a low-resource setting. We investigated the effectiveness and safety of midwives diagnosing and treating incomplete abortion with misoprostol, compared with physicians. METHODS: We did a multicentre randomised controlled equivalence trial at district level at six facilities in Uganda. Eligibility criteria were women with signs of incomplete abortion. We randomly allocated women with first-trimester incomplete abortion to clinical assessment and treatment with misoprostol either by a physician or a midwife. The randomisation (1:1) was done in blocks of 12 and was stratified for study site. Primary outcome was complete abortion not needing surgical intervention within 14-28 days after initial treatment. The study was not masked. Analysis of the primary outcome was done on the per-protocol population with a generalised linear-mixed effects model. The predefined equivalence range was -4% to 4%. The trial was registered at ClinicalTrials.gov, number NCT01844024. FINDINGS:From April 30, 2013, to July 21, 2014, 1108 women were assessed for eligibility. 1010 women were randomly assigned to each group (506 to midwife group and 504 to physician group). 955 women (472 in the midwife group and 483 in the physician group) were included in the per-protocol analysis. 452 (95·8%) of women in the midwife group had complete abortion and 467 (96·7%) in the physician group. The model-based risk difference for midwife versus physician group was -0·8% (95% CI -2·9 to 1·4), falling within the predefined equivalence range (-4% to 4%). The overall proportion of women with incomplete abortion was 3·8% (36/955), similarly distributed between the two groups (4·2% [20/472] in the midwife group, 3·3% [16/483] in the physician group). No serious adverse events were recorded. INTERPRETATION: Diagnosis and treatment of incomplete abortion with misoprostol by midwives is equally safe and effective as when provided by physicians, in a low-resource setting. Scaling up midwives' involvement in treatment of incomplete abortion with misoprostol at district level would increase access to safe post-abortion care. FUNDING: The Swedish Research Council, Karolinska Institutet, and Dalarna University.
RCT Entities:
BACKGROUND:Misoprostol is established for the treatment of incomplete abortion but has not been systematically assessed when provided by midwives at district level in a low-resource setting. We investigated the effectiveness and safety of midwives diagnosing and treating incomplete abortion with misoprostol, compared with physicians. METHODS: We did a multicentre randomised controlled equivalence trial at district level at six facilities in Uganda. Eligibility criteria were women with signs of incomplete abortion. We randomly allocated women with first-trimester incomplete abortion to clinical assessment and treatment with misoprostol either by a physician or a midwife. The randomisation (1:1) was done in blocks of 12 and was stratified for study site. Primary outcome was complete abortion not needing surgical intervention within 14-28 days after initial treatment. The study was not masked. Analysis of the primary outcome was done on the per-protocol population with a generalised linear-mixed effects model. The predefined equivalence range was -4% to 4%. The trial was registered at ClinicalTrials.gov, number NCT01844024. FINDINGS: From April 30, 2013, to July 21, 2014, 1108 women were assessed for eligibility. 1010 women were randomly assigned to each group (506 to midwife group and 504 to physician group). 955 women (472 in the midwife group and 483 in the physician group) were included in the per-protocol analysis. 452 (95·8%) of women in the midwife group had complete abortion and 467 (96·7%) in the physician group. The model-based risk difference for midwife versus physician group was -0·8% (95% CI -2·9 to 1·4), falling within the predefined equivalence range (-4% to 4%). The overall proportion of women with incomplete abortion was 3·8% (36/955), similarly distributed between the two groups (4·2% [20/472] in the midwife group, 3·3% [16/483] in the physician group). No serious adverse events were recorded. INTERPRETATION: Diagnosis and treatment of incomplete abortion with misoprostol by midwives is equally safe and effective as when provided by physicians, in a low-resource setting. Scaling up midwives' involvement in treatment of incomplete abortion with misoprostol at district level would increase access to safe post-abortion care. FUNDING: The Swedish Research Council, Karolinska Institutet, and Dalarna University.
Authors: M Klingberg-Allvin; S Atuhairwe; A Cleeve; J K Byamugisha; E C Larsson; M Makenzius; M Oguttu; K Gemzell-Danielsson Journal: Glob Health Action Date: 2018 Impact factor: 2.640
Authors: Jenny A Cresswell; Onikepe O Owolabi; Nachela Chelwa; Mardieh L Dennis; Sabine Gabrysch; Bellington Vwalika; Mike Mbizvo; Veronique Filippi; Oona M R Campbell Journal: BMJ Glob Health Date: 2018-09-03
Authors: Jay Ghosh; Argyro Papadopoulou; Adam J Devall; Hannah C Jeffery; Leanne E Beeson; Vivian Do; Malcolm J Price; Aurelio Tobias; Özge Tunçalp; Antonella Lavelanet; Ahmet Metin Gülmezoglu; Arri Coomarasamy; Ioannis D Gallos Journal: Cochrane Database Syst Rev Date: 2021-06-01
Authors: Marlene Makenzius; Monica Oguttu; Marie Klingberg-Allvin; Kristina Gemzell-Danielsson; Theresa M A Odero; Elisabeth Faxelid Journal: BMJ Open Date: 2017-10-10 Impact factor: 2.692