Comparison of the effectiveness and safety of treatment of incomplete second trimester abortion with misoprostol provided by midwives and physicians: a randomised, controlled, equivalence trial in Uganda.
Journal
The Lancet. Global health
ISSN: 2214-109X
Titre abrégé: Lancet Glob Health
Pays: England
ID NLM: 101613665
Informations de publication
Date de publication:
10 2022
10 2022
Historique:
received:
18
02
2022
revised:
23
06
2022
accepted:
28
06
2022
pubmed:
29
8
2022
medline:
21
9
2022
entrez:
28
8
2022
Statut:
ppublish
Résumé
To address the knowledge gaps in the provision of post-abortion care by midwives for women in the second trimester, we investigated the effectiveness and safety of treatment for incomplete second trimester abortion with misoprostol, comparing care provision by midwives with that provided by physicians in Uganda. Our multicentre, randomised, controlled, equivalence trial undertaken in 14 health facilities in Uganda recruited women with incomplete abortion of uterine size 13-18 weeks. We randomly assigned (1:1) women to clinical assessment and treatment by either midwife or physician. The randomisation sequence was computer generated, in blocks of four to 12, and stratified for study site. Participants received sublingual misoprostol (400 μg once every 3 h for up to five doses). The study was not concealed from the health-care providers and study participants. Primary outcome was complete abortion within 24 h that did not require surgical evacuation. Analysis was per-protocol and intention to treat; the intention-to-treat population consisted of women who were randomised, received at least one dose of misoprostol, and reported primary outcome data, and the per-protocol population excluded women with unexplained discontinuation of treatment. We used generalised mixed-effects models to obtain the risk difference. The predefined equivalence range was -5% to 5%. The trial was registered at ClinicalTrials.gov, NCT03622073. Between Aug 14, 2018, and Nov 16, 2021, 1191 eligible women were randomly assigned to each group (593 women to the midwife group and 598 to the physician group). 1164 women were included in the per-protocol analysis, and 530 (92%) of 577 women in the midwife group and 553 (94%) of 587 women in the physician group had a complete abortion within 24 h. The model-based risk difference for the midwife versus physician group was -2·3% (95% CI -4·4 to -0·3), and within our predefined equivalence range (-5% to 5%). Two women in the midwife group received blood transfusion. Clinical assessment and treatment of second trimester incomplete abortion with misoprostol provided by midwives was equally effective and safe as when provided by physicians. In low-income settings, inclusion of midwives in the medical management of uncomplicated second trimester incomplete abortion has potential to increase women's access to safe post-abortion care. Swedish Research Council and THRiVE-2.
Sections du résumé
BACKGROUND
To address the knowledge gaps in the provision of post-abortion care by midwives for women in the second trimester, we investigated the effectiveness and safety of treatment for incomplete second trimester abortion with misoprostol, comparing care provision by midwives with that provided by physicians in Uganda.
METHODS
Our multicentre, randomised, controlled, equivalence trial undertaken in 14 health facilities in Uganda recruited women with incomplete abortion of uterine size 13-18 weeks. We randomly assigned (1:1) women to clinical assessment and treatment by either midwife or physician. The randomisation sequence was computer generated, in blocks of four to 12, and stratified for study site. Participants received sublingual misoprostol (400 μg once every 3 h for up to five doses). The study was not concealed from the health-care providers and study participants. Primary outcome was complete abortion within 24 h that did not require surgical evacuation. Analysis was per-protocol and intention to treat; the intention-to-treat population consisted of women who were randomised, received at least one dose of misoprostol, and reported primary outcome data, and the per-protocol population excluded women with unexplained discontinuation of treatment. We used generalised mixed-effects models to obtain the risk difference. The predefined equivalence range was -5% to 5%. The trial was registered at ClinicalTrials.gov, NCT03622073.
FINDINGS
Between Aug 14, 2018, and Nov 16, 2021, 1191 eligible women were randomly assigned to each group (593 women to the midwife group and 598 to the physician group). 1164 women were included in the per-protocol analysis, and 530 (92%) of 577 women in the midwife group and 553 (94%) of 587 women in the physician group had a complete abortion within 24 h. The model-based risk difference for the midwife versus physician group was -2·3% (95% CI -4·4 to -0·3), and within our predefined equivalence range (-5% to 5%). Two women in the midwife group received blood transfusion.
INTERPRETATION
Clinical assessment and treatment of second trimester incomplete abortion with misoprostol provided by midwives was equally effective and safe as when provided by physicians. In low-income settings, inclusion of midwives in the medical management of uncomplicated second trimester incomplete abortion has potential to increase women's access to safe post-abortion care.
FUNDING
Swedish Research Council and THRiVE-2.
Identifiants
pubmed: 36030801
pii: S2214-109X(22)00312-6
doi: 10.1016/S2214-109X(22)00312-6
pmc: PMC9605879
pii:
doi:
Substances chimiques
Abortifacient Agents, Nonsteroidal
0
Misoprostol
0E43V0BB57
Banques de données
ClinicalTrials.gov
['NCT03622073']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1505-e1513Subventions
Organisme : Wellcome Trust
ID : 107742/Z/15/Z
Pays : United Kingdom
Informations de copyright
Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests We declare no competing interests.
Références
Trials. 2019 Jun 21;20(1):376
pubmed: 31227019
Lancet Glob Health. 2014 Jun;2(6):e323-33
pubmed: 25103301
Hum Resour Health. 2018 May 2;16(1):20
pubmed: 29716613
BMJ Glob Health. 2021 Feb;6(2):
pubmed: 33547174
Int Fam Plan Perspect. 2003 Sep;29(3):106-11
pubmed: 14519586
Cochrane Database Syst Rev. 2017 Jan 31;1:CD007223
pubmed: 28138973
BMJ Open. 2017 Oct 10;7(10):e016157
pubmed: 29018067
Ultrasound Obstet Gynecol. 2009 Jul;34(1):104-9
pubmed: 19517421
BMJ Open. 2018 Feb 10;8(2):e019658
pubmed: 29440163
BMC Womens Health. 2014 Sep 09;14:108
pubmed: 25199407
Lancet. 2015 Jun 13;385(9985):2392-8
pubmed: 25817472
Glob Health Action. 2013 Apr 24;6:1-11
pubmed: 23618341
Best Pract Res Clin Obstet Gynaecol. 2020 Jan;62:101-112
pubmed: 31331743
Lancet. 2017 Nov 25;390(10110):2372-2381
pubmed: 28964589
BMC Health Serv Res. 2014 Jan 21;14:28
pubmed: 24447321
PLoS One. 2016 Nov 1;11(11):e0165812
pubmed: 27802338
JAMA. 2012 Dec 26;308(24):2594-604
pubmed: 23268518
J Obstet Gynaecol. 2018 Oct;38(7):961-966
pubmed: 29577786