Evidence map›Paper›PMID 36030801›Full record

Trial reportThe Lancet. Global health2022

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.

Susan Atuhairwe, Josaphat Byamugisha, Othman Kakaire, Claudia Hanson, Amanda Cleeve, Marie Klingberg-Allvin, Nazarius Mbona Tumwesigye, Kristina Gemzell-Danielsson

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in The Lancet. Global health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03622073 (Safety, Effectiveness and Acceptability of Misoprostol When Administered by Midwives Versus Physicians for Management of Incomplete Mid Trimester Abortion in Uganda), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03622073 nacompletednot on this map

Safety, Effectiveness and Acceptability of Misoprostol When Administered by Midwives Versus Physicians for Management of Incomplete Mid Trimester Abortion in Uganda: a Randomized Controlled Equivalence Trial.

TypeinterventionalSponsorMakerere UniversityRan2018 to 2021Enrolled1,191ConditionsIncomplete AbortionArmsMisoprostol treatment by Midwife, Misoprostol treatment by Doctor
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Susan AtuhairweDepartment of Obstetrics and Gynecology, Makerere University College of Health Sciences, Kampala, Uganda. Electronic address: atususan96@gmail.com.
Josaphat ByamugishaDepartment of Obstetrics and Gynecology, Makerere University College of Health Sciences, Kampala, Uganda.
Othman KakaireDepartment of Obstetrics and Gynecology, Makerere University College of Health Sciences, Kampala, Uganda.
Claudia HansonDepartment of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
Amanda CleeveDepartment of Women and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Marie Klingberg-AllvinDepartment of Women and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Nazarius Mbona TumwesigyeDepartment of Epidemiology and Biostatistics, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda.
Kristina Gemzell-DanielssonDepartment of Women and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Makerere University · UGKarolinska Institutet · SE

Funding

Wellcome TrustWellcome Trust 107742/Z/15/Z
6 · The paper itself

Abstract

backgroundTo 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.

methodsOur 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.

findingsBetween 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.

interpretationClinical 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.

fundingSwedish Research Council and THRiVE-2.

Indexed as

Abortifacient Agents, NonsteroidalAbortion, IncompleteAbortion, InducedMidwiferyMisoprostolPhysiciansFemaleHumansPregnancyPregnancy Trimester, FirstPregnancy Trimester, SecondUgandaAbortifacient Agents, NonsteroidalMisoprostol

Identifiers

PMID36030801
PMCPMC9605879
OpenAlexW4293123687

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.