Evidence map›Paper›PMID 29018067›Full record

Trial reportBMJ open2017

Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians: a randomised controlled equivalence trial in a low-resource setting in Kenya.

Marlene Makenzius, Monica Oguttu, Marie Klingberg-Allvin, Kristina Gemzell-Danielsson, Theresa M A Odero, Elisabeth Faxelid

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

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01865136 (Post-abortion Care and Contraceptive Counselling by Midwives or Physicians - a Randomized Controlled Trial in Kisumu, Western Kenya), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
3.7field-weighted citation impact, top 7% 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.

NCT01865136 phase4completednot on this map

Post-abortion Care and Contraceptive Counselling by Midwives or Physicians - a Randomized Controlled Trial in Kisumu, Western Kenya

TypeinterventionalSponsorKarolinska InstitutetRan2013 to 2016Enrolled890ConditionsPregnancyArmsMedical Post Abortion Care
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Methods for managing miscarriage: a network meta-analysis.The Cochrane database of systematic reviews · 2021
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  13. Maternal Mortality from Induced Abortion in Malawi: What Does the Latest Evidence Suggest?International journal of environmental research and public health · 2021
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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

6 authors at 5 institutions in 2 countries.

Marlene MakenziusDepartment of Public Health Sciences Global Health (IHCAR), Karolinska Institutet, Stockholm, Sweden.ORCID http://orcid.org/0000-0001-6014-6296
Monica OguttuKisumu Medical and Education Trust (KMET), Reproductive Health, Kisumu, Kenya.
Marie Klingberg-AllvinSchool of Education, Health and Social Studies, Dalarna University, Falun, Sweden.
Kristina Gemzell-DanielssonDivision of Obstetrics and Gynaecology, Karolinska University Hospital, Stockholm, Sweden.
Theresa M A OderoCollege of Health Sciences, School of Nursing Sciences, University of Nairobi, Nairobi, Kenya.
Elisabeth FaxelidDepartment of Public Health Sciences Global Health (IHCAR), Karolinska Institutet, Stockholm, Sweden.
Dalarna University · SEKarolinska Institutet · SEKarolinska University Hospital · SEUniversity of Nairobi · KEUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the effectiveness of midwives administering misoprostol to women with incomplete abortion seeking post-abortion care (PAC), compared with physicians.

designA multicentre randomised controlled equivalence trial. The study was not masked. SETTINGS: Gynaecological departments in two hospitals in a low-resource setting, Kenya. POPULATION: Women (n=1094) with incomplete abortion in the first trimester, seeking PAC between 1 June 2013 to 31 May 2016. Participants were randomly assigned to receive treatment from midwives or physicians. 409 and 401 women in the midwife and physician groups, respectively, were included in the per-protocol analysis.

interventions600 µg misoprostol orally, and contraceptive counselling by a physician or midwife.

main outcome measuresComplete abortion not needing surgical intervention within 7-10 days. The main outcome was analysed on the per-protocol population with a generalised estimating equation model. The predefined equivalence range was -4% to 4%. Secondary outcomes were analysed descriptively.

resultsThe proportion of complete abortion was 94.8% (768/810): 390 (95.4%) in the midwife group and 378 (94.3%) in the physician group. The proportion of incomplete abortion was 5.2% (42/810), similarly distributed between midwives and physicians. The model-based risk difference for midwives versus physicians was 1.0% (-4.1 to 2.2). Most women felt safe (97%; 779/799), and 93% (748/801) perceived the treatment as expected/easier than expected. After contraceptive counselling the uptake of a contraceptive method after 7-10 days occurred in 76% (613/810). No serious adverse events were recorded.

conclusionsTreatment of incomplete abortion with misoprostol provided by midwives is equally effective, safe and accepted by women as when administered by physicians in a low-resource setting. Systematically provided contraceptive counselling in PAC is effective to mitigate unmet need for contraception. TRIAL REGISTRATION NUMBER: NCT01865136; Results.

Indexed as

Abortion, InducedNurse MidwivesPhysiciansAbortifacient Agents, NonsteroidalAbortion, IncompleteAdultFemaleHealth ResourcesHumansKenyaMaleMiddle AgedMidwiferyMisoprostolOutcome Assessment, Health CarePatient SafetyAbortifacient Agents, NonsteroidalMisoprostolCommunity GynaecologyHealth PolicyMaternal MedicineReproductive Medicine

Identifiers

PMID29018067
PMCPMC5652492
OpenAlexW2763272450

What OpenQuestion holds

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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.