Evidence map›Paper›PMID 32448257›Full record

Trial reportBMC pregnancy and childbirth2020

A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt.

Holly A Anger, Rasha Dabash, Nevine Hassanein, Emad Darwish, Mohamed Cherine Ramadan, Medhat Nawar, Dyanna Charles, Miral Breebaart, Beverly Winikoff

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pregnancy and childbirth, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02226588 (Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 28% 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.

NCT02226588 phase4completednot on this map

Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in El Beheira Governorate, Egypt

TypeinterventionalSponsorGynuity Health ProjectsRan2014 to 2016Enrolled2,827ConditionsPostpartum HemorrhageArmsMisoprostol
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
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

9 authors at 3 institutions in 2 countries.

Holly A AngerGynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA. hanger@gynuity.org.ORCID http://orcid.org/0000-0002-0042-4925
Rasha DabashGynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA.
Nevine HassaneinIndependent Reproductive Health Consultant, Cairo, Egypt.
Emad DarwishFaculty of Medicine, Alexandria University, 17 Champollion St, El Messalah, Alexandria, Egypt.
Mohamed Cherine RamadanDepartment of Obstetrics and Gynecology, El Galaa Teaching Hospital, Cairo, Egypt.
Medhat NawarEl Beheira Governorate, Ministry of Health and Population, Damanhour, Egypt.
Dyanna CharlesGynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA.
Miral BreebaartIndependent Public Health Consultant, Cairo, Egypt.
Beverly WinikoffGynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA.
Gynuity Health Projects · USAlexandria University · EGMinistry of Health and Population · EG

Funding

Bill and Melinda Gates Foundation (US) NA
6 · The paper itself

Abstract

backgroundPrevious community-based research shows that secondary prevention of postpartum hemorrhage (PPH) with misoprostol only given to women with above-average measured blood loss produces similar clinical outcomes compared to routine administration of misoprostol for prevention of PPH. Given the difficulty of routinely measuring blood loss for all deliveries, more operational models of secondary prevention are needed.

methodsThis cluster-randomized, non-inferiority trial included women giving birth with nurse-midwives at home or in Primary Health Units (PHUs) in rural Egypt. Two PPH management approaches were compared: 1) 600mcg oral misoprostol given to all women after delivery (i.e. primary prevention, current standard of care); 2) 800mcg sublingual misoprostol given only to women with 350-500 ml postpartum blood loss estimated using an underpad (i.e. secondary prevention). The primary outcome was mean change in pre- and post-delivery hemoglobin. Secondary outcomes included hemoglobin ≥2 g/dL and other PPH interventions.

resultsMisoprostol was administered after delivery to 100% (1555/1555) and 10.7% (117/1099) of women in primary and secondary prevention clusters, respectively. The mean drop in pre- to post-delivery hemoglobin was 0.37 (SD: 0.91) and 0.45 (SD: 0.76) among women in primary and secondary prevention clusters, respectively (difference adjusted for clustering = 0.01, one-sided 95% CI: < 0.27, p = 0.535). There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions.

conclusionsMisoprostol for secondary prevention of PPH is comparable to universal prophylaxis and can be implemented using local materials, such as underpads.

trial registrationClinicaltrials.gov NCT02226588, date of registration 27 August 2014.

Indexed as

Secondary PreventionAdultEgyptFemaleHemoglobinsHumansMisoprostolOxytocicsParturitionPostpartum HemorrhagePregnancyPrimary PreventionYoung AdultHemoglobinsMisoprostolOxytocicsHome-birthsLow and middle income countriesMidwivesMisoprostolPostpartum hemorrhageProphylaxisSecondary preventionTask-sharing

Identifiers

PMID32448257
PMCPMC7245883
OpenAlexW3026754898

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.