Evidence map›Paper›PMID 19852814›Full record

Trial reportBMC pregnancy and childbirth2009

Treatment of retained placenta with misoprostol: a randomised controlled trial in a low-resource setting (Tanzania).

Heleen J van Beekhuizen, Andrea B Pembe, Heiner Fauteck, Fred K Lotgering

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.4field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Prostaglandins for management of retained placenta.The Cochrane database of systematic reviews · 2014
    Pooled it
  2. Postpartum misoprostol for preventing maternal mortality and morbidity.The Cochrane database of systematic reviews · 2013
    Pooled it
  3. 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

4 authors at 4 institutions in 3 countries.

Heleen J van BeekhuizenDepartment of Obstetrics and Gynaecology, Erasmus Medical Centre, PO box 2040, 3000 CA Rotterdam, The Netherlands. Heleen@airpost.net
Andrea B Pembe
Heiner Fauteck
Fred K Lotgering
Erasmus MC · NLMuhimbili University of Health and Allied Sciences · TZRadboud University Nijmegen · NLUniversity of Lübeck · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRetained placenta is one of the common causes of maternal mortality in developing countries where access to appropriate obstetrical care is limited. Current treatment of retained placenta is manual removal of the placenta under anaesthesia, which can only take place in larger health care facilities. Medical treatment of retained placenta with prostaglandins E1 (misoprostol) could be cost-effective and easy-to-use and could be a life-saving option in many low-resource settings. The aim of this study is to assess the efficacy and safety of sublingually administered misoprostol in women with retained placenta in a low resource setting.

methods

designMulticentered randomised, double-blind, placebo-controlled trial, to be conducted in 5 hospitals in Tanzania, Africa. INCLUSION CRITERIA: Women with retained placenta, at a gestational age of 28 weeks or more and blood loss less than 750 ml, 30 minutes after delivery of the newborn despite active management of third stage of labour. Trial Entry & Randomisation & Study Medication: After obtaining informed consent, eligible women will be allocated randomly to the treatment groups using numbered envelopes that will be randomized in variable blocks containing identical capsules with either 800 microgram of misoprostol or placebo. The drugs will be given sublingually. The women, maternal care providers and researchers will be blinded to treatment allocation. SAMPLE SIZE: 117 women, to show a 40% reduction in manual removals of the placenta (p = 0.05, 80% power). The randomization will be misoprostol: placebo = 2:1. PRIMARY STUDY OUTCOME: Expulsion of the placenta without manual removal. Secondary outcome is the number of blood transfusions. DISCUSSION: This is a protocol for a randomized trial in a low resource setting to assess if medical treatment of women with retained placenta with misoprostol reduces the incidence of manual removal of the placenta. CLINICAL

trial registrationCurrent Controlled Trials ISRCTN16104753.

Indexed as

Developing CountriesAdministration, SublingualClinical ProtocolsDrug Administration ScheduleFemaleHumansMisoprostolOxytocicsPlacenta, RetainedPregnancyResearch DesignTanzaniaMisoprostolOxytocics

Identifiers

PMID19852814
PMCPMC2770987
OpenAlexW2096710128

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.