Evidence map›Paper›PMID 19089777›Full record

Trial reportThe journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians2009

Side effects of oral misoprostol for the prevention of postpartum hemorrhage: results of a community-based randomised controlled trial in rural India.

Shobhana S Patted, Shivaprasad S Goudar, Vijaya A Naik, Mrutyunjaya B Bellad, Stanley A Edlavitch, Bhalchandra S Kodkany, Ashlesha Patel, Hrishikesh Chakraborty, Richard J Derman, Stacie E Geller

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 8 pooled it
2.8field-weighted citation impact, top 9% 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

14 citing papers in PubMed, 8 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Postpartum misoprostol for preventing maternal mortality and morbidity.The Cochrane database of systematic reviews · 2013
    Pooled it
  7. Prostaglandins for preventing postpartum haemorrhage.The Cochrane database of systematic reviews · 2012
    Pooled it
  8. Postpartum haemorrhage: prevention.BMJ clinical evidence · 2011
    Pooled it
  9. Trial
  10. Trial
  11. Article
  12. Review
  13. Review
  14. High fever following postpartum administration of sublingual misoprostol.BJOG : an international journal of obstetrics and gynaecology · 2010
    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

10 authors at 6 institutions in 2 countries.

Shobhana S PattedDepartment of Obstetrics and Gynecology, Jawaharal Nehru Medical College, Belgaum, India. shobhanapatted@yahoo.com
Shivaprasad S Goudar
Vijaya A Naik
Mrutyunjaya B Bellad
Stanley A Edlavitch
Bhalchandra S Kodkany
Ashlesha Patel
Hrishikesh Chakraborty
Richard J Derman
Stacie E Geller
Jawaharlal Nehru Medical College · INJefferson College · USJohn H. Stroger, Jr. Hospital of Cook County · USRTI International · USUniversity of Illinois Chicago · USUniversity of Missouri–Kansas City · US

Funding

Zika in Pregnancy Supplemental Funding requestU01HD040636 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MCCLURE, ELIZABETH M · 2001 to 2017
$37.5M
UMKC-JNMC Global Network for Women's and Children's Health Research UnitU01HD042372 · NICHD · UNIVERSITY OF MISSOURI KANSAS CITY · PI DERMAN, RICHARD J · 2001 to 2012
$6.9M
NICHD NIH HHS U01 HD042372NICHD NIH HHS U01 HD40636NICHD NIH HHS U01 HD42372
6 · The paper itself

Abstract

objectiveTo investigate the side effects of 600 microg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH).

methodsOne thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum. Newborns were evaluated within 24 h for diarrhea, vomiting and fever. Symptoms were graded as absent, mild-to-moderate or severe.

resultsWomen who received misoprostol had a significantly greater incidence of shivering (52%vs. 17%, p < 0.001) and fever (4.2%vs. 1.1%, p < 0.001) at 2 h postpartum compared with women who received placebo. At 24 h, women in the misoprostol group experienced significantly more shivering (4.6%vs. 1.4%, p < 0.001) and fever (1.4%vs. 0.4%, p < 0.03). There were no differences in nausea, vomiting or diarrhea between the two groups. There were no differences in the incidence of vomiting, diarrhea or fever for newborns.

conclusionsMisoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks.

Indexed as

Rural PopulationAdministration, OralDiarrhea, InfantileFemaleFeverHumansIncidenceIndiaInfant, NewbornMaternal-Fetal ExchangeMisoprostolNauseaOxytocicsPlacebosPostpartum HemorrhagePregnancyMisoprostolOxytocicsPlacebos

Identifiers

PMID19089777
PMCPMC13307447
OpenAlexW2167091097

What OpenQuestion holds

Textmetadata
LicenceTDM
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.