Evidence map›Paper›PMID 20502294›Full record

Trial reportObstetrics and gynecology2010

Chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: a randomized controlled trial.

Sarah Saleem, Dwight J Rouse, Elizabeth M McClure, Anita Zaidi, Tahira Reza, Y Yahya, I A Memon, N H Khan, G Memon, N Soomro and 4 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03438110 (Project to Understand & Research Preterm Pregnancy Outcomes-South Asia), which is not on this map. Cited by 13 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 6 pooled it
5.8field-weighted citation impact, top 4% 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.

NCT03438110 completednot on this mapstarted 2018, after this paper: background citation

Project to Understand & Research Preterm Pregnancy Outcomes-South Asia (PURPOSe)

TypeobservationalSponsorRTI InternationalRan2018 to 2020Enrolled1,226ConditionsNeonatal Death, Stillbirth
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 6 syntheses or guidelines pooled it, 40 citations in OpenAlex.

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  5. Umbilical cord antiseptics for preventing sepsis and death among newborns.The Cochrane database of systematic reviews · 2013
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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

14 authors at 1 institution in 1 country.

Sarah SaleemFrom Aga Khan University, Karachi, Pakistan; University of Alabama at Birmingham, Birmingham, Alabama; RTI International, Research Triangle Park, North Carolina; Dow University of Health Sciences, Karachi, Pakistan, Eunice Kennedy Shriver National Institute of Child and Human Development, Bethesda, Maryland; and Drexel University College of Medicine, Philadelphia, Philadelphia.
Dwight J Rouse
Elizabeth M McClure
Anita Zaidi
Tahira Reza
Y Yahya
I A Memon
N H Khan
G Memon
N Soomro
Omrana Pasha
Linda L Wright
Janet Moore
Robert L Goldenberg
Philadelphia University · US

Funding

Zika in Pregnancy Supplemental Funding requestU01HD040636 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MCCLURE, ELIZABETH M · 2001 to 2017
$37.5M
Global Network for Women's and Children's Health Research Data Coordinating CenterU24HD092094 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI Elizabeth M McClure · 2017 to 2026
$17.8M
UAB/AKU Global Network Research UnitU01HD040607 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GOLDENBERG, ROBERT L · 2001 to 2012
$8.5M
NICHD NIH HHS U01 HD040607NICHD NIH HHS U01 HD040636NICHD NIH HHS U24 HD092094
6 · The paper itself

Abstract

objectiveTo estimate the effects of chlorhexidine vaginal and baby wipes on fetal and neonatal mortality, respectively, and infection-related morbidity.

methodsWe performed a placebo-controlled, randomized trial of chlorhexidine vaginal and neonatal wipes to reduce neonatal sepsis and mortality in three hospitals in Pakistan. The primary study outcome was a composite of neonatal sepsis or 7-day perinatal mortality.

resultsFrom 2005 to 2008, 5,008 laboring women and their neonates were randomly assigned to receive either chlorhexidine wipes (n=2,505) or wipes with a saline placebo (n=2,503). The primary outcome was similar in the chlorhexidine and control groups (3.1% compared with 3.4%; relative risk 0.91, 95% confidence interval 0.67-1.24) as was the composite rate of neonatal sepsis or 28-day perinatal mortality (3.8% compared with 3.9%, relative risk 0.96, 95% confidence interval 0.73-1.27). At day 7, the chlorhexidine group had a lower rate of neonatal skin infection (3.3% compared with 8.2%, P<.001). With the exception of less frequent 7-day hospitalization in the chlorhexidine group, there were no significant differences in maternal outcomes between the groups.

conclusionUsing maternal chlorhexidine vaginal wipes during labor and neonatal chlorhexidine wipes does not reduce maternal and perinatal mortality or neonatal sepsis. The finding of reduced superficial skin infections on day 7 without change in sepsis or mortality suggests that this difference, although statistically significant, may not be of major importance. LEVEL OF EVIDENCE: I.

Indexed as

AdultAnti-Infective Agents, LocalChlorhexidineDeveloping CountriesFemaleHumansInfant, NewbornInfant, Newborn, DiseasesPakistanPregnancySepsisYoung AdultAnti-Infective Agents, LocalChlorhexidine

Identifiers

PMID20502294
PMCPMC3893917
OpenAlexW2031110463

What OpenQuestion holds

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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.