Document Detail


Chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: a randomized controlled trial.
MedLine Citation:
PMID:  20502294     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To estimate the effects of chlorhexidine vaginal and baby wipes on fetal and neonatal mortality, respectively, and infection-related morbidity.
METHODS: We 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.
RESULTS: From 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.
CONCLUSION: Using 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.
Authors:
Sarah Saleem; 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
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  115     ISSN:  1873-233X     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-05-26     Completed Date:  2010-07-01     Revised Date:  2014-02-28    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1225-32     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00121394
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Infective Agents, Local / therapeutic use*
Chlorhexidine / therapeutic use*
Developing Countries
Female
Humans
Infant, Newborn
Infant, Newborn, Diseases / microbiology,  mortality*,  prevention & control*
Pakistan / epidemiology
Pregnancy
Sepsis / mortality,  prevention & control*
Young Adult
Grant Support
ID/Acronym/Agency:
U01 HD040607/HD/NICHD NIH HHS; U01 HD040607/HD/NICHD NIH HHS; U01 HD040636/HD/NICHD NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Infective Agents, Local; R4KO0DY52L/Chlorhexidine
Comments/Corrections

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