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


CONCLUSIONS
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.


METHODS
I.
Saleem
Sarah
S
From 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.
Rouse
Dwight J
DJ
McClure
Elizabeth M
EM
Zaidi
Anita
A
Reza
Tahira
T
Yahya
Y
Y
Memon
I A
IA
Khan
N H
NH
Memon
G
G
Soomro
N
N
Pasha
Omrana
O
Wright
Linda L
LL
Moore
Janet
J
Goldenberg
Robert L
RL
D000328:Adult; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D002710:Chlorhexidine / Q000627:therapeutic use*; D003906:Developing Countries; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000382:microbiology / Q000401:mortality* / Q000517:prevention & control*; D010154:Pakistan / Q000453:epidemiology; D011247:Pregnancy; D018805:Sepsis / Q000401:mortality / Q000517:prevention & control*; D055815:Young Adult
D000891:Anti-Infective Agents, Local; D002710:Chlorhexidine