Chlorhexidine Wipes Fail to Prevent Newborn Deaths and Sepsis

Nancy Fowler Larson

June 3, 2010 — Wiping vaginal areas before birth and swabbing newborns with chlorhexidine, an antiseptic solution, do not prevent sepsis (bacterial infection in the blood or tissues) or reduce the mortality rate of mothers or children, according to a study published in the June issue of Obstetrics & Gynecology.
In developed nations, where group B streptococci are most often the trigger for sepsis, antibiotics are showing their effectiveness, but in underdeveloped countries, where sepsis is a chief reason for neonatal death, the cause is more likely to be gram-negative bacteria (Klebsiella pneumonia and Escherichia coli), which may be transmitted during labor from the mother's genital tract to the fetus. No method of prevention has been proven, but antiseptic solutions have held promise.
"It has been proposed that peripartal infection of the fetus and mother may be prevented by intrapartum vaginal and neonatal wipes with an antiseptic solution," write Sarah Saleem, MBBS, from Aga Khan University, Karachi, Pakistan, and colleagues. "One such antiseptic solution is chlorhexidine, which has a wide range of effectiveness against aerobic and anaerobic gram-negative and gram-positive organisms."
The efficacy of chlorhexidine was suggested by a pilot study. Because subsequent research was plagued by methodological weaknesses, the researchers launched their randomized trial to determine the effect of chlorhexidine wipes on mortality of the unborn and newborns and on the morbidity caused by sepsis.
The investigators conducted a study of 5008 women from June 2005 through May 2008 in 3 Karachi hospitals that serve the poor. During this period, 2205 laboring women and their newborns were wiped with chlorhexidine and 2503 were wiped with a saline solution. A field team examined the mothers and infants at home at 7 days and 28 days. The primary outcome was infant death at 7 days or before or the presence of sepsis in living newborns.
There were few distinctions between groups regarding factors including the mother's age, number of previous births, gestational age, type of delivery, birth weight, sex, or Apgar score.
Maternal results revealed no important disparities between groups other than less frequent hospitalizations at 7 days for those who received chlorhexidine. Data on 1596 of the infants (32%) produced the following findings.

• There was little difference between groups regarding primary outcome (3.1% for the chlorhexidine group vs 3.4% for the control group; relative risk [RR], 0.91; 95% confidence interval [CI], 0.67 - 1.24; P = .57).
• No significant differences were found in the composite rate of neonatal sepsis or mortality at 28 days (3.8% vs 3.9%; RR, 0.96; 95% CI, 0.73 - 1.27; P = .79).
• On day 7, a lower rate of infant skin infection was found in the chlorhexidine group (3.3% vs 8.2%; P < .001).

"Using maternal chlorhexidine vaginal wipes during labor and neonatal chlorhexidine wipes does not reduce maternal and perinatal mortality or neonatal sepsis," the authors write. "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."
There were no stated limitations to the study. The investigators encourage further research to diminish the widespread infections in developing countries.
"Despite the failure of chlorhexidine maternal and vaginal wipes to reduce sepsis, infection remains a major cause of neonatal morbidity and mortality in many developing-country settings," the authors write. "Thus, it is important to develop strategies that reduce or prevent newborn bacterial colonization and strategies that reduce death once infection occurs."
The National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research, the Bill and Melinda Gates Foundation, and Aga Khan University supported the study. A complete list of disclosed relevant financial relationships can be found in the article.