Chlorhexidine Vaginal and Infant Wipes to Reduce Perinatal Mortality and Morbidity

Abstract

Background Sepsis is a leading cause of perinatal death in developing countries. Vaginal organisms acquired during labor play a significant role. Prior studies suggest that chlorhexidine wiping of the maternal vagina during labor and of the neonate may reduce peripartum infections. 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. Findings From 2005 to 2008, 5,008 laboring women and their neonates were randomized 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% vs. 3.4%; RR 0.91, 95% CI 0.67, 1.24), as was the composite rate of neonatal sepsis or 28-day perinatal mortality, (3.8% vs. 3.9%, RR 0.96, 95% CI 0.73, 1.27). At day 7, the chlorhexidine group had a lower rate of neonatal skin infection. (3.3 vs. 8.2%, p<0.0001) With the exception of less frequent 7-day hospitalization in the chlorhexidine group, there were no significant differences in maternal outcomes between the groups. Interpretation This trial provides evidence that the use of 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. Trial Registration: Clinicaltrials.gov: NCT00121394

Adverse neonatal and maternal outcomes in Pakistani tertiary care hospitals: A prospective, observational study

“…Care practices involving the umbilical stump and skin were generally appropriate, but those infants that did not receive cord care or cleansing had worse outcomes. Recent papers suggest that 4% chlorhexidine cord treatment may play an important role in reducing omphalitis and subsequent systemic infections [26,[33][34][35]. Most women reported washing their hands prior to eating or after using the toilet, but those that did not had worse outcomes.…”

“…From 2005 to 2008, three large tertiary level hospitals serving the poor, urban population of Karachi, Pakistan participated in a randomized controlled trial of chlorhexidine vaginal and infant wipes [26]. Each woman in the treatment group received a vaginal wipe with 0.6% chlorhexidine in labor and the newborn was wiped with chlorhexidine after birth.…”

“…To do this, we conducted secondary analyses of data collected as part of a randomized trial of chlorhexidine vaginal wipes during labor and infant wipes immediately after delivery to prevent perinatal morbidity and mortality [26].…”

Colonización e infección en el neonato. ¿Hay un rol para el uso de la clorhexidina en la prevención de infecciones?

“…En estudios clínicos analíticos, los apósitos utilizados para cubrir las inserciones de los catéteres percutáneos a base de clorhexidina han reportado dermatitis de contacto en porcentajes cercanos al 5,7% en pacientes menores de 26 semanas 31 La frecuencia del exantema varía por factores, como la edad gestacional, la hipersensibilidad de la piel y las diferentes concentraciones de clorhexidina usadas, pero, en general, puede existir en el 5% de todos los recién nacidos y en el 15% de los prematuros < 1000 gramos y < 28 semanas 25 Estudios cuya intervención principal ha sido la limpieza corporal total con clorhexidina no evidencian un aumento significativo en el riesgo de presentar exantema en neonatos con el uso de clorhexidina 0,6% en agua estéril. 32 No es clara la evidencia de los efectos derivados de la acumulación en la sangre de niños sometidos a la limpieza diaria con paños impregnados en clorhexidina. No es posible comparar los estudios existentes en la literatura porque no se ha realizado un ensayo que tenga estandarizada la toma de muestras.…”

Colonization and infection in the newborn infant: Does chlorhexidine play a role in infection prevention?

“…25 Studies that used whole-body chlorhexidine bathing as the main intervention did not evidence a significant increase in the risk of exanthema in newborn infants using 0.6% chlorhexidine in sterile water. 32 The evidence regarding the side effects of buildup in the blood of infants cleansed with chlorhexidine-impregnated cloths on a daily basis is not clear. It is not possible to compare studies available in the literature because no trial has been conducted using standardized sampling.…”