Safety and Impact of Chlorhexidine Antisepsis Interventions for Improving Neonatal Health in Developing Countries

Luke C. Mullany, PhD; Gary L. Darmstadt, MD; James M. Tielsch, PhD

Disclosures

Pediatr Infect Dis J. 2006;25(8):665-675. 

In This Article

Impact of Chlorhexidine Interventions

Many studies have examined the impact of chlorhexidine interventions on neonatal health. The results and conclusions of these investigations of vaginal, skin, and umbilical cord cleansing are discussed separately below.

GBS Colonization and Infection. GBS is the major cause of early- and late-onset neonatal sepsis in full-term infants in developed countries. Intrapartum chemoprophylaxis and multivalent conjugate vaccines reduce neonatal colonization and the risk of early-onset sepsis.[38] Costs, shifting serotypes, and lack of skilled personnel, however, have impeded widespread implementation of these strategies, particularly in low-resource settings.

Vaginal cleansing with chlorhexidine before or during delivery prevents vertical transfer of GBS to the neonate. The Swedish Chlorhexidine Study Group explored the minimum inhibitory and bactericidal concentrations of chlorhexidine,[39] described postcleansing vaginal concentrations of chlorhexidine and its residual effect on GBS carriage,[40,41] and demonstrated that trace levels of chlorhexidine could be absorbed through the vaginal mucosa.[42] Pilot studies showed that vaginal washing with chlorhexidine reduced newborn colonization with GBS compared with those born to nonwashed controls.[43,44] These studies prompted a series of large randomized controlled trials with varying vaginal cleansing protocols for further exploration of the potential of this intervention to reduce GBS-related neonatal morbidity ( Table 2 ).

Two trials[11,34] demonstrated reductions in vertical transfer of GBS, admissions to the neonatal intensive care unit, and neonatal infections. A third study confirmed that vaginal disinfection reduced GBS colonization of the newborn, but hospital admissions, cases of probable infection, and mortality were equal between the groups.[12] Conducting vaginal examinations during labor using surgical gloves lubricated with 1.0% chlorhexidine digluconate cream did not provide protection against vertical transfer of GBS compared with the use of nonlubricated gloves.[45]

Although these data indicate that vaginal disinfection may reduce neonatal colonization with GBS, the low overall rates of early-onset GBS sepsis has precluded estimation of the impact on newborn infection. None of these studies was conducted in developing countries, and the validity of extrapolating the potential benefit to such settings is problematic. GBS generally has not been identified as a major neonatal pathogen in developing countries, especially in South Asia. In some settings, however, vaginal colonization rates among women are similar to those in industrialized countries.[46] Because the majority of births occur outside of health facilities, the impact of maternal GBS colonization and vertical transfer may be underappreciated, yet further research is required.

Vaginal cleansing with chlorhexidine reduces vertical transmission of GBS to the same degree as intrapartum antibiotics[47] and may be significantly cheaper and easier to implement in settings where skilled providers are lacking. Additionally, the antibacterial action of chlorhexidine extends beyond GBS to a broad spectrum of potentially invasive pathogens. In developing countries where sepsis rates in general are significantly higher, vaginal cleansing interventions have the potential to affect a wider range of neonatal infections.

All-Cause Neonatal Infection. The impact of chlorhexidine-based vaginal cleansing interventions on other neonatal outcomes, including vertical transfer of HIV, newborn bacterial colonization, morbidity, and mortality due to non-GBS pathogens has been studied in both developed and developing countries ( Table 3 ). Five of the studies in Table 3 were conducted in developed countries (United Kingdom, Norway, United States). Stray-Pederson et al[34] found a significant reduction in infectious morbidity (4.9% versus 7.9%, P < 0.05), whereas Calkin[31] found no differences in the rate of admissions to the special-care baby unit among newborns born to chlorhexidine-treated women.

Three other studies from developed countries[32,33,35] focused primarily on maternal outcomes but also reported secondary neonatal outcomes. Details of these studies are found in a Cochrane review[15] on the impact of vaginal cleansing with chlorhexidine on neonatal infection. The low incidence of any type of neonatal infection precluded an accurate estimate of the impact of this intervention, either within studies or when combined in the Cochrane review.[15] In the combined analysis for neonatal sepsis, the relative risk (RR) of infection among the chlorhexidine group was 0.75 (0.17-3.35).[15] Slightly more evidence exists if pneumonia, sepsis, and meningitis infections are combined (RR = 0.54 [0.15-1.97]). Thus, although incidence was low, there was a nonsignificant trend toward more infections in the control groups of these studies ( Table 3 ), suggesting that the utility of this intervention might be examined in low-resource settings where neonates have higher risk of infection and mortality.

Three large studies of vaginal cleansing with chlorhexidine during labor have been undertaken in hospitals in developing countries ( Table 3 ). The original motivation for examining this intervention in sub-Saharan Africa was to prevent mother-to-child transmission of HIV. In a Kenyan hospital, when mothers received vaginal lavage with 0.2% chlorhexidine (later increased to 0.4%), the overall rate of vertical HIV transmission was similar in the intervention and nonintervention periods.[36] These findings were largely consistent with a prior hospital-based study in Malawi.[48] An important difference between the studies was that newborn infants in the intervention arm of the Malawi trial were also given full-body cleansing with 0.25% chlorhexidine. This design, combining both vaginal disinfection and newborn skin cleansing with chlorhexidine and comparing with no intervention, was recently replicated in a hospital in Egypt.[5] These studies and the impact of this dual intervention on neonatal infection and mortality are discussed in more detail in the following section.

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