Perinatal intervention trial in Africa: effect of a birth canal cleansing intervention to prevent HIV transmission.

ABSTRACT

PIP: In light of evidence that birth canal exposure to HIV may be a major means of maternal-fetal transmission of the infection, a clinical trial was performed to determine the safety and efficacy of cleansing the birth canal with a cotton pad soaked in 0.25% chlorhexidine. This cleansing took place on admission in labor and every four hours until delivery. After a pilot study in 160 women ensured the safety of the procedure, the study was designed so that all women giving birth in June, July, and November 1994 were part of the control group and those giving birth from August to October were assigned to the intervention group. The mother's HIV status was established, and infants were seen at 6 and 12 weeks postpartum. After adjustment of the sample, data were analyzed on 3327 controls and 3637 cases. 2094 of the total enrolled were infected with HIV. Of these, 59% brought their infants to follow-up at least once as did 61.5% of the mothers who were not infected. The mother-to-infant transmission rate in this study was 27.4%. There was no evidence that the intervention prevented transmission. The only case in which washing reduced transmission rates was in babies born to women whose membranes were ruptured for more than four hours before delivery (in these, the transmission rate was significantly lower in intervention women [25%] than in control women [39.4%]). This result points to a role for ascending infection, but, if this were the case, washing before rupture of the membranes should have and did not reduce risk. Possible reasons for the failure of this intervention are that there may have been inadequate cleansing, the chlorhexidine solution may have been too weak, or the role of birth canal exposure in transmitting the infection may be less than previously believed. It is also difficult to quantify peripartum transmission in infants who are breast fed. The multiple modes by which infection may be transmitted will make it difficult to discover a simple, effective, and affordable way to reduce maternal-child transmission in developing countries.