Study Details
To determine the tolerance of maternal vaginal and infant chlorhexidine washes.
This study is a dosing trial utilizing differing concentrations of chlorhexidine for maternal and infant perinatal washes assessing safety and tolerance.
Subjects were recruited for enrollment in the study during a third trimester antenatal visit at the Chris Hani Baragwanath Hospital maternity unit in Soweto, South Africa, which is a comprehensive prenatal and maternity unit. The study interventions were initiated when the subjects were in active labor and had presented to the maternity clinic.
25 mother/infant pairs with a 0.25% concentration of chlorhexidine
75 mother/infant pairs with a 2% concentration of chlorhexidine
75 mother/infant pairs with a 1% concentration of chlorhexidine (amended from the planned 4% evaluation based on acceptability data from the 2% concentration)
Total enrollment will be 175 and will include both HIV-positive and HIV-negative women.
Follow-up: 2 weeks post-washing.
The study was conducted January-September, 2000.
The interventions took place peripartum and consisted of the following: 1) Cervicovaginal wash of the entire birth canal with the chlorhexidine solution at the time of each vaginal examination of a mother in labor; 2) Immediate suctioning of the nasal and oral passages of the infant at the time the head emerges; and 3) Thorough washing of the baby with the chlorhexidine solution immediately after delivery. The study initially evaluated 2% chlorhexidine concentration. Based on the tolerance and safety profile, as assessed by an internal review group, the study proceeded to test a 1% chlorhexidine concentration, rather than a 4% concentration, as initially planned.
To determine the maximum safe and tolerable concentration of chlorhexidine for peripartum vaginal and postpartum newborn cleansing in the prevention of perinatal transmission of HIV.
To obtain potential biological data (quantitative PCR of oral/nasal suction samples from infants born to HIV-positive women) to support the hypothesis that higher concentrations of chlorhexidine will be effective in reducing perinatal transmission of HIV.