OBJECTIVE: To assess tolerance and safety of 0.6% chlorhexidine vaginal and neonatal wipes to improve perinatal outcomes in home deliveries in Pakistan and the ability of traditional birth attendants and project staff to perform a randomized trial of this intervention.
METHODS: Focus groups of pregnant and nonpregnant women and in-depth interviews of traditional birth attendants explored barriers to the use of chlorhexidine wipes. Then, a study was performed of women delivering at home attended by traditional birth attendants. Consenting women were randomly assigned to receive either 0.6% chlorhexidine or saline vaginal and neonatal wipes. Women and their infants were followed up on postpartum days 7, 14, and 28. Acceptability and tolerance of vaginal and neonatal wipes, as well as maternal and neonatal outcomes, were assessed.
RESULTS: The focus groups and interviews indicated that the chlorhexidine intervention would be acceptable to women and their providers. Of the 213 eligible pregnant women approached, 203 (95%) gave informed consent and were enrolled and allocated to groups. Traditional birth attendants had no difficulty administering chlorhexidine vaginal and neonatal wipes in a home setting. Of the 203 births, 103 (51%) of whom received 0.6% chlorhexidine, there were no allergic reactions, vaginal itching, burning, or requests for study termination. Follow-up at 28 days postpartum was more than 95%. Although this study was not powered to show significant differences in neonatal outcomes between treatment groups, the lower rates of some neonatal adverse clinical outcomes in the chlorhexidine group were encouraging.
CONCLUSION: Use of 0.6% chlorhexidine vaginal and neonatal wipes for the prevention of neonatal infection is well-tolerated and seems safe. A trial of this intervention by traditional birth attendants in a home-delivery setting is feasible.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00121394
LEVEL OF EVIDENCE: I
Vaginal and neonatal 0.6% chlorhexidine wipes applied by traditional birth attendants in home settings are well tolerated, and a community-based, randomized trial of this intervention is feasible.
From the 1Aga Khan University, Karachi, Pakistan; 2RTI International, Research Triangle Park, North Carolina; 3National Institute of Child Health and Human Development, Bethesda, Maryland; 4University of Alabama at Birmingham, Birmingham, Alabama; and 5Drexel University College of Medicine, Philadelphia, Pennsylvania.
See related editorial on page 968.
Funded by the NICHD Global Network for Women's Health Research, grants U01 HD040607 and U01 HD040636, and the Bill and Melinda Gates Foundation.
Corresponding author: Robert L. Goldenberg, MD, Drexel University College of Medicine, Department of Obstetrics and Gynecology, 245 North 15th Street, Philadelphia, PA 19102; e-mail: email@example.com.
Financial Disclosure The authors have no potential conflicts of interest to disclose.