5450A7

[5450A.7] The Feasibility of Using Vaginal/Neonatal Chlorhexidine (CHX) To Reduce Perinatal Infections, Morbidity and Mortality in Pakistan

Sarah Saleem, Robert L. Goldenberg, Elizabeth M. McClure, Linda L. Wright, Omrana Pasha, Nancy Moss, Dwight J. Rouse. AKU, Karachi, Pakistan; UAB, Birmingham, AL; RTI, Durham, NC; NICHD, Bethesda, MD.

BACKGROUND:
99% of the 4 million neonatal deaths each year occur in developing countries. Where neonatal mortality is very high, studies indicate that infections cause the majority of deaths. CHX, an anti-bacterial agent, acts against a wide range of aerobic and anaerobic Gram negative and positive organisms. Two studies of vaginal CHX wipe in labor with a neonatal wipe have showed promising results in reducing neonatal and maternal mortality and morbidity in developing countries. However, a randomized trial (RCT) of vaginal/neonatal CHX wipe has not yet been done. Nor has its acceptability and effectiveness in a community setting been assessed.

OBJECTIVE:
To evaluate in Pakistan 1) tolerance and acceptability of 0.6% CHX vaginal/ neonatal wipes; 2) feasibility of a RCT of vaginal/neonatal CHX wipes in hospital and home births; and 3) to assess FU at 7, 14 and 28 d post-partum.

DESIGN/METHODS: Focus groups of women, traditional birth attendants (TBAs) and physicians were undertaken. Subsequently, a pilot study of women delivering in two public hospitals in Karachi and in women delivering at home attended by TBAs was launched. Consenting, eligible women are randomized to either 0.6% CHX or saline vaginal/neonatal wipes. Enrolled women and their infants are seen at 7, 14 and 28 d. Monitoring is ongoing.

RESULTS:
Focus groups indicated that CHX use during labor and for the infant would be an acceptable practice in Pakistan. In the pilot study, with nearly 700 hospital and 60 home births, results to date indicate that pregnant laboring women tolerate the intervention well. There have been no allergic reactions to CHX, and no differences in vaginal itching, burning or requests for study termination between the study groups. TBAs have no difficulty in administering the CHX vaginal and baby wipes in a home setting. FU rates in both groups at 28 d post-partum is over 95%.

CONCLUSIONS: We have determined that an RCT of CHX use in labor and in the neonatal period is feasible in Pakistan and that 0.6% CHX applied vaginally is acceptable. As the majority of neonatal deaths worldwide occur in home deliveries, further evaluation of this intervention in a community setting is needed.
Funded by NICHD #U01HD040607, U01HD040636 and the Gates Foundation.

E-PAS2006:59:5450A.7

Tuesday, May 2, 2006 11:45 AM

Platform Session: Neonatal Infectious Diseases in Developing Countries (10:15 AM - 12:15 PM)

Course Number: 5450A