Chlorhexidine washing of the vagina in labor and neonate after birth: An RCT by the global network for perinatal & reproductive health

Abstract

BIRTH: AN RCT BY THE GLOBAL NETWORK FOR PERINATAL & REPRODUCTIVE HEALTH LEONARDO PEREIRA, TSUNGAI CHIPATO, ALEXIO MASHU, VELDA MUSHANGWE, SIMBARASHE RUSAKANIKO, SHRIKANT BANGDIWALA, OFFICE CHIDEDE, GARY DARMSTADT, SIMON MADZIME, G. KANDAWASWIKA, PISAKE LUMBIGANON, JORGE E TOLOSA, Oregon Health & Science University, Global Network for Perinatal and Reproductive Health, Obstetrics and Gynecology, Portland, Oregon, University of Zimbabwe, Harare, Zimbabwe, University of North Carolina at Chapel Hill, Biostatistics, Chapel Hill, North Carolina, Johns Hopkins University, International Health, Baltimore, Maryland, Khon Kaen University, Obstetrics & Gynecology, Khon Kaen, Thailand OBJECTIVE: To determine the safety and acceptability of 1% chlorhexidine (CHX) vaginal washing of the vagina in labor and of the neonate after delivery. STUDY DESIGN: RCT of 1% CHX vaginal and neonatal wash compared to usual care (no wash) (UC) in Harare Central Hospital (HCH), Harare, Zimbabwe from Jan-Nov 2005. IRB approved and written informed consent was obtained in all patients. Cervical exams were performed every 2 hours in all patients per HCH labor protocol. Patients randomized to CHX received vaginal washing at study entry and at 2-hour intervals with each vaginal exam. CHX washing was: (1) vulvar wiping with a 4x4cm CHX-soaked cotton ball (15-20ml of CHX) and (2) vaginal wash with a 4x4cm CHX-soaked cotton ball. Mothers were observed for the development of skin rash and asked about symptoms of vaginal burning. The neonate was cleansed immediately following birth with CHX-soaked cotton balls (excluding the head). Axillary neonatal temperature was recorded before and after the wash. All neonates were observed for skin rash/irritation by a pediatrician blinded to randomization status. Health care providers, blinded to randomization status, followed neonates and mothers at neonatal days of life 7 and 28. RESULTS: 502 women enrolled with a 2:1 randomization: 334 CHX group and 168 UC. Maternal age, gravidity, smoking status, and GA at enrollment did not differ between groups. No cases of maternal rash or vaginal burning were reported. Women in the CHX group received a mean of 2.6 G SD 1.3 vaginal washings. None of the neonates developed axillary temp !35(C; only 2.4% of neonates had a temperature drop O1(C after CHX wash; 1 minor neonatal skin rash. 7-day follow up was 66.9%, while 28-day follow up was 56.4%. Operation Murambatsvina (‘‘Restore Order’’) a government relocation plan in Zimbabwe resulted in significant displacement of subjects during the study. CONCLUSION: The use of 1% CHX vaginal and neonatal washing is safe for mothers and neonates and accepted by Labor ward staff. An RCT powered for reduction in neonatal mortality is urgently needed.