OBJECTIVE: The purpose of this study was to determine whether intrapartum chlorhexidine vaginal irrigations prevent peripartal infection in nulliparous women at >or=32 weeks of gestation. STUDY DESIGN: This was a double-blinded, placebo-controlled randomized clinical trial. Vaginal irrigations were performed with 200 mL of 0.2% chlorhexidine solution or sterile saline solution placebo every 6 hours during labor. The primary study outcome was clinically diagnosed maternal peripartal infection: chorioamnionitis or endometritis. Analysis was by intent to treat. RESULTS:One thousand forty-one women were assigned randomly to one of two groups (chlorhexidine therapy, 525 women; placebo, 516 women). The two groups were balanced for risk factors for infection. Rates of peripartal infection were 19.3% in the chlorhexidine group and 17.3% in the placebo group (relative risk 1.1; 95% CI, 0.9-1.4). Major and minor neonatal morbidities were similar between the groups. No major and one minor adverse reaction was attributed to chlorhexidine irrigation. CONCLUSION: Under the conditions of this trial, chlorhexidine vaginal irrigation lacked efficacy in the prevention of clinically diagnosed maternal and neonatal infectious morbidity.
RCT Entities:
OBJECTIVE: The purpose of this study was to determine whether intrapartum chlorhexidine vaginal irrigations prevent peripartal infection in nulliparous women at >or=32 weeks of gestation. STUDY DESIGN: This was a double-blinded, placebo-controlled randomized clinical trial. Vaginal irrigations were performed with 200 mL of 0.2% chlorhexidine solution or sterile saline solution placebo every 6 hours during labor. The primary study outcome was clinically diagnosed maternal peripartal infection: chorioamnionitis or endometritis. Analysis was by intent to treat. RESULTS: One thousand forty-one women were assigned randomly to one of two groups (chlorhexidine therapy, 525 women; placebo, 516 women). The two groups were balanced for risk factors for infection. Rates of peripartal infection were 19.3% in the chlorhexidine group and 17.3% in the placebo group (relative risk 1.1; 95% CI, 0.9-1.4). Major and minor neonatal morbidities were similar between the groups. No major and one minor adverse reaction was attributed to chlorhexidine irrigation. CONCLUSION: Under the conditions of this trial, chlorhexidine vaginal irrigation lacked efficacy in the prevention of clinically diagnosed maternal and neonatal infectious morbidity.
Authors: Sarah Saleem; Dwight J Rouse; Elizabeth M McClure; Anita Zaidi; Tahira Reza; Y Yahya; I A Memon; N H Khan; G Memon; N Soomro; Omrana Pasha; Linda L Wright; Janet Moore; Robert L Goldenberg Journal: Obstet Gynecol Date: 2010-06 Impact factor: 7.661
Authors: E M McClure; R L Goldenberg; N Brandes; G L Darmstadt; L L Wright; Deborah Armbruster; Robert Biggar; Joyce Carpenter; Michael J Free; Donald Mattison; Matthews Mathai; Nancy Moss; Luke C Mullany; Stephanie Schrag; James Tielsch; Jorge Tolosa; Stephen N Wall; Anne Schuchat; Abdelkrim Smine Journal: Int J Gynaecol Obstet Date: 2007-03-30 Impact factor: 3.561