Antibiotic prophylaxis in prelabor spontaneous rupture of fetal membranes at or beyond 36 weeks of pregnancy.

ABSTRACT

OBJECTIVE: To assess the effectiveness of prophylactic antibiotics compared with placebo in preventing neonatal and maternal infection-related morbidity associated with prelabor spontaneous rupture of membranes at or beyond 36 weeks of pregnancy. METHODS: In the present randomized controlled trial conducted during 2009-2011, 1640 women with prelabor spontaneous rupture of fetal membranes at or beyond 36 weeks of pregnancy were randomly assigned to receive a single dose of prophylactic intravenous antibiotics or placebo on admission to the labor ward of Ain Shams University, Cairo, Egypt. The participants, caregivers, and investigators were blinded to the group assignment. The primary outcome measure was early-onset neonatal sepsis. An intention-to-treat analysis was performed. RESULTS: Early-onset neonatal sepsis occurred in 34 (4.1%) and 24 (2.9%) neonates in the antibiotics and placebo groups, respectively (risk ratio 1.42; 95% confidence interval 0.85-2.37). Maternal infection outcomes were not significantly different between the 2 trial arms. CONCLUSION: The routine use of prophylactic antibiotics in women with prelabor spontaneous rupture of fetal membranes at or beyond 36 weeks of pregnancy does not reduce the risk of neonatal and maternal infection-related morbidity.