OBJECTIVE: To determine whether prophylactic antibiotic administration in women presenting with premature rupture of membranes (PROM) at term can alter the rates of maternal and neonatal infections. METHODS: In a randomized, controlled, nonblinded trial, women at low risk with singleton term pregnancies presenting with PROM were assigned to either antibiotic administration or no treatment. Main outcomes evaluated were rates of maternal infection (chorioamnionitis and endometritis) and neonatal infection. RESULTS:A total of 161 patients were evaluated, 78 in the antibiotic group and 83 in the control group. Maternal infection was significantly lower when antibiotics were administered (2.6% compared with 13.2%; relative risk 0.89, 95% confidence interval 0.81-0.98; P=.013). All cases of maternal infection occurred in women with more than 12 hours of PROM. Newborns of mothers receiving antibiotics had fewer infections (3.8%) compared with those in the control group (6.0%), but the difference was not statistically significant (P=.375). CONCLUSION: Prophylactic use of antibiotics in PROM at term significantly reduced the risk of maternal infection in our population. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01633294. LEVEL OF EVIDENCE: I.
RCT Entities:
OBJECTIVE: To determine whether prophylactic antibiotic administration in women presenting with premature rupture of membranes (PROM) at term can alter the rates of maternal and neonatal infections. METHODS: In a randomized, controlled, nonblinded trial, women at low risk with singleton term pregnancies presenting with PROM were assigned to either antibiotic administration or no treatment. Main outcomes evaluated were rates of maternal infection (chorioamnionitis and endometritis) and neonatal infection. RESULTS: A total of 161 patients were evaluated, 78 in the antibiotic group and 83 in the control group. Maternal infection was significantly lower when antibiotics were administered (2.6% compared with 13.2%; relative risk 0.89, 95% confidence interval 0.81-0.98; P=.013). All cases of maternal infection occurred in women with more than 12 hours of PROM. Newborns of mothers receiving antibiotics had fewer infections (3.8%) compared with those in the control group (6.0%), but the difference was not statistically significant (P=.375). CONCLUSION: Prophylactic use of antibiotics in PROM at term significantly reduced the risk of maternal infection in our population. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01633294. LEVEL OF EVIDENCE: I.