A PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, CONTROLLED CLINICAL-TRIAL OFAMPICILLIN-SULBACTAM FOR PRETERM PREMATURE RUPTURE OF MEMBRANES IN WOMEN RECEIVING ANTENATAL CORTICOSTEROID-THERAPY

OBJECTIVE: Our purpose was to test the efficacy of antibiotic prophyla xis in women with preterm premature rupture of the membranes who recei ve antenatal corticosteroids. STUDY DESIGN: A total of 112 women recei ved one of three regimens in a double-blind randomized controlled tria l: (1) ampicillin-sulbactam for 72 hours followed by amoxicillin-clavu lanate, (2) ampicillin for 72 hours followed by amoxicillin, or (3) pl acebo. RESULTS: A total of 48.6% of neonates in the placebo group eith er died or had sepsis or respiratory distress syndrome versus 29.3% in the pooled antibiotic group (p < 0.05) and 26.3% in the ampicillin-su lbactam/amoxicillin-clavulanate subgroup (p < 0.05). Ail three neonata l deaths occurred in the placebo group (p = 0.03 versus pooled antibio tics). Mean birth weight was significantly greater in the pooled antib iotic group (1773 gm, p = 0.04) and in the ampicillin-sulbactam/amoxic illin-clavulanate subgroup (1870 gm, p = 0.02) than in the placebo gro up (1543 gm). Antibiotic prophylaxis reduced the need for prolonged ve ntilation (p = 0.05). CONCLUSIONS: Antibiotic prophylaxis in combinati on with corticosteroids in preterm premature rupture of membranes sign ificantly lowered the total frequency of neonatal mortality, sepsis, a nd respiratory distress syndrome and significantly increased birth wei ght compared with corticosteroids alone.