A prospective, double-blind, randomized, controlled clinical trial of ampicillin-sulbactam for preterm premature rupture of membranes in women receiving antenatal corticosteroid therapy

American Journal of Obstetrics and Gynecology
S M LovettT J Garite

Abstract

Our purpose was to test the efficacy of antibiotic prophylaxis in women with preterm premature rupture of the membranes who receive antenatal corticosteroids. A total of 112 women received one of three regimens in a double-blind randomized controlled trial: (1) ampicillin-sulbactam for 72 hours followed by amoxicillin-clavulanate, (2) ampicillin for 72 hours followed by amoxicillin, or (3) placebo. A total of 48.6% of neonates in the placebo group either 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-sulbactam/amoxicillin-clavulanate subgroup (p < 0.05). All three neonatal deaths occurred in the placebo group (p = 0.03 versus pooled antibiotics). Mean birth weight was significantly greater in the pooled antibiotic group (1773 gm, p = 0.04) and in the ampicillin-sulbactam/amoxicillin-clavulanate subgroup (1870 gm, p = 0.02) than in the placebo group (1543 gm). Antibiotic prophylaxis reduced the need for prolonged ventilation (p = 0.05). Antibiotic prophylaxis in combination with corticosteroids in preterm premature rupture of membranes significantly lowered the total frequency of neonatal mortality, sepsis, and respiratory distress syndrome a...Continue Reading

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