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

Abstract

Objective: Our purpose was to test the efficacy of antibiotic prophylaxis in women with preterm premature rupture of the membranes who receive antenatal corticosteroids.

Study design: 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.

Results: 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).

Conclusions: 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 and significantly increased birth weight compared with corticosteroids alone.