AMPICILLIN AND METRONIDAZOLE TREATMENT IN PRETERM LABOR - A MULTICENTER, RANDOMIZED CONTROLLED TRIAL

Objective To ascertain whether adjuvant ampicillin and metronidazole g iven to women in preterm labour with intact membranes would prolong pr egnancy and decrease the perinatal mortality and morbidity. Design A m ulticentre, prospective, randomised controlled trial. Setting Three pe rinatal centres serving an indigent population. Subjects Eighty-one wo men in active preterm labour with otherwise uncomplicated singleton pr egnancies between 26 and 34 weeks gestation or an ultrasound fetal wei ght estimate of 800 g to 1500 g. Interventions The study group receive d ampicillin and metronidazole for five days. The control group receiv ed no antibiotics. In all women contractions were suppressed with hexo prenaline and indomethacin for 24 h, and betamethasone was given for f etal lung maturity. Main outcome measures Days gained and perinatal mo rtality and morbidity. Results The study (n = 43) and control groups ( n = 38) were comparable at entry. In those receiving ampicillin and me tronidazole the pregnancy was significantly prolonged (median 15 days versus 2.5 days, P = 0.04) with significantly more women still pregnan t after seven days (63% versus 37%, P = 0.03, OR 0.34 95% CI 0.13-0.94 ). Significantly more infants in the control group developed necrotisi ng enterocolitis than in the study group (5 versus 0, P = 0.02). Concl usion Adjuvant ampicillin and metronidazole in the management of women in preterm labour with intact membranes significantly prolonged the p regnancy and decreased neonatal morbidity.