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

Objective To determine whether treatment with ampicillin and metronida zole in women with threatened idiopathic preterm labour will prolong t he gestation and reduce maternal and neonatal infectious morbidity. De sign Randomised controlled double-blind trial. Setting Six obstetric d epartments in the Copenhagen area. Population One hundred and twelve w omen with singleton pregnancies, with threatened idiopathic preterm la bour and intact amniotic membranes at 26 to 34 weeks of gestation. Met hods Random allocation to eight days intravenous and oral treatment wi th ampicillin and metronidazole, or placebo. Main outcome measures Num ber of days from admission to delivery, gestational age at delivery, r ates of preterm delivery, low birthweight, maternal infections and neo natal infections. Results Treatment with ampicillin and metronidazole was associated with a significant prolongation of pregnancy (admission to delivery 47.5 days versus 27 days, P < 0.05), higher gestational a ge at delivery (37 weeks versus 34 weeks, P < 0.05), decreased inciden ce of preterm birth (42% versus 65%, P < 0.05), and lower rate of admi ssion to neonatal intensive care unit (40% versus 63%, P < 0.05), when compared with placebo treatment. Antibiotic treatment had no signific ant effects on infectious morbidity. Conclusions Treatment with ampici llin and metronidazole in women with threatened idiopathic preterm lab our significantly prolonged the gestation, but had no effects on mater nal and neonatal infectious morbidity.