J. Svare et al., AMPICILLIN-METRONIDAZOLE TREATMENT IN IDIOPATHIC PRETERM LABOR - A RANDOMIZED CONTROLLED MULTICENTER TRIAL, British journal of obstetrics and gynaecology, 104(8), 1997, pp. 892-897
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.