Ampicillin and metronidazole treatment in preterm labour: a multicentre, randomised controlled trial.
OBJECTIVE
To ascertain whether adjuvant ampicillin and metronidazole given to women in preterm labour with intact membranes would prolong pregnancy and decrease the perinatal mortality and morbidity.


METHODS
A multicentre, prospective, randomised controlled trial.


METHODS
Three perinatal centres serving an indigent population.


METHODS
Eighty-one women in active preterm labour with otherwise uncomplicated singleton pregnancies between 26 and 34 weeks gestation or an ultrasound fetal weight estimate of 800 g to 1500 g.


METHODS
The study group received ampicillin and metronidazole for five days. The control group received no antibiotics. In all women contractions were suppressed with hexoprenaline and indomethacin for 24 h, and betamethasone was given for fetal lung maturity.


METHODS
Days gained and perinatal mortality and morbidity.


RESULTS
The study (n = 43) and control groups (n = 38) were comparable at entry. In those receiving ampicillin and metronidazole the pregnancy was significantly prolonged (median 15 days versus 2.5 days, P = 0.04) with significantly more women still pregnant 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 necrotising enterocolitis than in the study group (5 versus 0, P = 0.02).


CONCLUSIONS
Adjuvant ampicillin and metronidazole in the management of women in preterm labour with intact membranes significantly prolonged the pregnancy and decreased neonatal morbidity.
MRC Perinatal Mortality Research Unit, Tygerberg Hospital, Cape Province, South Africa.
K
K
Norman
R C
RC
Pattinson
J
J
de Souza
P
P
de Jong
G
G
Moller
G
G
Kirsten
D000328:Adult; D000667:Ampicillin / Q000627:therapeutic use*; D001724:Birth Weight; D004359:Drug Therapy, Combination; D005260:Female; D005865:Gestational Age; D006801:Humans; D008795:Metronidazole / Q000627:therapeutic use*; D007752:Obstetric Labor, Premature / Q000401:mortality / Q000517:prevention & control*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D013997:Time Factors
D008795:Metronidazole; D000667:Ampicillin