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QUESTION: In pregnant women with preterm, prelabour rupture of fetal membranes (pPROM), are antibiotics better than placebo for preventing neonatal death, chronic lung disease, or major cerebral abnormality before discharge?
Design
Randomised {allocation concealed*}†, blinded (patients and clinicians {outcome assessors and statisticians}†),* placebo controlled trial with a median follow up of 4 days.
Setting
161 centres in 15 countries.
Patients
4826 pregnant women who had fetuses that were <37 weeks of gestation, had pPROM, and had an uncertain need for antibiotics. Women who would have immediate or unstoppable delivery or who had fetuses not premature enough to warrant concern, had medical or drug contraindications, were prescribed antibiotics, or who were to be prescribed antibiotics for infection were excluded. 4809 women (mean age 28 y) were studied after exclusion of 15 women for protocol violations and 2 women for loss to follow up.
Intervention
1197 women were allocated to erythromycin, 250 mg; 1212 were allocated to co-amoxiclav, 325 …
Footnotes
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Sources of funding: UK Medical Research Council. Co-amoxiclav (Augmentin) and co-amoxiclav placebo were supplied by SmithKline Beecham; erythromycin (Erymax) and erythromycin placebo were supplied by Parke Davis.
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For correspondence: Ms S Kenyon, Department of Obstetrics and Gynaecology, Robert Kilpatrick Building, Leicester Royal Infirmary, PO Box 65, Leicester LE2 7LX, UK. Fax +44 (0)116 252 3154.
↵† Information provided by author.