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QUESTION: For pregnant women in preterm labour with intact fetal membranes, 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 3 days.
Setting
161 centres in 15 countries.
Patients
6295 pregnant women who had fetuses that were <37 weeks of gestation, who were in suspected or definite preterm labour with intact fetal membranes, and who 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. 6241 women (mean age 26 y) were studied after exclusion of 14 women for protocol violations and 40 women for loss to follow up.
Intervention
1611 women were allocated to erythromycin, …