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Therapeutics
Antibiotics did not prevent adverse outcomes after preterm, prelabour rupture of fetal membranes

https://doi.org/10.1136/ebm.6.5.138

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    (2001) Lancet 357, 979. Kenyon SL, Taylor DJ, Tarnow-Mordi W, for the ORACLE Collaborative Group.. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial.. Mar 31;. :. –88.
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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 …

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