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Therapeutics
Antibiotics did not prevent adverse outcomes in women in preterm labour with intact fetal membranes

https://doi.org/10.1136/ebm.6.5.139

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    (2001) Lancet 357, 989. Kenyon SL, Taylor DJ, Tarnow-Mordi W, for the ORACLE Collaborative Group.. Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial.. Mar 31;. :. –94.
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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, …

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    Footnotes

    • 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.

    • For correspondence: Ms S Kenyon, Department of Obstetrics and Gynaecology, Robert Kilpatrick Building, Leicester Royal Infirmary, P.O. Box 65, Leicester LE2 7LX, UK. Fax +44 (0)116 252 3154.

    • ↵* See glossary.

    • ↵† Information provided by author.