Broad-spectrum antibiotics for spontaneous preterm labour: The ORACLE II randomised trial

S. L. Kenyon, D. J. Taylor, W. Tarnow-Mordi, Rebecca Smyth (Collaborator)

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Background: Preterm birth after spontaneous preterm labour is associated with death, neonatal disease, and long-term disability. Previous small trials of antibiotics for spontaneous preterm labour have reported inconclusive results. We did a randomised multicentre trial to resolve this issue. Methods: 6295 women in spontaneous preterm labour with intact membranes and without evidence of clinical infection were randomly assigned 250 mg erythromycin (n=1611), 325 mg co-amoxiclav (250 mg amoxicillin and 125 mg clavulanic acid; n=1550), both (n=1565), or placebo (n=1569) four times daily for 10 days or until delivery, whichever occurred earlier. The primary outcome measure was a composite of neonatal death, chronic lung disease, or major cerebral abnormality on ultrasonography before discharge from hospital. Analysis was by intention to treat. Findings: None of the trial antibiotics was associated with a lower rate of the composite primary outcome than placebo (erythromycin 90 [5.6%], co-amoxiclav 76 [5.0%], both antibiotics 91 [5.9%], vs placebo 78 [5.0%]). However, antibiotic prescription was associated with a lower occurrence of maternal infection. Interpretation: This trial provides evidence that antibiotics should not be routinely prescribed for women in spontaneous preterm labour without evidence of clinical infection.
    Original languageEnglish
    Pages (from-to)989-994
    Number of pages5
    JournalThe Lancet
    Volume357
    Issue number9261
    DOIs
    Publication statusPublished - 31 Mar 2001

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