Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group.

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.

• Authors: S L Kenyon, D J Taylor, W Tarnow-Mordi, ORACLE Collaborative Group
• Journal: Lancet (London, England) (Lancet) Vol. 357 Issue 9261 Pg. 989-94 (Mar 31 2001) ISSN: 0140-6736 [Print] England
• PMID: 11293641 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Erythromycin
• Amoxicillin-Potassium Clavulanate Combination

Topics

• Adult
• Amoxicillin-Potassium Clavulanate Combination (therapeutic use)
• Anti-Bacterial Agents (therapeutic use)
• Drug Therapy, Combination (therapeutic use)
• Drug Utilization
• Enterocolitis, Necrotizing (chemically induced)
• Erythromycin (therapeutic use)
• Female
• Humans
• Infant, Newborn
• Obstetric Labor, Premature (drug therapy)
• Pregnancy
• Pregnancy Outcome (epidemiology)
• Treatment Outcome