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


RESULTS
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.


CONCLUSIONS
This trial provides evidence that antibiotics should not be routinely prescribed for women in spontaneous preterm labour without evidence of clinical infection.
Kenyon
S L
SL
Department of Obstetrics and Gynaecology, Leicester Royal Infirmary, UK. oracle@le.ac.uk
Taylor
D J
DJ
Tarnow-Mordi
W
W
D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D004363:Drug Utilization; D020345:Enterocolitis, Necrotizing / Q000139:chemically induced; D004917:Erythromycin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007752:Obstetric Labor, Premature / Q000188:drug therapy*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D004917:Erythromycin; D019980:Amoxicillin-Potassium Clavulanate Combination