ORACLE--antibiotics for preterm prelabour rupture of the membranes: short-term and long-term outcomes

Acta Paediatr Suppl. 2002;91(437):12-5. doi: 10.1111/j.1651-2227.2002.tb00153.x.

Abstract

Preterm prelabour rupture of the foetal membranes (pPROM) is the most common antecedent of preterm birth and can lead to death, neonatal disease and long-term disability. Previous small trials of antibiotics for pPROM suggested some health benefits for the neonate, but the results were inconclusive. A large, randomized, multicentre trial was undertaken to try to resolve this issue. In total, 4826 women with pPROM were randomized to one of four treatments: 325 mg co-amoxiclav plus 250 mg erythromycin, co-amoxiclav plus erythromycin placebo, erythromycin plus co-amoxiclav placebo, or co-amoxiclav placebo plus erythromycin placebo, four times daily for 10 d or until delivery. The primary outcome measure was a composite of neonatal death, chronic lung disease or major cerebral abnormality on ultrasonography before discharge from hospital. The analysis was undertaken by intention to treat. Indications of short-term respiratory function, chronic lung disease and major neonatal cerebral abnormality were reduced with the prescription of erythromycin. In contrast, the use of co-amoxiclav was associated with a significant increase in the occurrence of neonatal necrotizing enterocolitis.

Conclusion: Prophylactic antibiotics can play a role in preterm prelabour rupture of the membranes in reducing infant morbidity.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Amoxicillin-Potassium Clavulanate Combination / administration & dosage*
  • Antibiotic Prophylaxis*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination / administration & dosage*
  • Erythromycin / administration & dosage*
  • Female
  • Fetal Membranes, Premature Rupture / drug therapy*
  • Fetal Membranes, Premature Rupture / prevention & control
  • Follow-Up Studies
  • Humans
  • Infant, Newborn
  • Pregnancy
  • Pregnancy Outcome*
  • Reference Values
  • Risk Assessment
  • Treatment Outcome

Substances

  • Erythromycin
  • Amoxicillin-Potassium Clavulanate Combination