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

Abstract

UNLABELLED:

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.

• Authors: S Kenyon, D J Taylor, W O Tarnow-Mordi, ORACLE Collaborative Group
• Journal: Acta paediatrica (Oslo, Norway : 1992). Supplement (Acta Paediatr Suppl) Vol. 91 Issue 437 Pg. 12-5 ( 2002) ISSN: 0803-5326 [Print] Norway
• PMID: 12200889 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Erythromycin
• Amoxicillin-Potassium Clavulanate Combination

Topics

• 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, prevention & control)
• Follow-Up Studies
• Humans
• Infant, Newborn
• Pregnancy
• Pregnancy Outcome
• Reference Values
• Risk Assessment
• Treatment Outcome