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ORACLE—antibiotics for preterm prelabour rupture of the membranes: short‐term and long‐term outcomes
Author(s) -
Kenyon S,
Taylor DJ,
TarnowMordi WO
Publication year - 2002
Publication title -
acta pædiatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/j.1651-2227.2002.tb00153.x
Subject(s) - medicine , erythromycin , rupture of membranes , placebo , randomized controlled trial , pediatrics , antibiotics , pregnancy , surgery , gestational age , genetics , alternative medicine , pathology , microbiology and biotechnology , biology
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 coamoxiclav 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.