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


CONCLUSIONS
Prophylactic antibiotics can play a role in preterm prelabour rupture of the membranes in reducing infant morbidity.
ORACLE Clinical Co-ordinating Centre, Department of Obstetrics, Clinical Sciences Building, Leicester Royal Infirmary, PO Box 65, Leicester LE2 7LX, UK. oracle@ie.ac.uk
S
S
Kenyon
D J
DJ
Taylor
W O
WO
Tarnow-Mordi
D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000008:administration & dosage*; D004917:Erythromycin / Q000008:administration & dosage*; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000188:drug therapy* / Q000517:prevention & control; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011256:Pregnancy Outcome; D012016:Reference Values; D018570:Risk Assessment; D016896:Treatment Outcome
D004917:Erythromycin; D019980:Amoxicillin-Potassium Clavulanate Combination