The ORACLE trial evaluated antibiotics in preterm prelabour rupture of membranes (PPROM). Which antibiotic regimen was found to be harmful (increasing necrotizing enterocolitis risk in the neonate) and should NOT be used in PPROM?
- A Co-amoxiclav (amoxicillin-clavulanate) with or without erythromycin ✓
- B Erythromycin alone
- C Azithromycin alone
- D Cephalexin alone
Explanation
The ORACLE I trial showed that erythromycin alone prolonged pregnancy and improved neonatal outcomes in PPROM. However, co-amoxiclav (amoxicillin + clavulanic acid), either alone or combined with erythromycin, was associated with a significantly higher rate of neonatal necrotizing enterocolitis (NEC)—proposed to be due to the clavulanic acid component altering gut microbiome. Current UK RCOG and NICE guidelines recommend erythromycin (250 mg 4× daily for 10 days) as the antibiotic of choice in PPROM and specifically contraindicate co-amoxiclav. In penicillin-allergic patients, erythromycin remains the first choice. ORACLE II in spontaneous preterm labor without ruptured membranes showed no benefit from antibiotics.
Reference: Williams Obstetrics, 26th ed.
High-yield for: NEET PGINI-CETNExTFMGEUSMLEPLABMRCP
Written and medically reviewed by the StethoPrep medical team.