Antenatal azithromycin to prevent preterm birth in pregnant women with vaginal cerclage: A randomized clinical trial

OBJECTIVE: To assess whether antenatal azithromycin given to pregnant women with vaginal cerclage can reduce preterm birth or not. MATERIALS AND METHODS: We randomized 50 pregnant ladies who underwent cerclage at Ain Shams University Maternity Hospital in group A (receiving 500 mg Azithromycin oral tablets (Zithrokan(®), Hikma, Egypt) one tablet orally twice daily for three days in 3 courses at 14(th), 24(th) and 32(nd) week, plus usual antenatal care) and an identical group B (receiving usual antenatal care). Our primary outcome was gestational age at delivery, and secondary outcomes were birthweight, mode of delivery, and maternal, and perinatal complications. This study was registered on ClinicalTrials.gov with number: NCT04278937. RESULTS: Pregnancy was more prolonged in the Azithromycin group (delivery at 36.8 weeks vs 34.1 weeks; p=0.017). Also, a higher birthweight was observed in the Azithromycin group (2932.6 gm vs 2401.8 gm; p=0.006). No significant difference was found between the two groups as regards to other outcomes (miscarriage, stillbirth, neonatal intensive care unit admission, antepartum hemorrhage, postpartum pyrexia, need for blood transfusion). CONCLUSION: Adding antenatal azithromycin to women undergoing cerclage prolongs pregnancy and reduces the risk of preterm birth, with a slight increase in birthweight.