Comparison of azithromycin versus erythromycin on gestation length (prolongation of latency interval) and neonatal outcomes in pregnant women with premature rupture of the membrane: an open-label randomized clinical trial

Background: Premature rupture of membrane (PROM) is an important problem among pregnant women, which leads to maternal and neonatal morbidity.This study was done to compare the efficacy of azithromycin with erythromycin on the pregnancy length and the neonatal adverse effects in mothers with PROM.Materials and Methods: In this open-label randomized clinical trial, 194 pregnant women with PROM who referred to Akbarabadi Hospital were enrolled and randomly assigned to two groups. Group I received oral Azithromycin (1 gr/orally), Abidi Company Iran ) + Ampicillin 2 gram IV )Abidi Company, Iran) every six hours for 48 hours; then, only Amoxicillin 500 mg every eight hours for five days. and group II recived intravenous Erythromycin (Abidi Company, Iran) 400 mg every six hours for seven days + Ampicillin 2 grams IV every six hours for 48 hours, then Amoxicillin 500 mg every six hours for five days Finally the pregnancy length and neonatal adverse effects or neonatal outcomes compared between two groups.Result: There was no significant difference between the groups in mean of pregnancy length (32.5 versus 32.6 weeks, respectively, p=0.757) Also the frequency ofIntraventricular hemorrhage, Necrotizing enterocolitis, Respiratory Distress Syndrome sepsis, icter, oxygen demand, ICU admission, duration of hospitalization in the NICU, and mortality in neonate were same between the groups. The mean of patient satisfaction (by self-report) was 9.8 and 9.5 in group I, II, respectivel (P=0.001).Conclusion: It can be concluded that oral azithromycin and intravenous erythromycin have the same effect on increasing the duration of pregnancy and reducing neonatal complications in women with PROM. But azithromycin was associated with greater satisfaction and its use is recommended.