Comparative Analysis of Maternal and Neonatal Outcomes Associated with Ampicillin–Azithromycin versus Ampicillin–Cefazolin Regimens in Cases of Preterm Premature Rupture of Membranes: A Randomized Controlled Trial

Background and aims: This study aimed to compare the efficacy of two prophylactic antibiotic regimens—ampicillin plus azithromycin versus ampicillin plus cefazolin—on maternal and neonatal outcomes in women with preterm premature rupture of membranes (PPROM). Methods: In this parallel-group randomized controlled trial, 90 pregnant women with PPROM between 26 and 37 weeks of gestation were randomly assigned to receive either ampicillin with azithromycin or ampicillin with cefazolin. Data on maternal and neonatal outcomes were collected from hospital records and analyzed using SPSS version 26. Results: The baseline characteristics, including maternal age, gestational age, and medical history, were comparable between the two groups. Maternal outcomes, such as leukocytosis, fever, incision discharge, and hematomas, did not demonstrate statistically significant differences between the regimens. Neonatal Apgar scores at 1 and 5 minutes were also similar (P>0.05). However, the duration of amniotic sac rupture was significantly shorter in the ampicillin and cefazolin group (median=12 hours, interquartile range=15) compared to the ampicillin and azithromycin group (median=18 hours, interquartile range=9; P=0.033). Conclusion: While most maternal and neonatal outcomes did not differ significantly between the two regimens, the shorter duration of amniotic sac rupture in the ampicillin and cefazolin group suggests potential advantages in reducing infection risks. Further studies are warranted to validate these findings and to optimize antibiotic regimens for the management of PPROM.