Original Research|Articles in Press, 100900

Compared perinatal outcomes of two prophylactic antibiotic regimens for preterm pre-labor rupture of membranes: A randomized controlled trial

Published:February 13, 2023DOI:



      Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated with significantly-reduced intra-amniotic infection and improved neonatal outcome, although data are insufficient to determine the optimal antibiotic regimen. Ampicillin resistance has changed the epidemiology of neonatal sepsis.


      We compared the efficacy of two antibiotic regimens in prolonging the latency period in women with PPROM.

      Study Design

      This randomized-controlled trial was conducted in three tertiary university-affiliated hospitals; 124 women with PPROM<37 weeks were randomized into two antibiotic prophylactic protocols: ampicillin + roxithromycin vs. cefuroxime + roxithromycin. We measured and compared latency period length, neonatal adverse outcomes and maternal infectious morbidity including intrauterine infection, intrapartum fever, postpartum antibiotic treatment, endometritis and wound infection.


      Maternal infectious morbidity was higher in the ampicillin versus cefuroxime group (17.7% versus 6.5%, p-value one sided=0.048). The pathogen distribution among placenta, membrane, cord and uterine cultures differed between the groups (p=0.017). Enterobacteriaceae spp. cultures were identified in 68.6% of the cultures in the ampicillin group versus 43.2% in the cefuroxime group (p=0.036). The composite neonatal adverse outcome was higher in the ampicillin than the cefuroxime group: 55 (88.7%) versus 46 (74.2%), p-value one-sided=0.03. The proportion of primiparas with a latency period above 4 days was significantly higher in the cefuroxime versus the ampicillin group (P=0.025, OR=3.69 95% CI (1.175,11.607)).


      In combination with roxithromycin, cefuroxime compared to ampicillin, as a prophylactic for PPROM<37, showed longer pregnancy in primiparas and less maternal and neonatal morbidity. Further larger studies are needed to support our results.


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