Compared perinatal outcomes of two prophylactic antibiotic regimens for preterm premature rupture of membranes: a randomized controlled trial

BACKGROUND: Prophylactic antibiotic use in preterm premature rup-ture of membranes 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.OBJECTIVE: This study aimed to determine the efficacy of two antibi-otic regimens in prolonging the latency period in women with preterm pre-mature rupture of membranes.STUDY DESIGN: This randomized-controlled trial was conducted in 3 tertiary university-affiliated hospitals. A total of 124 women with preterm premature rupture of membranes at <37 weeks of gestation were ran-domized into two antibiotic prophylactic protocols: ampicillin + roxithromy-cin and cefuroxime + roxithromycin. The latency period length, neonatal adverse outcomes, and maternal infectious morbidity, including intrauter-ine infection, intrapartum fever, postpartum antibiotic treatment, endome-tritis, and wound infection, were measured and compared.RESULTS: Maternal infectious morbidity was higher in the ampicillin group than in the cefuroxime group (17.7% vs 6.5%; 1-sided P value =.048). The pathogen distribution among placenta, membrane, cord, and uterine cultures differed between the groups (P=.017). Enterobacteriaceae spp. cultures were identified in 68.6% of the cultures in the ampicillin group and 43.2% in the cefuroxime group (P=.036). The composite neo-natal adverse outcome was higher in the ampicillin group than in the cefuroxime group (55 [88.7%] vs 46 [74.2%]; 1-sided P value =.03). The proportion of primiparas with a latency period >4 days was significantly higher in the cefuroxime group than in the ampicillin group (odds ratio, 3.69; 95% confidence interval, 1.175-11.607; P=.025).CONCLUSION: In combination with roxithromycin, the use of cefurox-ime, as a prophylactic in women with premature rupture of membranes at <37 weeks of gestation, showed longer pregnancy in primiparas and less maternal and neonatal morbidity than the use of ampicillin. Further larger studies are needed to support our results.

Automated summary

This study aimed to compare the efficacy of two antibiotic regimens in prolonging the latency period in women with premature rupture of membranes. The results showed that cefuroxime + roxithromycin combination prolonged pregnancy in primiparas and reduced the incidence of maternal and neonatal infections compared to ampicillin. Although there are some limitations, the study suggests that CEF + ROX could be a better treatment option.