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 rupture 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 antibiotic regimens in prolonging the latency period in women with preterm premature 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 randomized into two antibiotic prophylactic protocols: ampicillin + roxithromycin and cefuroxime + roxithromycin. The latency period length, neonatal adverse outcomes, and maternal infectious morbidity, including intrauterine infection, intrapartum fever, postpartum antibiotic treatment, endometritis, 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 neonatal 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 cefuroxime, 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.