Sgayer Inshirah, Francis Yara Nakhleh, Miron Dan, Shprits Elizabeta, Sheffer Vered Fleisher, Rechnitzer Hagai, Lowenstein Lior, Wolf Maya Frank
Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar-Ilan University, Ramat Gan, Israel.
Department of Pediatrics, Emek Medical Center, Afula, Israel; Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.
Am J Obstet Gynecol MFM. 2023 May;5(5):100900. doi: 10.1016/j.ajogmf.2023.100900. Epub 2023 Feb 13.
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.
This study aimed to determine the efficacy of two antibiotic regimens in prolonging the latency period in women with preterm premature rupture of membranes.
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.
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).
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.
胎膜早破的预防性抗生素使用与羊膜腔内感染显著减少及新生儿结局改善相关，尽管数据不足以确定最佳抗生素方案。氨苄西林耐药已改变新生儿败血症的流行病学。
本研究旨在确定两种抗生素方案对延长胎膜早破孕妇潜伏期的疗效。
本随机对照试验在3家大学附属医院进行。共有124例妊娠<37周的胎膜早破孕妇被随机分为两种抗生素预防方案：氨苄西林+罗红霉素和头孢呋辛+罗红霉素。测量并比较潜伏期长度、新生儿不良结局及母体感染性疾病，包括宫内感染、产时发热、产后抗生素治疗、子宫内膜炎和伤口感染。
氨苄西林组的母体感染性疾病发生率高于头孢呋辛组（17.7%对6.5%；单侧P值=0.048）。两组胎盘、胎膜、脐带和子宫培养物中的病原体分布不同（P=0.017）。氨苄西林组68.6%的培养物中鉴定出肠杆菌科细菌，头孢呋辛组为43.2%（P=0.036）。氨苄西林组的复合新生儿不良结局高于头孢呋辛组（55例[88.7%]对46例[74.2%]；单侧P值=0.03）。头孢呋辛组潜伏期>4天的初产妇比例显著高于氨苄西林组（优势比，3.69；95%置信区间，1.175 - 11.607；P=0.025）。
与罗红霉素联合使用时，在妊娠<37周的胎膜早破孕妇中，头孢呋辛作为预防性用药，与氨苄西林相比，初产妇的孕期更长，母体和新生儿发病率更低。需要进一步的大型研究来支持我们的结果。
