Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- endometritis rate
研究概览
简要总结
This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity
详细描述
Maternal peripartum fever is a common complication of pregnancy and postpartum period associated with potentially serious obstetrical outcomes and infectious morbidity. Peripartum infections includes intrapartum intraamniotic infection (IAI) and postpartum endometritis. Both are caused by polymicrobial bacterial infection. Increased latency period from rupture of membranes (ROM) until delivery is a common risk factor. Another risk factor is pre-term delivery.
This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity.
Primary outcome-peripartum infections- chorioamnionitis, endometritis and surgical site infection secondary outcome- obstetrical outcome- mode of delivery, Apgar score, cord blood pH, peripartum fever, maternal length of admission, postpartum maternal antibiotic treatment, Surface swab cultures were obtained from the placenta, amnion and umbilical cord (birth cultures) and uterine swab cultures, maternal blood culture, placental histologic evaluation neonatal outcomes-NICU admission, length of admission, neonatal morbidity-ventilation support, early neonatal sepsis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery
排除标准
- •GBS carrier
- •preterm premature rupture of membrane for conservative treatment
- •intra-uterine fetal death fetal major anomaly
- •drug allergy for the antibiotic in use in this study
- •women receiving antibiotic treatment for other infection such as urinary tract infection
研究组 & 干预措施
women with term prolonged>18h rupture of membrane
women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery
干预措施: Ampicillin Only Product (Drug)
women with term prolonged>18h rupture of membrane
women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery
干预措施: ampicillin plus gentamicin (Drug)
women with preterm labor
women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery plus IV gentamicin 5 mg/kg every 24 hours
干预措施: Ampicillin Only Product (Drug)
women with preterm labor
women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery plus IV gentamicin 5 mg/kg every 24 hours
干预措施: ampicillin plus gentamicin (Drug)
结局指标
主要结局
endometritis rate
时间窗: up to 6 weeks postpartum
chorioamnionitis rate
时间窗: during labor (up to delivery of the newborn)
次要结局
- cord blood pH(immediately after delivery of the placenta)
- maternal intrapartum fever(during labor (up to delivery of the newborn))
- NICU (neonatal intensive care unit) hospitalization length,(up to 3 month from delivery)
- rate of neonatal early onset sepsis(up to one week from delivery)
- Rate of participants treated with antibiotics during the postpartum period(6 week postpartum)
- maternal postpartum hospitalization length(up to 6 weeks post partum)
- Number of neonate with ventilation support(one week from delivery)
- Number of neonate treated with antibiotics(one week from delivery)
研究者
Dr. Maya Wolf
Director- Fetal Maternal Medicine Unit
Western Galilee Hospital-Nahariya