Role in Emergent Cerclage of Indomethacin and Antibiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
研究概览
简要总结
Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.
The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •GA 16+0 to 23+6 weeks
- •Singleton gestation
- •Presence of cervical dilation as diagnosed on digital examination
- •Intact membranes
排除标准
- •Age <18 years
- •Allergy to NSAIDs
- •Renal disease
- •Allergy to penicillins AND clindamycin
- •Currently on antibiotics or indomethacin for any reason
- •HIV positive
- •Pregnancies complicated by fetal congenital anomalies
- •Preterm premature rupture of membranes
- •Fever of 100.4 degrees Fahrenheit or higher
- •Any patient having received a therapeutic cerclage during the current pregnancy
研究组 & 干预措施
indomethacin and antibiotics
perioperative antibiotics and indomethacin
干预措施: Indomethacin and antibiotics (cefazolin or clindamycin) (Drug)
结局指标
主要结局
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
时间窗: 24 weeks
Median gestational latency achieved Between Cerclage Placement and Time of Delivery
次要结局
- Neonatal Morbidity and Mortality(1 year)
- Gestational Latency of More Than 28 Days(28 days postpartum)
- Gestational Age at Delivery(24 weeks)
- Birthweight(24 weeks)
研究者
William Grobman
principal investigator
Northwestern University