Efficacy of Ibuprofen Versus Indomethacin as Perioperative Prophylactic Treatment Following Emergent Cerclage Placement for Pregnancy Prolongation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Gestational latency
研究概览
简要总结
Cervical insufficiency is defined as painless cervical dilation in the second trimester. Cervical insufficiency can ultimately lead to second trimester loss of pregnancy. Cerclages are utilized in pregnancies affected by cervical insufficiency in order to prolong gestational latency. There have been several studies investigating the efficacy of perioperative medications for cerclage placement and the effects they have on gestational latency. Some such studies have found that perioperative indomethacin in combination with antibiotics have significantly increased gestational latency when compared to placebo. Indomethacin has traditionally been the tocolytic of choice with cerclage placement. At our hospital, ibuprofen has been the tocolytic of choice for cerclage placement secondary to pharmacy availability. Our study aims to evaluate whether gestational latency differs among patients undergoing emergent cerclage whether they receive perioperative ibuprofen or indomethacin.
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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Viable, singleton pregnancy
- •≥ 18 years old
- •Gestational age 16 weeks 0/7 days - 23 week 6/7 days (inclusive)
- •Intact membranes at time of enrollment
- •Planning to deliver at Woman's Hospital
- •Exam or ultrasound indicated cerclage placement
排除标准
- •Contraindication to treatments (i.e. ibuprofen or indomethacin)
- •Unwilling to be randomized to treatment
- •Prophylactic cerclage placement
- •Temperature greater than 100.4
- •Known major fetal congenital anomaly
- •Prior cerclage placement during the current pregnancy
- •Recent (within 7 days) receipt of ibuprofen or indomethacin
研究组 & 干预措施
Ibuprofen
Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement
干预措施: Ibuprofen 2400mg (Drug)
Indomethacin
Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement
干预措施: Indomethacin 150mg (Drug)
结局指标
主要结局
Gestational latency
时间窗: From cerclage placement to delivery
Days from cerclage placement to delivery, assessed up to 26 weeks
次要结局
- Preterm birth(At delivery)
