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临床试验/NCT04726085
NCT04726085终止不适用

Efficacy of Ibuprofen Versus Indomethacin as Perioperative Prophylactic Treatment Following Emergent Cerclage Placement for Pregnancy Prolongation: A Randomized Controlled Trial

Woman's1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement

干预措施: Ibuprofen 2400mg (Drug)

Indomethacin

Active Comparator

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)

研究者

发起方
Woman's
申办方类型
Other
责任方
Sponsor

研究点 (1)

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