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临床试验/CTRI/2025/07/090836
CTRI/2025/07/090836招募中不适用

Minimum effective dose of carbetocin for preventing uterine atony during cesarean delivery:Comparison between patients with preterm versus term pregnancy.

University College of Medical Sciences and GTB Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
The ED90 dose (dose effective in 90% population) for satisfactory uterine tone as judged by the obstetrician

研究概览

简要总结

Aim: To evaluate and compare the optimal dose of carbetocin for preventing uterine atony during cesarean delivery in patients with preterm versus term pregnancy.

**Objective:**To evaluate and compare during cesarean delivery in patients with preterm and termpregnancy, the minimum effective dose (defined as ED90 i.e., dose expected to be adequate in 90% of target population) of carbetocin for achieving and maintaining adequate uterine tone.

The bolus dose of carbetocin will be injected over 30 seconds to 1 min immediately after delivery of fetal head. The dose will be 20 mic for the first patient in both cohorts. The dose in subsequent cases for either cohort will be determined by the response to the bolus in previous patient of the particular cohort. After a “failed” dose of carbetocin bolus, the subsequent patient of the group will receive amount greater by 10 mic. In case of a “successful” dose, it will be decreased by 10 mic with a probability of 1/9; otherwise it will remain unchanged. This method of biased-coin allocation method with a probability of 1/9 after a successful dose will be implemented by drawing chits out of an opaque bag. While 9/10 of the chits will read for “same dose” to be repeated, 1/10 will instruct for a “decrease in dose”. The instruction on the randomly pulled out chit will be followed. Determinant of a successful dose will be a satisfactory uterine tone at time of first assessment (2 min after carbetocin) along with no request of any additional uterotonic by obstetrician intraoperatively. Additional uterotonic will be given on request of obstetrician at any time after 2 minutes of carbetocin injection

Statistical analysis: The primary outcome i.e., the ED90 of carbetocin will be calculated using dose-response data for each group by applying log-logistic regression with bootstrapping.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Posted for cesarean delivery under spinal block, either into the term (completed 37 weeks) or preterm (less than 37 weeks) cohort.

排除标准

  • Patients in labor, receiving preoperative oxytocin or megnesium sulfate therapy,with coagulopathy, history of previous uterine atony or postpartum hemorrhage or bleeding disorder or heart disease will be excluded.

结局指标

主要结局

The ED90 dose (dose effective in 90% population) for satisfactory uterine tone as judged by the obstetrician

时间窗: From 2 minutes after carbetocin to end of surgery.

次要结局

  • Carbetocin associated side effects like hypotension, tachycardia(From administration of carbetocin to 10 minutes later.)

研究者

发起方
University College of Medical Sciences and GTB Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Asha Tyagi

University College of Medical Sciences and GTB Hospital

研究点 (1)

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