ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery
ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery
研究概览
详细说明
Postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide. Carbetocin have been shown effective in the prevention of uterine atony, which is the leading cause of postpartum hemorrhage. The Society of Obstetricians and Gynecologists of Canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to prevent postpartum hemorrhage. However, there is no clear data in the literature regarding the lowest effective dose of carbetocin that should be administered. The use of the minimum effective dose of carbetocin may reduce its side effects, including hypotension, tachycardia, nausea, vomiting and flushing.
In this trial, healthy term pregnant women undergoing elective cesarean delivery under spinal anesthesia will be recruited. The effective dose of carbetocin that will prevent postpartum uterine atony in 90% of the women (ED90) will be determined using a biased coin design up-down sequential allocation method. The determination of the carbetocin ED90 will help the anesthesiologist regarding the optimal dose of carbetocin to administer after elective cesarean delivery to prevent uterine atony.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Quebec
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Montreal、Quebec、加拿大、H1T 2M4
- 招聘中
- Maisonneuve-Rosemont Hospital
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接触：
- Christian Loubert, MD, FRCPC
- 电话号码：514.252.3426
- 邮箱：loubertch@yahoo.fr
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接触：
- Louis-Philippe Fortier, MD, FRCPC
- 电话号码：514.252.3426
- 邮箱：lpfortier@mac.com
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首席研究员：
- Christian Loubert, MD, FRCPC
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副研究员：
- Louis-Philippe Fortier, MD, FRCPC
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副研究员：
- Patrick Coursol-Provost, MD
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副研究员：
- Pierre Drolet, MD, FRCPC
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy pregnant women (ASA I or II)
- Elective cesarean delivery
- Spinal anesthesia
- Term gestation (37 weeks and above)
Exclusion Criteria:
- Multiple gestation
- Known coagulopathy
- Active labour
- Uterine fibroids
- Body mass index > 45
- Emergency cesarean section
- General anesthesia
- Any contraindication to neuraxial anesthesia
- Cardiopathies
- Known allergies to carbetocin
- Patient refusal
- Placenta previa/Placenta accreta
- Hypertensive disease/Preeclampsia/Eclampsia
- Polyhydramnios
- Previous history of uterine atony or postpartum hemorrhage
- Renal or liver disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Carbetocin
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First patient: 70 mcg.
Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg.
An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dose of carbetocin which will prevent uterine atony in 90% of subjects
大体时间：5 minutes
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The uterine tone will be assessed by the obstetrician by palpation 5 minutes after injection.
The uterine tone will be judged either as satisfactory or unsatisfactory.
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5 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of side effects
大体时间：20 minutes
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Any of these side effects will be noted in the first 20 minutes following injection of carbetocin: hypotension, tachycardia, nausea, vomiting, flushing, headache, feeling of warmth, tremor, metallic taste, abdominal pain, back pain, chest pain and others.
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20 minutes
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Vasopressors administered
大体时间：20 minutes
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The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted.
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20 minutes
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Anti nausea therapy
大体时间：20 minutes
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20 minutes
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Additional uterotonic medication administered
大体时间：20 minutes
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20 minutes
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Additional uterine massage
大体时间：20 minutes
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20 minutes
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合作者和调查者
调查人员
- 首席研究员：Christian Loubert, MD, FRCPC、Maisonneuve-Rosemont Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
产后出血的临床试验
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