Carbetocin at Elective Cesarean Delivery: A Dose Finding Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Uterine tone.
研究概览
简要总结
Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published.
We hypothesize that a dose-response study will establish the minimum dose of carbetocin required to produce appropriate contractility in 95% of the women (ED95) undergoing elective cesarean delivery.
详细描述
The Society of Obstetricians and Gynecologists of Canada (SOGC)recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery. However, a dose response study to determine the minimum effective dose of carbetocin has not yet been published.
Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effects profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin.
The results of this study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients planned for elective cesarean delivery under spinal anesthesia;
- •All patients who gave written informed consent to participate in this study.
排除标准
- •All patients who refuse to give written informed consent.
- •All patients who claim allergy or hypersensitivity to carbetocin or oxytocin.
- •All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
- •All patients with hepatic, renal, and vascular disease,
- •All patients requiring general anesthesia prior to the administration of the study drug.
研究组 & 干预措施
Carbetocin 80mcg
干预措施: Carbetocin (Drug)
Carbetocin 90mcg
干预措施: Carbetocin (Drug)
Carbetocin 100mcg
干预措施: Carbetocin (Drug)
Carbetocin 110mcg
干预措施: Carbetocin (Drug)
Carbetocin 120mcg
干预措施: Carbetocin (Drug)
结局指标
主要结局
Uterine tone.
时间窗: 2 minutes
The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).
次要结局
- Uterine tone(2 hours)
- Blood loss(48 hours)
- Side effects(2 hours)