Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Utilization of a second uterotonic drug
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.
详细描述
Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.
Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •≥ 37-week pregnancy
- •singleton pregnancy
- •elective cesarean section with a low transverse incision
- •ASA I or II
排除标准
- •Personal history of uterine atony or postpartum hemorrhage
- •Abnormal placental implantation (known or suspected)
- •> 3 cesarean sections in the past
- •Personal history of a classic uterine incision
- •Estimated fetal weight > 4500g
- •Hemoglobin < 100 g/L
- •Regular use of tocolytic drugs
- •Cesarean section under general anesthesia
- •Known allergy to carbetocin
- •Inability to obtain informed consent
研究组 & 干预措施
Carbetocin 100 mcg
干预措施: Carbetocin (Drug)
Carbetocin 50 mcg
干预措施: Carbetocin (Drug)
结局指标
主要结局
Utilization of a second uterotonic drug
时间窗: First 48 hours of the postpartum
次要结局
- Incidence of side effects(During the fifteen minutes following the administration of carbetocin)
- Incidence of major complications(First 48 hours of the postpartum)
- Drop in hemoglobin measurement(on the second post-partum day)