ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dose of carbetocin which will prevent uterine atony in 90% of subjects
研究概览
简要总结
The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnant women (ASA I or II)
- •Elective cesarean delivery
- •Spinal anesthesia
- •Term gestation (37 weeks and above)
排除标准
- •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
研究组 & 干预措施
Carbetocin
干预措施: Carbetocin (Drug)
结局指标
主要结局
Dose of carbetocin which will prevent uterine atony in 90% of subjects
时间窗: 5 minutes
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.
次要结局
- Incidence of side effects(20 minutes)
- Vasopressors administered(20 minutes)
- Anti nausea therapy(20 minutes)
- Additional uterotonic medication administered(20 minutes)
- Additional uterine massage(20 minutes)
研究者
Christian Loubert
Christian Loubert, MD, FRCPC
Maisonneuve-Rosemont Hospital