Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Uterine tone 2 minutes: questionnaire
研究概览
简要总结
Poor uterine tone after the birth of a baby can cause excess bleeding (called postpartum hemorrhage or PPH). This is a major cause of maternal death worldwide. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In a study performed at Mount Sinai Hospital, the investigators have shown that smaller doses of carbetocin (14.8 mcg) are effective in achieving adequate uterine tone at elective cesarean section.
In these dose-finding studies, women with multiple pregnancies have been excluded. Because women with multiple pregnancy have a higher risk of severe PPH, uterine atony, hysterectomy, prolonged hospital stay and death, it is plausible that a higher dose of carbetocin is required. This question remains unanswered.
The hypothesis is that the ED90 of carbetocin in women with twin pregnancy undergoing elective cesarean delivery under regional anesthesia is greater than 20 mcg but less than 100 mcg.
详细描述
There is a lack of consensus as to what the optimal uterotonic regime is globally. Furthermore, variability in the international guidelines regarding the choice of first line uterotonic in prevention of PPH adds to the confusion. With the widespread availability of carbetocin in some developed countries, including Canada, the question of which uterotonic to adopt and at which dose becomes even more difficult to ascertain. Studies that have currently been published suggest the ED90 doses of carbetocin and oxytocin provide adequate uterine contraction with possibly fewer side effects associated with the lower dose regimens. There is evidence to suggest that lower doses of both carbetocin provide equivalent uterine contractions with a better side effect profile in patients with a singleton pregnancy. However, there is no clinical dosing data specifically for patients with twin pregnancy. The results of our study will provide guidance to obstetric and anesthetic providers worldwide when deciding what dose of carbetocin to use in women with twin pregnancy.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Twin Pregnancy
- •Elective cesarean delivery under regional anesthesia
- •Gestational age ≥ 36 weeks
- •No known additional risk factors for postpartum hemorrhage
- •Written informed consent to participate in this study
排除标准
- •Refusal to give written informed consent
- •Allergy or hypersensitivity to oxytocin
- •Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI >40
- •Hepatic, renal, and vascular disease
- •Use of general anesthesia prior to the administration of the study drug
研究组 & 干预措施
Carbetocin 10mcg
Patient is given 10mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.
干预措施: Carbetocin (Drug)
Carbetocin 20mcg
Patient is given 20mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.
干预措施: Carbetocin (Drug)
Carbetocin 40mcg
Patient is given 40mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.
干预措施: Carbetocin (Drug)
Carbetocin 60mcg
Patient is given 60mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.
干预措施: Carbetocin (Drug)
Carbetocin 80mcg
Patient is given 80mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.
干预措施: Carbetocin (Drug)
Carbetocin 100mcg
Patient is given 100mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.
干预措施: Carbetocin (Drug)
结局指标
主要结局
Uterine tone 2 minutes: questionnaire
时间窗: 2 minutes
Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the carbetocin injection.
次要结局
- Presence of ventricular tachycardia: ECG(2 hours)
- Presence of atrial flutter: ECG(2 hours)
- Presence of vomiting: questionnaire(2 hours)
- Estimated blood loss(24 hours)
- Presence of shortness of breath: questionnaire(2 hours)
- Additional uterotonics administered(1 hour)
- Intravenous fluid administered during surgery(2 hours)
- Presence of atrial fibrillation: ECG(2 hours)
- Presence of nausea: questionnaire(2 hours)
- Presence of chest pain: questionnaire(2 hours)
- Uterine tone 5 minutes: questionnaire(5 minutes)
- Tachycardia: heart rate greater than 130% of baseline(2 hours)
- Bradycardia: heart rate less than 70% of baseline(2 hours)
- Hypotension: systolic blood pressure less than 80% of baseline(2 hours)
- Presence of headache: questionnaire(2 hours)
- Presence of flushing: questionnaire(2 hours)