Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery: a Double-blind Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Uterine Tone 10 minutes
研究概览
简要总结
Postpartum hemorrhage (PPH) is a leading cause of maternal mortality, and its severity has been increasing globally, including in high-income countries. The most common cause of PPH is uterine atony occurring in about 70% of cases. Uterotonic agents, like oxytocin, are key in managing the third stage of labour to prevent PPH. Oxytocin is a short-acting medication and requires frequent dosing, however, carbetocin, a longer-acting analogue that can be administered as a single dose, provides sustained uterotonic activity. Calcium chloride is a readily available, inexpensive medication that has been studied as an adjunct to primary uterotonics due to its role in uterine contractility. A randomized trial found no overall reduction in blood loss with calcium chloride and oxytocin, but a subgroup analysis suggested it may reduce bleeding in cases of uterine atony. This study was conducted in the US where carbetocin is not readily available. The investigators propose a double-blind randomized trial investigating if co-administering calcium chloride with carbetocin during scheduled cesarean deliveries reduces PPH secondary to uterine atony.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Scheduled CD for patients ≥ 37 weeks excluding high risk factors for uterine atony
- •Neuraxial anesthesia as the primary anesthetic where intrathecal medications are the primary anesthetic
排除标准
- •Risk factors for uterine atony including:
- •Overdistended uterus due to fetal macrosomia reported on prenatal ultrasound >90th centile or > 4000 gm, multiple gestation, grand multiparity (≥5 births at ≥ 20 weeks gestation), polyhydramnios
- •History of uterine atony/PPH (documented with blood loss > 2000 ml, blood transfusion, use of surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)
- •Obesity with body mass index (BMI) > 40 kg/m2
- •Placenta previa and/or placenta accreta
- •Digoxin therapy within 14 days (hypercalcemia can exacerbate digoxin toxicity)
- •Patients needing intraoperative IV ceftriaxone or tetracycline.
- •Kidney disease including Stage 3 chronic kidney disease, serum creatinine above 120 mmol/L or GFR <60 ml/min (to prevent hypercalcemia due to reduced creatinine clearance in those with impaired kidney function as calcium is renally excreted)
- •Calcium channel blockade within 24 hours (opposing effect)
- •Known history of cardiac disease including arrhythmias, ischemia, and congenital heart disease (to avoid attributing cardiac symptoms to study drugs)
- •Preexisting hypertension, preeclampsia or persistent elevated blood pressure above 160/100 mmHg requiring treatment
- •Emergency cesarean deliveries or women in labor
- •Planned general anesthetic for patients where neuraxial is contraindicated.
研究组 & 干预措施
Placebo
Intravenous administration of 100ml normal saline, over 10 minutes.
干预措施: Placebo (Other)
Placebo
Intravenous administration of 100ml normal saline, over 10 minutes.
干预措施: Carbetocin (Drug)
Calcium
Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.
干预措施: Calcium Chloride (Drug)
Calcium
Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.
干预措施: Carbetocin (Drug)
结局指标
主要结局
Uterine Tone 10 minutes
时间窗: 10 minutes
The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 10 minutes post-fetal delivery, utilizing a verbal numeric rating scale of 0-10.
次要结局
- Uterine Tone baseline(1 minute)
- Uterine Tone 5 minutes(5 minutes)
- Uterine Tone 20 minutes(20 minutes)
- Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours(24 hours)
- Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline(2 hours)
- Number of patients with tachycardia defined as heart rate greater than 130% of baseline(2 hours)
- Presence of atrial fibrillation: ECG(2 hours)
- Uterine Tone 15 minutes(15 minutes)
- Number of patients with conservative surgical methods to manage post partum hemorrhage(2 hours)
- Number of patients with radiological methods used to manage post partum hemorrhage(2 hours)
- Presence of nausea: questionnaire(2 hours)
- Additional uterotonic agents required intraoperatively(90 minutes)
- Additional uterotonic agents required post-operatively(24 hours)
- Semi-quantitative blood loss (SQBL)(90 minutes)
- Incidence of postpartum hemorrhage(24 hours)
- Presence of blood transfusion(24 hours)
- Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline(2 hours)
- Number of patients with bradycardia defined as heart rate less than 70% of baseline(2 hours)
- Presence of atrial flutter: ECG(2 hours)
- Presence of vomiting: questionnaire(2 hours)
- Number of patients with chest pain: questionnaire(2 hours)
- Number of patients with irritation at the intravenous site: questionnaire(2 hours)