Efficacy of Carbetocin at Elective Cesarean Section in Prevention of Postpartum Hemorrhage in Obese Versus Non-obese Women, A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Estimated Blood loss (ml) at cesarean section
研究概览
简要总结
Postpartum hemorrhage [PPH] can have serious consequences and is the leading cause of maternal mortality globally. Uterine contractility plays an important role in post-delivery uterine involution; impaired contractility can contribute to PPH. Should contractility be impaired among obese women, there would be implications for management. Therefore, the investigators sought to investigate whether obese women would also experience a need for more uterine agents during the management of an obstetric hemorrhage.
详细描述
The American College of Obstetricians and Gynecologists (ACOG) updated their definition of postpartum hemorrhage (PPH) to be "blood loss greater than or equal to 1000 ml or blood loss accompanied by signs or symptoms of hypovolemia" .
Recent clinical and translational studies have suggested a decrease in uterine contractility among obese and morbidly obese women as a primary cause of obstetric hemorrhage.
In the United States, the prevalence of maternal obesity has been steadily rising, with more than half of pregnant women classified as overweight or obese. A panel of obstetric experts has speculated that the rising prevalence of maternal obesity in developed countries may explain the increase in postpartum hemorrhage incidence.
Uterotonic drugs are recommended to reduce blood loss and the risk of postpartum hemorrhage (PPH) after Cesarean delivery.
There are several prophylactic uterotonic agents available for use, including oxytocin, oxytocin/ergometrine, and carbetocin. Carbetocin is a synthetic analog of oxytocin which provides a longer duration of action than oxytocin (half-life 85-100 min versus 3-4 min).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women with a singleton pregnancy undergoing a Cesarean delivery after at least 37 completed weeks of gestation under regional anesthesia.
- •Aged (18-39) years and with signed informed consent.
排除标准
- •Emergency Cesarean Section due to fetal distress.
- •Maternal comorbidities such as severe cardiovascular disorders, kidney or liver disorders, coagulopathies, as well as epilepsy.
- •Uterine malformation.
- •Fetal malformation.
- •Known hypersensitivity to carbetocin or oxytocin.
- •Uterine overdistention (as in polyhydramnios, twins, and fetal macrosomia)
- •Injury of uterine vessels during CS.
研究组 & 干预措施
Group A: Parturient with BMI ≥ 30 kg/m2.
All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. [PabalVR, Ferring AG, Baar, Switzerland]).
干预措施: Carbetocin 100 Microgram/mL Solution for Injection (Drug)
Group B: Parturients with BMI < 30kg/m2 (control group)
All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. [Pabal, Ferring , Baar, Switzerland]).
干预措施: Carbetocin 100 Microgram/mL Solution for Injection (Drug)
结局指标
主要结局
Estimated Blood loss (ml) at cesarean section
时间窗: 3 months
Estimation of blood loss will be by assessing difference between pre -operative hemoglobin and a 24 hours after delivery hemoglobin and pre and 24h after delivery hematocrit according to the following formula: Estimated blood volume (pre-operative Hct-postoperative Hct)/pre-operative Hct.
次要结局
- Uterine contractility and the need for more doses of carbetocin(3 months)
- Estimated Blood loss by weighing gauze towel(3 months)
研究者
Shaimaa Mostafa Mohammed Refaay El shemy
Lecturer at Obstetrics and Gynecology department
Cairo University