Carbetocin in the Prevention of Primary Postpartum Haemorrhage in Obese Versus Non-obese Women Undergoing Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Post postpartum bleeding
研究概览
简要总结
Postpartum haemorrhage (PPH) ranks as the first cause of maternal mortality in developing countries and it is the cause of 25% of maternal deaths worldwide.
Carbetocin is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions and increased uterine tone.
详细描述
Postpartum hemorrhage is defined as a blood loss more than 500 ml, and serious PPH as a blood loss more than 1,000 ml.
It is a common maternal morbidity in high-resource countries and is trending upward and prevention of postpartum haemorrhage is, therefore, of great importance for improved maternal health care.
Although two-thirds of the PPH cases occur in women without predisposing factors, there are several risk factors for PPH. The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases .
Studies investigating effect of increased BMI on birth outcomes in a general obstetric population revealed an association between obesity and PPH. The overall increased risk of postpartum hemorrhage among obese women was 8-13%, depending on obesity class.
The risk of postpartum haemorrhage is much higher for women undergoing Cesarean section, particularly in developing countries, where the majority of operations are carried out as an emergency procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 20-40years.
- •Body mass index (BMI): Obese ≥30 kg/m2 and non-obese women <30 kg/m2 calculated using maternal height and weight measured to the nearest centimeter and kilogram, respectively, at time of admission to labor word.
- •Gestational age: Gestational age ≥37 weeks (gestational age will be recorded according to the last menstrual period and confirmed by ultrasound). In case of discrepancy, a 1st trimesteric ultrasound will be taken as the actual gestational age.
- •Singleton pregnancy.
排除标准
- •Patients who have any factors that might increase the risk of postpartum haemorrhage will be excluded as anemic patients (Hb<10.5g%), antepartum haemorrhage ( placenta previa, placental abruption ), uterine myomata, multiple gestation, polyhydramnios.
- •Patients with pre-existing bleeding or thromboembolic disorder.
- •Patients with chronic medical diseases (cardiac, hepatic, renal)
研究组 & 干预措施
Group A: Obese Pregnant Females
About 122 Pregnant women candidate for elective cesarean section suffering from obesity where as Body mass index (BMI) is ≥30 kg/m2
干预措施: Carbetocin (Drug)
Group B: Non-Obese Pregnant Females
About 122 Pregnant women candidate for elective cesarean section and not obese obesity where as Body mass index (BMI) is < 30 kg/m2
干预措施: Carbetocin (Drug)
结局指标
主要结局
Post postpartum bleeding
时间窗: first 6 hours after the Cesarean Section
To compare the incidence of primary postpartum hemorrhage in both groups receiving carbetocin
次要结局
- Sever PPH as bleeding is >1000 cc(first 24 hours after Cesarean Section)
研究者
Dina Sanad Tawfik Allam
Specialist of Obstetrics and Gynecology at AlSahelTeaching Hospital
Ministry of Health and Population, Egypt