A Comparison Between Carbetocin, Oxytocin and Ergometrine in Prevention of Postpartum Haemorrhage Following Caesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Uterine tone and size
研究概览
简要总结
The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin & ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.
详细描述
- Postpartum hemorrhage (PPH) accounts for nearly one quarter of all maternal deaths worldwide 1 and was the second most frequent cause of maternal death in the UK for the 2000-2002 triennium.
- Caesarean section is a recognized risk factor for PPH and the worldwide caesarean delivery rate is increasing .2
- A combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension.
- A recent guideline on PPH prevention developed by the World Health Organization recommended the use of oxytocin for prevention of PPH in settings in which active management of labor is not practiced.
- Ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia.
- Carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. It is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects .
- A prospective double blinded randomized study . The study population will include 200 patients. The study will take place in Beni_suef University Hospitals.
- Inclusion criteria:
• Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation.
-
Exclusion criteria
-
Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
-
women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
-
Hypertension with pregnancy.
-
Cardiac and coronary diseases with pregnancy
-
Women included in the study were divided into 2 groups:
.Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of the fetal head.
.Group (B): including 100 patients who will receive a combination of intraoperative oxytocin 5 I.U & ergometrine 0.2 mg.
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
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.
排除标准
- •Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
- •women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
- •Hypertension with pregnancy.
- •Cardiac and coronary diseases with pregnancy
研究组 & 干预措施
Pabal ( carbetocin)
Pabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head.
干预措施: Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head (Drug)
Oxytocin and Methergine (methyl ergometrine)
The second group of patients included in the study will be given Oxytocin 5 IU ampoule by intravenous infusion and Methergine 0.2 mg IV after delivery of fetal head.
干预措施: Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv (Drug)
结局指标
主要结局
Uterine tone and size
时间窗: One hour after the cesarean section
The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.
次要结局
- Blood loss(One hour after cesarean section)
研究者
Nesreen Abdel Fattah Abdullah Shehata
Lecturer of Obstetrics and Gynecology
Beni-Suef University