The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section
研究概览
简要总结
The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section
详细描述
The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section.
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
- 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
- 否
入选标准
- •Age 18 years or more.
- •Gestational age of pregnancy of 37 completed weeks or more.
- •Written and signed informed consent by the patient to participate in the study.
排除标准
- •fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize.
- •Women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only.
- •Women planned to have any other type of uterine incision other than transverse lower segment.
- •Women with HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), eclampsia, and epilepsy .
- •Women with placental abruption are excluded because there is a higher risk of hemorrhage with this condition and it was therefore felt to be inappropriate to recruit these women.
- •Women with thrombocytopenia, known coagulopathies, or receiving anticoagulant therapy.
- •Women with history of significant heart disease, a history or evidence of liver, renal, vascular disease or endocrine disease (other than gestational diabetes).
- •Women with history of hypersensitivity to oxytocin or carbetocin.
- •Women with any severe allergic condition or severe asthma.
- •Women with any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs) or glaucoma.
- •Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
研究组 & 干预措施
Syntocinon
Drug is given just after delivery of the neonate during cesarean section.
干预措施: Syntocinon (Drug)
Carbetocin
Drug is given just after delivery of the neonate during cesarean section.
干预措施: Carbetocin (Drug)
Misoprostol
Drug is given just after delivery of the neonate during cesarean section.
干预措施: Misoprostol (Drug)
结局指标
主要结局
To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section
时间窗: an expected average 1 week
次要结局
- Adverse events recorded during the study.(an expected average 1 week)
研究者
karim H abdel-maeboud
Professor
Ain Shams University