Prophylactic Regimen of Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative for Primary Prevention of Postpartum Hemorrhage in Intrapartum Cesarean Section Versus Intravenous Carbetocin Alone
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Amount of blood loss
研究概览
简要总结
While Carbetocin is effective in reducing PPH, the combination of oxytocin, Tranexamic acid, and Ergot derivatives may offer additional benefits in high-risk populations. We hypothesize that the combination regimen will reduce PPH incidence and severity compared to Carbetocin alone and may be more cost effective
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
- Double (Participant, Investigator)
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
- •Women undergoing C-Sections.
- •Women between the ages of 18 and 45 years.
- •Singleton pregnancy.
- •Gestational age is equal to or more than 36 weeks.
- •No known coagulopathy or bleeding disorders.
- •No known hypersensitivity or allergy to drugs used in the study.
- •Normal obstetric ultrasonography with no fetal abnormalities.
排除标准
- •Hemodynamically unstable or immobile patients.
- •Multifetal pregnancy.
- •Patients who are receiving prophylactic or therapeutic anticoagulation.
- •Known comorbidities and contraindications to the use of Ergot derivatives or Carbetocin such as hypertension or cardiovascular disorders.
- •Placenta previa and/or Placenta accreta spectrum.
- •History of thromboembolism.
- •Preeclampsia or eclampsia.
- •Any additional measurements needed to control or stop excessive bleeding intraoperatively such as uterine artery ligation or use of sterile gelatin absorbable foam.
研究组 & 干预措施
Group A
Group A will receive a combination regimen of intravenous Oxytocin (5-10IU), Tranexamic acid (intravenous bolus 1 gram), and intramuscular ergot derivative (methylergometrine maleate 0.2 mg/ ml).
The participants will receive intravenous Oxytocin immediately after delivery of the fetus, intravenous Tranexamic acid during the procedure and intramuscular Ergot derivative after delivery of the placenta
干预措施: Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative (Drug)
Group B
Group B will receive intravenous Carbetocin (100 mcg) only. The participants will receive intravenous Carbetocin only immediately after delivery of the fetus.
干预措施: Intravenous Carbetocin alone (Drug)
结局指标
主要结局
Amount of blood loss
时间窗: during and up to 24 hours after cesarean section
次要结局
未报告次要终点
研究者
Abdalla Mousa
Lecturer of Obstetrics and Gynecology
Cairo University