Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)
研究概览
简要总结
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate, Pre-operative Administration.
详细描述
Caesarean Delivery commonly referred to as caesarean section and occasionally caesarean birth is defined as the delivery of a foetus(es) through surgical incisions made through the anterior abdominal wall (technically referred to as laparotomy) and the anterior uterine wall (technically denoted to as hysterotomy).
Obstetric Hemorrhage (Intra operative OR post operative bleeding)is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. And accounts for 50% of maternal mortality in low-income countries.
So many Strategies reducing the intraoperative blood loss or post operative blood loss could be helpful in decreasing the risks of blood transfusion and the postoperative maternal morbidity.
So these Medications are such as Oxytocin, Carbetocin, Misoprostol, Prostaglandin F2 alpha, methylergonovine, Tranexamic acid and Etamsylate . have been tried before to control bleeding during and after Cesarean Section.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant females admitted for elective Cesarean Section.
- •Gestational age (38 to 41 weeks).
- •Age of the participants: 20 to 40 years.
- •Body Mass Index (18.5 - 29.9).
- •Singleton living fetus.
- •No medical disorders.
- •Informed written consent from the candidates.
- •Exclusion criteria:
- •Medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid-stimulating hormone(TSH), all of them should be within normal limits).
- •Bleeding tendency, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
- •Acute and chronic liver or kidney diseases; blood disorders, such as anemia.
- •Allergy to Tranexamic acid or any drug used.
- •Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage.
- •Abnormal placentae such as placenta previa and placental abruption.
- •Pregnancy complications such as severe pre-eclampsia, Gestational HTN, Gestational DM, and multi Fetal pregnancies, those requiring blood transfusion.
- •Patients who refused spinal anesthesia.
排除标准
- 未提供
研究组 & 干预措施
Oxytocin(only)
oxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section
干预措施: Oxytocin ,Tranexamic acid and Ethamsylate (Drug)
Tranexamic acid and Ethamsylate
Tranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section
干预措施: Oxytocin ,Tranexamic acid and Ethamsylate (Drug)
结局指标
主要结局
Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)
时间窗: First 2 hours after C-Section
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.
次要结局
- Sever PPH as bleeding is >1000 cc(first 24 hours after C-Section)
研究者
DR.ABDELAZIM
Assistant specialist
Egymedicalpedia