Tranexamic Acid and Ethamsylate For Preventing Post Partum Hemorrhage in Patient Undergoing LSCS at High Risk For Post PartumHemorrhage : A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 64
- 主要终点
- PPH defined as blood loss ≥500 cc
研究概览
简要总结
The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage
详细描述
Research Question:
Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing elective caesarean section
- •Patient having one or more risk factor for PPH
- •Multiple pregnancy
- •Polyhydramnios (AFI >25cm)
- •Macrocosmic baby (>4.5 Kg)
- •Prolonged , augmented and obstructed labour
- •Obese patients(BMI >30)
- •Premature rapture of membranes
- •Previous history of PPH
- •Age ≥18 years
- •Gestational Age ≥ 35 Weeks
- •Informed Oral Consent From The Patient
排除标准
- •History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke)
- •History of epilepsy or seizure
- •Any Known Cardiovascular , renal or liver Disease
- •Autoimmune Diseases
- •Sickle Cell Disease
- •Severe hemorrhagic Disease
- •Placenta Previa.
- •Morbidly adherent Placenta
- •Abruptio placenta
- •Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome
- •Administration Of low molecular weight heparin or Anti platelets the week before delivery .
研究组 & 干预措施
tanexamic acid and Ethamsylate
10 ml of the study drugs (1 gm Tranexamic acid and 1 gm Ethamsylate ) slowly (over 30-60 sec ) in the 2 minutes after birth
干预措施: Tranexamic Acid and Ethamsylate (Drug)
placebo
10 ml normal saline will be administered intravenously just after birth
干预措施: Tranexamic Acid and Ethamsylate (Drug)
结局指标
主要结局
PPH defined as blood loss ≥500 cc
时间窗: the first 24hours
measured by pads placed under women buttocks
次要结局
- severe PPH (>1000 cc), .(first 24 hours)
研究者
Ahmed Alanwar
dr.ahmed alanwar
Ain Shams University