Tranexamic Acid for the Prevention of Blood Loss After Vaginal Delivery in a High Risk Pregnancy: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery)
研究概览
简要总结
Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage
详细描述
Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding.
A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
All providers and delivered women will be blinded for the content of the bags which will be applied for women randomly
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 year.
- •Planed vaginal delivery
- •Grand multiparity
- •Twin pregnancy
- •Polyhydramnios
- •Previous history of PPH
- •Macrosomic baby
- •Prolonged labour
- •HELLP syndrome
- •Using of low-molecular weight heparin and Asprin during pregnancy.
- •Vaginal birth after Cesarean section
排除标准
- •Intrauterine death.
- •History of thromboembolic disease
- •Current or previous history of heart disease ,renal and liver disorders
- •History of seizure or epilepsy
- •Placenta previa
- •Placental abruptio
研究组 & 干预措施
Tranexamic group
Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water
干预措施: Tranexamic acid injection (Drug)
Tranexamic group
Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water
干预措施: Glucose water 5% (Other)
Placebo group
Group B will receive 30ML 5% glucose water
干预措施: Tranexamic acid injection (Drug)
Placebo group
Group B will receive 30ML 5% glucose water
干预措施: Glucose water 5% (Other)
结局指标
主要结局
The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery)
时间窗: From the time of injection and up to 2 hours after delivery
The volume of blood loss vaginally will be measured by weighing a specially prepared pad applied beneath the delivered women buttocks before the delivery of the fetus. An electronic scale will be used to weigh the pads before and after 2 hours of the delivery. The quantity of blood (ml) will be = (weight of used materials - weight of materials prior to use)
次要结局
- Number of participant with Post Partum Hemorrhage(up to 2 hours after delivery)
- Number of participant with severe postpartum hemorrhage(up to 2 hours after delivery)
- Number of participant who will need additional uterotonic drugs to control blood loss(up to 2 hours after delivery)
- the mean length of third stage of labor in both groups(up to 30 minutes)
研究者
Shahla Alalaf
Professor
Hawler Medical University