Double-blind, Randomized Controlled Trial to Assess the Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 4
- 主要终点
- Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm
研究概览
简要总结
This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women (125 per study arm).
The objective of the study is to determine the efficacy and tolerability of oral tranexamic acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH). Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be randomized to receive either tranexamic acid or placebo, both in tablet form. All participants will receive 800 mcg sublingual misoprostol (4 tablets 200mcg each).
The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding without recourse to further treatment in significantly more women.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who delivery vaginally
- •Women who experience PPH defined as blood loss ≥700ml
- •Women capable of giving consent
排除标准
- •Clear contraindication for tranexamic acid such as known allergy or thromboembolic event during pregnancy
- •Women delivering via cesarean section
- •Provider feels that the woman, at presentation for delivery, is not in a position to give appropriate informed consent
研究组 & 干预措施
Tranexamic acid
1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol
干预措施: Tranexamic Acid (Drug)
Tranexamic acid
1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol
干预措施: Misoprostol (Drug)
Placebo
oral placebo + 800 mcg sublingual misoprostol
干预措施: Placebo (Drug)
Placebo
oral placebo + 800 mcg sublingual misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm
时间窗: 20 minutes after initial study treatment
次要结局
- Mean/median blood loss(at two hours after treatment)
- Adverse events(48 hours after delivery)
- Proportion of women who experience side effects(2 hours after delivery)
- Proportion of women with controlled bleeding(At various time intervals after study treatment (20, 40, 60, 120 mins))
- Rate of severe PPH(2 hours after delivery)
- Use of uterotonic agents after initial treatment(2 hours after delivery)
- Proportion of women who received a serious interventions(2 hours after delivery)
- Proportion of women who received additional drugs(2 hours after delivery)
- Proportion of women who receive additional intervention(2 hours after delivery)
- Proportion of women who find the treatment tolerable(48 hours after delivery)