The Effect of Oral Tranexamic Acid Plus, Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- the amount of blood loss
研究概览
简要总结
The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery
详细描述
Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.
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)
盲法说明
This study was a prospective double-blind randomized study
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.
排除标准
- •were gestational age<37 weeks,
- •genital tract trauma,
- •coagulation defect,
- •women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
- •known hypersensitivity to carbetocin or oxytocin.
研究组 & 干预措施
TA plus misoprostol
Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm
干预措施: misoprostol (Drug)
TA plus misoprostol
Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm
干预措施: TA (Drug)
Carbetocin
Patient receives 100 mic gm carbetocin IV
干预措施: Carbetocin (Drug)
结局指标
主要结局
the amount of blood loss
时间窗: 6 hours post delivery
the amount of blood loss by gm calculated by gravimetric methods
次要结局
- number of patients loss more than 1000 ml blood(24 hours post delivery)
- need of uterotonics(24 hours post delivery)
研究者
hany farouk
lecturer
Aswan University Hospital