Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Amount of bleeding during antepartum bleeding attacks
研究概览
简要总结
200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).
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)
盲法说明
Visually-identical drug and placebo tablets will be assigned to each participant using SNOSE congaing assignment code.
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
- •Gestational age 28 weeks of gestation.
- •Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan.
- •Haemodynamically stable pregnant women.
- •Maternal age:20-40years old.
- •Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage.
排除标准
- •Multiple pregnancy.
- •Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants .
- •Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
- •Women have hypersensitivity or any contraindication to use of tranexamic acid.
- •Pregnant women with placenta previa with doppler showing morbidly adherent placenta.
研究组 & 干预措施
Tranexamic acid group
100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
干预措施: Tranexamic acid tablets (Drug)
Placebo group
100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Amount of bleeding during antepartum bleeding attacks
时间窗: 9 weeks GA
Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.
次要结局
- Number of PRBCs units required during antepartum blood transfusion(9 weeks GA)
- Number of women requiring antepartum blood transfusion(9 weeks GA)
- Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery(9 weeks GA)
- Gestational age at delivery(9 weeks GA)
- Neonatal intensive care unit (NICU) admission(9 weeks)
研究者
Amal Ramadan
Clinical fellow of Obstetrics & Gynecology
Ain Shams University