Tranexamic Acid in Pregnant Women With Placentae Previa: A Double-blind, Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Favorable perinatal outcome
研究概览
简要总结
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women
详细描述
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Two similar size syringes will be prepared and labeled as A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and syringe B (placebo group) containing 30 mL of 5% glucose water.
The 2 groups of syringes will be labeled with different numbers not known by the investigator or the patient
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
- •Pregnant at 28 weeks gestation and more
- •Vaginal bleeding due to placenta previa
- •Stable hemodynamically
- •Accept to participate in the trial
排除标准
- •Hypersensitivity to tranexamic acid
- •Acquired defective color vision
- •History of venous thromboembolism
- •Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease)
- •Refused to participate in the trial
研究组 & 干预措施
Tranexamic acid group
This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants.
干预措施: Tranexamic acid injection (Drug)
Glucose water group
Participants will receive 30 mL of 5% glucose water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care.
干预措施: Glucose water 5% (Other)
结局指标
主要结局
Favorable perinatal outcome
时间窗: 7 days post partum
Delivery of active newborn at or more than 36 weeks gestation
Prolong pregnancy to 36 weeks
时间窗: Up to delivery of the fetus
Decreased vaginal bleeding may prolong pregnancy
To stope or decrease vaginal bleeding
时间窗: Up to time of delivery
Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa
次要结局
未报告次要终点
研究者
SHAHLA KAREEM ALALAF
Professor
Hawler Medical University