Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Gestational age
研究概览
简要总结
Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.
详细描述
Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal mortality. Hemorrhage in pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis, and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B. Tranexamic acid has been used to decrease blood loss and treatment of intra partum blood loss in cesarean section also it has been used for prevention and management of postpartum hemorrhage after vaginal bleeding, regardless of whether the bleeding is due to genital tract trauma or other causes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant woman having vaginal bleeding
- •Second and third trimester of unknown etiology
- •No placenta previa, abruptio placentae, local cervical or vaginal causes for bleeding
- •Primigraivid, multiparous and grand multiparous woman
- •Accept to participate in the trial
排除标准
- •Hypersensitivity to tranexamic acid
- •Women with acquired defective color vision
- •History of venous thromboembolism
- •Refused to participate
研究组 & 干预措施
interventional arm
Tranexamic acid applied intravenously for 2 days followed by oral tranexamic acid
干预措施: Tranexamic Acid (Drug)
comparative group
expectant management, including admission to hospital, ultrasound examination at least twice a week, regular blood coagulation tests, fetal wellbeing , frequent ultrasound performing for placenta location ,betamethasone administration for whom delivery was suspected
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Gestational age
时间窗: up to 7 days postpartum
Newborn delivered before, at or after 20 weeks gestation in weeks
Rate of perinatal deaths
时间窗: 7 dya after delivery
total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life
Cessation of vaginal bleeding as self-reported by women
时间窗: 7 days
Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format
Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed <0-3>, moderately depressed<4-6> and excellent condition<7-10>
时间窗: Up to fifth minutes of life
Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed 0-3, moderately depressed 4-6 and excellent condition 7-10
次要结局
未报告次要终点
研究者
Ariana Jawad
Assistant Professor
Hawler Medical University