Tranexamic Acid in Pregnant Women With Abruptio Placenta: 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
- 116
- 试验地点
- 1
- 主要终点
- Hemostasis
研究概览
简要总结
Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality
详细描述
Abruption has been estimated to occur in 6.5 pregnancies per 1000 births, with an associated perinatal mortality rate of 119 per 1000 in the United States. A Cochrane database study revealed that there is no evidence from trials to show the best way to help pregnant women and their fetuses when there is a placental abruption. The baby may need to be delivered immediately, by cesarean section if alive, and often vaginally if the baby has died. Treatments include pain relief, blood transfusion, and monitoring. Bleeding during 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.
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
- Double (Participant, 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
- •24 weeks gestation and more
- •Stable hemodynamically
- •Accepted to participate
排除标准
- •Hypersensitivity to tranexamic acid
- •Defective color vision
- •History of venous thromboembolism
- •Pre-existing medical conditions that could affect pregnancy outcomes (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 Dextrose 5% in water 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)
Dextrose 5% in water group
Participants will receive 30 mL of Dextrose 5% in 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: Dextrose 5% in water (Other)
结局指标
主要结局
Hemostasis
时间窗: Up to time of delivery
complete or gradual cessation of vaginal bleeding
Gestational age
时间窗: at time of delivery
37 weeks and more
Favorable perinatal outcome
时间窗: up to 7 days post partum
viable newborn, birth weight of at least 2,500 grams, an Apgar score of at least 7, and no neonatal intensive care unit hospitalization. more, birth weight of 2.5 kg and more
次要结局
未报告次要终点
研究者
SHAHLA KAREEM ALALAF
Professor
Hawler Medical University