Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, PR China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,732
- 试验地点
- 27
- 主要终点
- Incidence of PPH
研究概览
简要总结
Many RCT(randomized controlled trial) studies reported that tranexamic acid reduced blood loss in women who had elective cesareans. However, most of these elective cesareans are without high-risk factors of postpartum hemorrhage, such as placenta previa. The prophylactic use of tranexamic acid in the placenta previa is not clear.
studies had poor quality and lacked adequate power to assess severe adverse events.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age of 18 years or older
- •Diagnosed with Placenta previa before cesarean delivery by ultrasound（Placenta previa defined by a placental edge below 20mm from internal cervical os diagnosed at the most recent transvaginal ultrasound examination before delivery）
- •Gestational age ≥ 34 weeks
- •Available venous hematocrit value in the week before the cesarean
- •Prenatal hemoglobin level in the week before the cesarean > 90 g/l
- •Undergoing cesarean delivery
- •Signed informed consent
排除标准
- •Known hypersensitivity to tranexamic acid or concentrated hydrochloric acid
- •History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial thrombosis (angina pectoris, myocardial infarction, or stroke)
- •History of epilepsy or seizure
- •Any known active cancer, active cardiovascular, renal, or liver disorders
- •Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease
- •Sickle cell disease
- •Severe hemorrhagic disease
- •Administration of low-molecular-weight heparin or antiplatelet agents within one week prior to delivery
- •Severe coagulation disorders with prothrombin time or activated partial thromboplastin time exceeding the upper limit of normal, or platelet count less than 80×109/L
- •placenta abruption
- •In-utero fetal death
- •Eclampsia or HELLP syndrome
- •Acquired color vision deficiency or subarachnoid hemorrhage
- •Severe bleeding with estimated blood loss exceeding 500 ml, within 12 hours before cesarean delivery
- •Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome
- •Participation in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism or the study intervention potentially affects postpartum bleeding or thromboembolism
研究组 & 干预措施
study group
Intravenous administration of 10 mL (1 g of tranexamic acid) diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
干预措施: Tranexamic acid (Drug)
control group
Intravenous administration of 10 mL placebo (0.9% sodium chloride), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
干预措施: 0.9% sodium chloride (Other)
结局指标
主要结局
Incidence of PPH
时间窗: Day 2
defined by a calculated estimated blood loss \> 1000 mL \[Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)\] or red blood cell (RBC) transfusion before day 2 postpartum .
次要结局
- mean total calculated blood loss(Day 2)
- mean gravimetrically estimated blood loss(postpartum 24 hours)
- Number of Participants with additional uterotonic agents treatment(baseline)
- incidence of postpartum transfusion(baseline)
- incidence of postpartum iron perfusion(baseline)
- incidence of hypovolemic shock related to PPH(baseline)
- incidence of interventional therapy(baseline)
- incidence of transfer to intensive care unit(baseline)
- Number of Participants with additional operations performed outside cesarean section(baseline)
- incidence of maternal death from any cause(week 6)
- incidence of hospital readmission(baseline)
- mean peripartum change in hemoglobin(Day 2)
- mean peripartum change in hematocrit levels(Day 2)
- incidence of infectious complications(week 6)
- incidence of maternal thromboembolic events(week 6)
研究者
Dunjin Chen
Department of Obstetrics and Gynecology, The Third Affiliated Hospital
Guangzhou Medical University