Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women with Placenta Previa
- Conditions
- Placenta PreviaHemorrhage, Postpartum
- Interventions
- Other: 0.9% sodium chlorideDrug: Tranexamic acid
- Registration Number
- NCT05811676
- Lead Sponsor
- Guangzhou Medical University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1680
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group 0.9% sodium chloride 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 study group Tranexamic acid 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
- Primary Outcome Measures
Name Time Method Incidence of PPH 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 .
- Secondary Outcome Measures
Name Time Method mean gravimetrically estimated blood loss postpartum 24 hours estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container
mean total calculated blood loss Day 2 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
Number of Participants with additional uterotonic agents treatment baseline additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al
incidence of postpartum iron perfusion baseline Number of Participants with additional operations performed outside cesarean section baseline Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al
incidence of maternal death from any cause week 6 incidence of postpartum transfusion baseline include RBC, plasma, platelet, cryo et al
incidence of interventional therapy baseline include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al
incidence of transfer to intensive care unit baseline incidence of hypovolemic shock related to PPH baseline incidence of hospital readmission baseline mean peripartum change in hematocrit levels Day 2 the difference between the hematocrit levels before delivery and at D2
incidence of maternal thromboembolic events week 6 including venous, arterial, or ischemic stroke or myocardial infarction within 6 weeks post partum
mean peripartum change in hemoglobin Day 2 the difference between the hemoglobin levels before delivery and at D2
incidence of infectious complications week 6 include endometritis, surgical-site infection, or pelvic abscess within 6 weeks post partum
Trial Locations
- Locations (27)
Huadu District People's Hospital of Guangzhou
🇨🇳Guangzhou, China
The Fifth Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
Zhuhai Women and Children's Hospital
🇨🇳Guangzhou, China
Shenzhen Maternal ＆ Child Healthcare Hospital Affiliated Southern Medical University
🇨🇳Shenzhen, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Northwest Women's and Children's Hospital
🇨🇳Xi'an, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Xinjiang, China
Urumqi Maternal and Child Health Care Hospital
🇨🇳Xinjiang, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Foshan Women and Children Hospital
🇨🇳Foshan, China
Dongguan Maternal and Child Health Care Hospital
🇨🇳Dongguan, China
The Tenth Affiliated Hospital of Southern Medical University; Dongguan People's Hospital
🇨🇳Dongguan, China
Peking University First Hospital
🇨🇳Beijing, China
Boai Hospital of Zhongshan
🇨🇳Guangzhou, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
Obstetrics Department, the Maternal and Child Health Hospital of Hunan Province
🇨🇳Hunan, China
Nanfang Hospital, Southern Medical University, Guangzhou
🇨🇳Guangzhou, China
Peking Union Medical College
🇨🇳Beijing, China
Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Dalian Women and Children's Medical Group
🇨🇳Dalian, China
Women and Children's Hospital of Chongqing Medical University
🇨🇳Chongqing, China
The first Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University
🇨🇳Jinan, China
Tianjin Central Hospital of Gynecology Obsterics
🇨🇳Tianjin, China
Shenzhen Baoan Women's and Children's Hospital
🇨🇳Shenzhen, China
Shijiazhuang Obstetrics and Gynecology Hospital
🇨🇳Shijiazhuang, China