Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa

Study Overview
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Brief Summary
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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.

Official Title
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Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, PR China

Conditions
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Hemorrhage, Postpartum, Placenta Previa

Intervention / Treatment
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* Drug: Tranexamic acid
* Other: 0.9% sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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 | Drug: Tranexamic acid<br>* 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<br>|
| Placebo Comparator: control group<br>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 | Other: 0.9% sodium chloride<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PPH | 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 . | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean total calculated blood loss | 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 | Day 2 | 
| mean gravimetrically estimated blood loss | estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container | postpartum 24 hours | 
| Number of Participants with additional uterotonic agents treatment | additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al | baseline | 
| incidence of postpartum transfusion | include RBC, plasma, platelet, cryo et al | baseline | 
| incidence of postpartum iron perfusion |  | baseline | 
| incidence of hypovolemic shock related to PPH |  | baseline | 
| incidence of interventional therapy | include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al | baseline | 
| incidence of transfer to intensive care unit |  | baseline | 
| Number of Participants with additional operations performed outside cesarean section | Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al | baseline | 
| incidence of maternal death from any cause |  | week 6 | 
| incidence of hospital readmission |  | baseline | 
| mean peripartum change in hemoglobin | the difference between the hemoglobin levels before delivery and at D2 | Day 2 | 
| mean peripartum change in hematocrit levels | the difference between the hematocrit levels before delivery and at D2 | Day 2 | 
| incidence of infectious complications | include endometritis, surgical-site infection, or pelvic abscess within 6 weeks post partum | week 6 | 
| incidence of maternal thromboembolic events | including venous, arterial, or ischemic stroke or myocardial infarction within 6 weeks post partum | week 6 |