Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section
Phase 4
- Conditions
- Postpartum Hemorrhage， Cesarean Section
- Interventions
- Drug: Placebo
- Registration Number
- NCT02936661
- Lead Sponsor
- Shanghai First Maternity and Infant Hospital
- Brief Summary
It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 6700
Inclusion Criteria
- gestational week more than 37;
- to delivery by cesarean section;
- informed consent form signed
Exclusion Criteria
- Any known renal or liver disorders
- History of venous or arterial thrombosis
- Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker.
- Do cesarean section because of active bleeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo NS 10ml IV in 2 minutes after the baby delivered during ceasarean section Tranexamic acid Tranexamic Acid Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section
- Primary Outcome Measures
Name Time Method postpartum hemorrhage 24h after the cesarean section
- Secondary Outcome Measures
Name Time Method the amount of postpartum bleeding 24h after the cesarean section