Postpartum Hemorrhage， Cesarean Section
Conditions
Keywords
postpartum hemorrhage， cesarean section， tranexamic acid
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.
Interventions
DRUGTranexamic Acid
DRUGPlacebo
Sponsors
Shanghai First Maternity and Infant Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postpartum hemorrhage | 24h after the cesarean section |
Secondary
| Measure | Time frame |
|---|---|
| the amount of postpartum bleeding | 24h after the cesarean section |
Outcome results
None listed