Postpartum Hemorrhage, Cesarean Section Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 6700 |
| Est. completion date | March 2019 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai First Maternity and Infant Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | postpartum hemorrhage | 24h after the cesarean section | No | |
| Secondary | the amount of postpartum bleeding | 24h after the cesarean section | No |