Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

Shanghai First Maternity and Infant Hospital6,700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

6,700

Conditions

Postpartum Hemorrhage， Cesarean Section

Interventions

Tranexamic AcidDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

postpartum hemorrhage

Time frame: 24h after the cesarean section

Secondary Outcomes

the amount of postpartum bleeding

Time frame: 24h after the cesarean section

Data from ClinicalTrials.gov

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