Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

Shanghai First Maternity and Infant Hospital

Status and phase: Unknown; Phase 4

Conditions: Postpartum Hemorrhage， Cesarean Section

Treatments: Drug: Placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02936661

ShanghaiFMIH-TXA1

Details and patient eligibility

About

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.

Enrollment: 6,700 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6,700 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section

Treatment:

Drug: Tranexamic Acid

placebo

Placebo Comparator group

Description:

NS 10ml IV in 2 minutes after the baby delivered during ceasarean section

Treatment:

Drug: Placebo