The use of tranexamic acid to reduce blood loss during and after cesarean section

Tranexamic acid for prevention of postpartum hemorrhage in women undergoing elective cesarean section

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000313831

Enrollment

700

Registered

2012-03-20

Start date

2011-08-03

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Bleeding after delivery is still the leading cause of maternal deaths especially in low resourced countries. Rates of delivery by cesarean section are increasing.One in three to four women are delivered by cesarean section.This trial is looking for new strategies to reduce blood loss after delivery by cesarean section.Tranexamic acid is a drug which prevents or delays lysis of blood clots after its formation .The formation of blood clot at the site of placental separation inside the uterus is an important mechanism to prevent bleeding after placental separation.This randomized controlled trial aims to evaluate the effectiveness and safety of tranexamic acid given to women at cesarean section.

Interventions

Tranexamic acid (1gm)will be given slowly intravenously over 10 minutes before elective cesarean section

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

19 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

All pregnant women with single fetus planned to have elective cesarean section at greater than 36wks gestation

Exclusion criteria

1. History of medical disorders. 2. Preclampsia. 3. Antepartum hemorrhage. 3. History of thromboembolic disorders. 4. Polyhydramnios. 5. Macrosomia. 6. History of sensitivity to Tranexamic acid. 7. Patients taking anticoagulant therapy.

Outcome results