Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery

Effects of Tranexamic Acid on Post Partum Hemorrhage by Uterine Atony After Cesarean Section Delivery: a Randomized, Placebo Controlled Trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01599468

Enrollment

Registered

2012-05-16

Start date

2011-07-31

Completion date

2012-04-30

Last updated

2012-05-22

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

Conditions

Post Partum Hemorrhage

Keywords

post partum hemorrhage, transfusion, tranexamic acid

Brief summary

The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery. This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.

Interventions

DRUGTranexamic Acid

10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours

DRUGsaline serum

The Placebo group received normal saline with the same volumes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Inclusion criteria

* ASA1 parturients * aged from 20 to 40 * correct preoperative haemostatic status (prothrombine ratio \> 60 % and platelet rate \> 100 000), * cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of Sulprostone

Exclusion criteria

* abnormal placentation * severe pre-eclampsia * coagulopathy and uterine rupture * the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.

Design outcomes

Primary

Measure	Time frame
volume blood loss	within 5 days after delivery

Secondary

Measure	Time frame
transfusion rates.	within 5 days after delivery

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026