The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery

Phase 1

Completed

• Conditions: Hemorrhage
• Interventions: Drug: Normal saline; Drug: Tranexamic acid

• Registration Number: NCT01085006
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2010-11
• Results First Submitted: 2011-01-02
• Results First Submitted QC: 2011-01-02
• Last Update Submitted: 2011-01-02
• Results First Posted: 2011-01-25
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Term pregnancy
2. Single fetus
3. Maximally only one previous cesarean delivery

Exclusion Criteria

1. More than one previous cesarean delivery
2. Hx of other abdominal or pelvic surgery
3. Hx of medical disorders
4. Hx of thromboembolic disorders
5. Polyhydramnios
6. Macrosomia
7. Preeclampsia
8. Hx of sensitivity to Tranexamic acid
9. Abnormal Pt, PTT, PT or INR

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline infusion	Normal saline	-
Tranexamic acid	Tranexamic acid	-

Primary Outcome Measures

Name	Time	Method
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward	During the procedure and within 2 hours afterwards

Secondary Outcome Measures

Name	Time	Method
Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery	First 24 hours

Trial Locations

Locations (1)

Laleh Eslamian; 🇮🇷 Tehran, Iran, Islamic Republic of