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NCT01085006 Clinical Trial

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

Hemorrhage Clinical Trial

Official title:
The Effect of Tranexamic Acid Administration on Postpartum Hemorrhage During and After Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01085006
Other study ID # 830
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 10, 2010
Last updated January 2, 2011
Start date September 2009
Est. completion date September 2010

Study information
Verified date November 2010
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date September 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic acid
Tranexamic acid in cases, normal saline in controls
• Normal saline
Tranexamic acid in cases, normal saline in controls

Locations
Country Name City State
Iran, Islamic Republic of Laleh Eslamian Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward During the procedure and within 2 hours afterwards Yes
Secondary Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery First 24 hours Yes
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