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

January 2, 2011 updated by: Tehran University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic acid
Drug: Tranexamic acid
Tranexamic acid in cases, normal saline in controls
Placebo Comparator: normal saline infusion
Drug: Normal saline
Tranexamic acid in cases, normal saline in controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward
Time Frame: During the procedure and within 2 hours afterwards
During the procedure and within 2 hours afterwards

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery
Time Frame: First 24 hours
First 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Laleh Eslamian, MD, Associated Prof, Obstetrician & Gynecologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

March 10, 2010

First Posted (Estimate)

March 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 2, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 830

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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