search
Back to results

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

Primary Purpose

Hemorrhage

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Tranexamic acid
Normal saline
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemorrhage focused on measuring cesarean delivery, Tranexamic acid, hemorrhage, Spinal analgesia, 1-the amount of hemorrhage during cesarean delivery, 2-the amount of hemorrhage in the first 2 hours of cesarean delivery, 3-the amount of hemorrhage in the first 24 hour after cesarean delivery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Laleh Eslamian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic acid

normal saline infusion

Arm Description

Outcomes

Primary Outcome Measures

The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward

Secondary Outcome Measures

Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery

Full Information

First Posted
March 10, 2010
Last Updated
January 2, 2011
Sponsor
Tehran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01085006
Brief Title
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
Official Title
The Effect of Tranexamic Acid Administration on Postpartum Hemorrhage During and After Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
cesarean delivery, Tranexamic acid, hemorrhage, Spinal analgesia, 1-the amount of hemorrhage during cesarean delivery, 2-the amount of hemorrhage in the first 2 hours of cesarean delivery, 3-the amount of hemorrhage in the first 24 hour after cesarean delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Title
normal saline infusion
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Tranexamic acid in cases, normal saline in controls
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Tranexamic acid in cases, normal saline in controls
Primary Outcome Measure Information:
Title
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward
Time Frame
During the procedure and within 2 hours afterwards
Secondary Outcome Measure Information:
Title
Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery
Time Frame
First 24 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Term pregnancy Single fetus Maximally only one previous cesarean delivery Exclusion Criteria: More than one previous cesarean delivery Hx of other abdominal or pelvic surgery Hx of medical disorders Hx of thromboembolic disorders Polyhydramnios Macrosomia Preeclampsia Hx of sensitivity to Tranexamic acid Abnormal Pt, PTT, PT or INR
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laleh Eslamian, MD
Organizational Affiliation
Associated Prof, Obstetrician & Gynecologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laleh Eslamian
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs