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

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01085006
First received: March 10, 2010
Last updated: January 2, 2011
Last verified: November 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Hemorrhage
 Drug: Tranexamic acid
Drug: Normal saline
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Tranexamic Acid Administration on Postpartum Hemorrhage During and After Cesarean Delivery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward [ Time Frame: During the procedure and within 2 hours afterwards ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery [ Time Frame: First 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085006

Locations
Iran, Islamic Republic of
Laleh Eslamian
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Laleh Eslamian, MD Associated Prof, Obstetrician & Gynecologist
  More Information

No publications provided

Responsible Party: Laleh Eslamian/ Associated professor/obstetrician &gynecologist, Associated Prof
ClinicalTrials.gov Identifier: NCT01085006     History of Changes
Other Study ID Numbers: 830
Study First Received: March 10, 2010
Results First Received: January 2, 2011
Last Updated: January 2, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
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

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Tranexamic Acid
 Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013