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

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ClinicalTrials.gov Identifier: NCT01085006
Recruitment Status : Completed
First Posted : March 11, 2010
Results First Posted : January 25, 2011
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
Tehran University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Hemorrhage Drug: Tranexamic acid Drug: Normal saline Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Tranexamic Acid Administration on Postpartum Hemorrhage During and After Cesarean Delivery
Study Start Date : September 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward [ Time Frame: During the procedure and within 2 hours afterwards ]

Secondary Outcome Measures :
  1. Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery [ Time Frame: First 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085006


Locations
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Iran, Islamic Republic of
Laleh Eslamian
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Laleh Eslamian, MD Associated Prof, Obstetrician & Gynecologist
More Information
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Responsible Party: Laleh Eslamian/ Associated professor/obstetrician &gynecologist, Associated Prof
ClinicalTrials.gov Identifier: NCT01085006    
Other Study ID Numbers: 830
First Posted: March 11, 2010    Key Record Dates
Results First Posted: January 25, 2011
Last Update Posted: January 25, 2011
Last Verified: November 2010
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:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
 Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants