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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

March 10, 2010
March 11, 2010
January 2, 2011
January 25, 2011
January 25, 2011
September 2009
August 2010   (Final data collection date for primary outcome measure)
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward [ Time Frame: During the procedure and within 2 hours afterwards ]
Same as current
Complete list of historical versions of study NCT01085006 on ClinicalTrials.gov Archive Site
Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery [ Time Frame: First 24 hours ]
Same as current
Not Provided
Not Provided
 
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hemorrhage
  • Drug: Tranexamic acid
    Tranexamic acid in cases, normal saline in controls
  • Drug: Normal saline
    Tranexamic acid in cases, normal saline in controls
  • Experimental: Tranexamic acid
    Intervention: Drug: Tranexamic acid
  • Placebo Comparator: normal saline infusion
    Intervention: Drug: Normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
September 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01085006
830
Yes
Not Provided
Not Provided
Laleh Eslamian/ Associated professor/obstetrician &gynecologist, Associated Prof
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Laleh Eslamian, MD Associated Prof, Obstetrician & Gynecologist
Tehran University of Medical Sciences
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP