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Trial record 29 of 419 for:    TRANEXAMIC ACID

Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03351686
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hanan Nabil, Mansoura University

Brief Summary:
postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality . Tranexamic acid is used in many studies in management of PPH in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Tranexamic Acid Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section, a Randomized Controlled Clinical Trial
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : April 15, 2017
Actual Study Completion Date : April 15, 2017

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Arm Intervention/treatment
Experimental: tranexamic acid group Drug: Tranexamic Acid
Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.

No Intervention: non tranexamic (control) group



Primary Outcome Measures :
  1. prevention of postpartum hemorrhage in high risk group [ Time Frame: intraoperative ]
    assessment of intraoperative blood loss



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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age of 28 weeks or more.
  • Chronic Hypertension.
  • Preeclapmsia -Eclampsia.
  • Multiple pregnancy.
  • Uterine Liomyomas.
  • Polyhydraminos.
  • Fetal macrosomia.
  • Associated Thrombocytopenia
  • History of postpartum hemorrhage.

Exclusion Criteria:

  • Patients with rheumatic heart disease.
  • Patients with history Cardiac Valve Replacement.
  • Current or past history of DVT.
  • Women on any anticoagulant therapy.
  • Sensitivity to tranexamic acid
  • Pregnancies with any abnormally implanted or located placenta.

Information from the National Library of Medicine

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): NCT03351686


Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Hanan Nabil, MD Mansoura University

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Responsible Party: Hanan Nabil, Assistant Professor, Mansoura University
ClinicalTrials.gov Identifier: NCT03351686     History of Changes
Other Study ID Numbers: MansuraU
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanan Nabil, Mansoura University:
tranexamic acid
Additional relevant MeSH terms:
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Tranexamic Acid
Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants