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Tranexamic Acid in Pregnancies With Vaginal Bleeding

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ClinicalTrials.gov Identifier: NCT03632824
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ariana Jawad, Hawler Medical University

Brief Summary:
Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.

Condition or disease Intervention/treatment Phase
Vaginal Bleeding During Pregnancy Drug: Tranexamic Acid Not Applicable

Detailed Description:
Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal mortality. Hemorrhage in pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis, and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is Category B. It crosses the placenta however; its lack of effect on plasminogen activator activity in the vascular cell wall protects the fetus and newborn from potential thromboembolic complications.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Tranexamic acid was prescribed for women with abnormal vaginal bleeding in the first trimester less than 20 weeks gestation (threatened and recurrent miscarriage) and Antepartum hemorrhage (abruption , placenta previa, and unknown causes for vaginal bleeding)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Pregnancies With Early and Late Onset Vaginal Bleeding:One Arm Clinical Trial
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : November 2, 2018
Actual Study Completion Date : November 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: interventional arm
Tranexamic acid applied intravenously for 2 days followed by oral tranexamic acid
Drug: Tranexamic Acid

One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days .

follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again .

Other Names:
  • Trenaxa , Manufacturer Macleods Pharmaceuticals
  • TRANSAMIN , NIKOLAKOPOULOS A.E. GALATSIOU AVENUE, Athens




Primary Outcome Measures :
  1. Cessation of vaginal bleeding as self-reported by women [ Time Frame: 7 days ]
    Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format

  2. Gestational age [ Time Frame: up to 7 days postpartum ]
    Newborn delivered before, at or after 20 weeks gestation in weeks

  3. Rate of Stillbirths [ Time Frame: at delivery ]
    Number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation)

  4. Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed <0-3>, moderately depressed<4-6> and excellent condition<7-10> [ Time Frame: Up to fifth minutes of life ]
    Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed 0-3, moderately depressed 4-6 and excellent condition 7-10


Secondary Outcome Measures :
  1. Rate of of Tranexamic acid side effects [ Time Frame: up to 24 hours ]
    Visual abnormalities, Hypotension ,Nausea , Vomiting ,Diarrhea ,Anaphylaxis

  2. Rate of thromboembolic events [ Time Frame: up to one week after delivery ]
    Venous thromboembolism ( deep vein thrombosis and pulmonary embolism) as a side effects for tranexamic acid



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Ages Eligible for Study:   15 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant woman having vaginal bleeding
  • First,second and third trimester
  • Primigraivid, multiparous and grand multiparous woman
  • Accept to participate in the trial

Exclusion Criteria:

  • Hypersensitivity to tranexamic acid
  • Women with acquired defective color vision
  • History of venous thromboembolism
  • Refused to participate

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): NCT03632824


Locations
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Iraq
Hawler Medical University
Erbil, Kurdistan Region, Iraq, 44001
Sponsors and Collaborators
Hawler Medical University
Investigators
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Principal Investigator: Ariana K. Jawad Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology

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Responsible Party: Ariana Jawad, Assistant Professor, Hawler Medical University
ClinicalTrials.gov Identifier: NCT03632824     History of Changes
Other Study ID Numbers: HawlerMU 27.7
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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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 Ariana Jawad, Hawler Medical University:
Placental abruption
Placenta previa
Threatened
Miscarriage
Additional relevant MeSH terms:
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Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants