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Completed

NCT Number: NCT03632824

Tranexamic Acid in Pregnancies With Vaginal Bleeding

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

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Key information

Conditions

Vaginal Bleeding During Pregnancy Death Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hawler Medical University

Erbil, Kurdistan Region, 44001, Iraq

About this study

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. Tranexamic acid has been used to decrease blood loss and treatment of intra partum blood loss in cesarean section also it has been used for prevention and management of postpartum hemorrhage after vaginal bleeding, regardless of whether the bleeding is due to genital tract trauma or other causes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant woman having vaginal bleeding
  • Second and third trimester of unknown etiology
  • No placenta previa, abruptio placentae, local cervical or vaginal causes for bleeding
  • 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

Treatment and study plan

Tranexamic Acid

Drug

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 outcomes

  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 perinatal deaths

    Time frame: 7 dya after delivery

    total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life

  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

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2018
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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