Tranexamic Acid in Pregnancies With Vaginal Bleeding

• ClinicalTrials.gov Identifier: NCT03632824
• Recruitment Status: Completed
• First Posted: August 15, 2018
• Last Update Posted: January 22, 2020
• Sponsor: Hawler Medical University
• Information provided by (Responsible Party): Ariana Jawad, Hawler Medical University

Study Description

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. 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 139 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Tranexamic acid was prescribed for pregnant women with vaginal bleeding of unknown etiology in second and third trimester (13-34 weeks) gestation
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials
• Actual Study Start Date: February 1, 2016
• Actual Primary Completion Date: January 15, 2020
• Actual Study Completion Date: January 18, 2020

Arms and Interventions

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
Placebo Comparator: comparative group; expectant management, including admission to hospital, ultrasound examination at least twice a week, regular blood coagulation tests, fetal wellbeing , frequent ultrasound performing for placenta location ,betamethasone administration for whom delivery was suspected	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

Outcome Measures

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 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 42 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Iraq

Hawler Medical University

Erbil, Kurdistan Region, Iraq, 44001

Sponsors and Collaborators

Hawler Medical University

Investigators

• Principal Investigator: Ariana K. Jawad; Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology

More Information

• Responsible Party: Ariana Jawad, Assistant Professor, Hawler Medical University
• ClinicalTrials.gov Identifier: NCT03632824
• Other Study ID Numbers: HawlerMU 27.7
• First Posted: August 15, 2018
• Last Update Posted: January 22, 2020
• Last Verified: January 2020

• 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:

Antepartum bleeding; Perinatal morbidity; Perinatal mortality; Preterm labor

Additional relevant MeSH terms:

Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Uterine Diseases; Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants