Tranexamic Acid in Pregnancies With Vaginal Bleeding

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

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

Study Overview

• Status: Completed
• Conditions: Vaginal Bleeding During Pregnancy
• Intervention / Treatment: Drug: Tranexamic Acid

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 Type: Interventional
• Enrollment (Anticipated): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan Region
    • Erbil, Kurdistan Region, Iraq, 44001
      • Hawler Medical University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cessation of vaginal bleeding as self-reported by women	Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format	7 days
Gestational age	Newborn delivered before, at or after 20 weeks gestation in weeks	up to 7 days postpartum
Rate of perinatal deaths	total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life	7 dya after delivery
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>	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	Up to fifth minutes of life

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 18, 2020

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 11, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 18, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Antepartum bleeding; Perinatal morbidity; Perinatal mortality; Preterm labor
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: HawlerMU 27.7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No