Tranexamic Acid in Pregnancies With Vaginal Bleeding

NCT03632824 | Completed DMC

• 1 other identifier: HawlerMU 27.7
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaginal Bleeding During Pregnancy

Keywords

Antepartum bleeding; Perinatal morbidity; Perinatal mortality; Preterm labor

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

interventional arm

EXPERIMENTAL

Tranexamic acid applied intravenously for 2 days followed by oral tranexamic acid

Drug: Tranexamic Acid

comparative group

PLACEBO COMPARATOR

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

Interventions

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 .

Also known as: Trenaxa , Manufacturer Macleods Pharmaceuticals, TRANSAMIN , NIKOLAKOPOULOS A.E. GALATSIOU AVENUE, Athens

comparative group; interventional arm

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Medical University

Erbil, Kurdistan Region, 44001, Iraq

Location

MeSH Terms

Conditions

Perinatal Death; Obstetric Labor, Premature

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ariana K. Jawad

  Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Tranexamic acid was prescribed for pregnant women with vaginal bleeding of unknown etiology in second and third trimester (13-34 weeks) gestation

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 15, 2018
• Study Start: February 1, 2016
• Primary Completion: January 15, 2020
• Study Completion: January 18, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

IR (1)