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Tranexamic Acid in Pregnancies With Vaginal Bleeding

Primary Purpose

Vaginal Bleeding During Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Bleeding During Pregnancy focused on measuring Antepartum bleeding, Perinatal morbidity, Perinatal mortality, Preterm labor

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hawler Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

interventional arm

comparative group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Gestational age
Newborn delivered before, at or after 20 weeks gestation in weeks
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
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

Secondary Outcome Measures

Full Information

First Posted
July 27, 2018
Last Updated
January 18, 2020
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03632824
Brief Title
Tranexamic Acid in Pregnancies With Vaginal Bleeding
Official Title
Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Bleeding During Pregnancy
Keywords
Antepartum bleeding, Perinatal morbidity, Perinatal mortality, Preterm labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
139 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interventional arm
Arm Type
Experimental
Arm Description
Tranexamic acid applied intravenously for 2 days followed by oral tranexamic acid
Arm Title
comparative group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Trenaxa , Manufacturer Macleods Pharmaceuticals, TRANSAMIN , NIKOLAKOPOULOS A.E. GALATSIOU AVENUE, Athens
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Cessation of vaginal bleeding as self-reported by women
Description
Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format
Time Frame
7 days
Title
Gestational age
Description
Newborn delivered before, at or after 20 weeks gestation in weeks
Time Frame
up to 7 days postpartum
Title
Rate of perinatal deaths
Description
total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life
Time Frame
7 dya after delivery
Title
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>
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariana K. Jawad
Organizational Affiliation
Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawler Medical University
City
Erbil
State/Province
Kurdistan Region
ZIP/Postal Code
44001
Country
Iraq

12. IPD Sharing Statement

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Tranexamic Acid in Pregnancies With Vaginal Bleeding

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