- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03632824
Tranexamic Acid in Pregnancies With Vaginal Bleeding
Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kurdistan Region
-
Erbil, Kurdistan Region, Iraq, 44001
- Hawler Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: interventional arm
Tranexamic acid applied intravenously for 2 days followed by oral 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:
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7 days
|
Gestational age
Time Frame: up to 7 days postpartum
|
Newborn delivered before, at or after 20 weeks gestation in weeks
|
up to 7 days postpartum
|
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
|
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>
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
|
Up to fifth minutes of life
|
Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HawlerMU 27.7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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