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Antifibrinolytic

Tranexamic Acid for Postpartum Hemorrhage

Phase 2
Recruiting
Led By Homa K Ahmadzia, MD
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women at > 34 weeks of gestation undergoing vaginal delivery
Women who are undergoing elective or non-urgent cesarean delivery greater than 34+0 weeks gestation
Must not have
Women with inherited thrombophilia or preexisting conditions that predispose them to thromboembolic events (i.e. lupus, antiphospholipid syndrome)
Women with a subarachnoid hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trialwill investigate if the dose of a drug (TXA) given to pregnant women at the time of delivery affects the concentration of the drug in their blood.

Who is the study for?
This trial is for women aged 18-50, over 34 weeks pregnant, undergoing elective cesarean or vaginal delivery. It includes morbidly obese women (BMI > 50). Participants must have normal kidney function and no history of thrombosis, liver dysfunction, seizure disorders, multiple gestations, or color vision defects.
What is being tested?
The study tests Tranexamic acid (TXA) to prevent postpartum hemorrhage. Part one determined the optimal dose; part two compares how TXA works when given through IV or IM before cord clamping in different patient groups including a control group with no medication.
What are the potential side effects?
Tranexamic acid may cause side effects such as nausea, diarrhea, vomiting. Rare but serious risks include blood clots leading to deep vein thrombosis or stroke especially in individuals predisposed to clotting disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 34 weeks pregnant and planning a vaginal birth.
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I am a woman scheduled for a C-section after 34 weeks of pregnancy.
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I am a woman aged between 18 and 50.
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I am a woman with a BMI over 50 planning to give birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a genetic condition or another illness that increases my risk of blood clots.
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I am a woman who has had a bleeding in the space around my brain.
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I am younger than 18 or older than 50.
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I have developed color vision problems.
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My kidney function is impaired with high creatinine levels.
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I have had a blood clot in an artery or vein.
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I have had liver problems in the past.
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I have an active blood clotting disorder.
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I have a history of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postpartum Hemorrhage

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116
22%
Readmissions
14%
Postoperative infections
10%
Re-operations
4%
Thromboembolic events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Tranexamic Group

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Vaginal DeliveryExperimental Treatment1 Intervention
Group II: Morbidly ObeseExperimental Treatment1 Intervention
Group III: Cesarean DeliveryExperimental Treatment1 Intervention
Group IV: No TXAActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor
252 Previous Clinical Trials
461,030 Total Patients Enrolled
3 Trials studying Postpartum Hemorrhage
349 Patients Enrolled for Postpartum Hemorrhage
Homa K Ahmadzia, MDPrincipal InvestigatorGeorge Washington University

Media Library

Tranexamic acid (Antifibrinolytic) Clinical Trial Eligibility Overview. Trial Name: NCT05370820 — Phase 2
Postpartum Hemorrhage Research Study Groups: Cesarean Delivery, Vaginal Delivery, Morbidly Obese, No TXA
Postpartum Hemorrhage Clinical Trial 2023: Tranexamic acid Highlights & Side Effects. Trial Name: NCT05370820 — Phase 2
Tranexamic acid (Antifibrinolytic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370820 — Phase 2
~41 spots leftby Nov 2025
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