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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am over 34 weeks pregnant and planning a vaginal birth.
Select...
I am a woman scheduled for a C-section after 34 weeks of pregnancy.
Select...
I am a woman aged between 18 and 50.
Select...
I am a woman with a BMI over 50 planning to give birth.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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
243 Previous Clinical Trials
453,654 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction Morbidly Obese as a viable treatment option?

"Morbidly Obese received a score of 3, as there is clinical evidence to suggest efficacy and rounds of data which attest the safety."

Answered by AI

Does the protocol of this experiment permit participation from adults?

"The parameters for this trial only permit those aged 18 to 50. Alternatively, 53 trials are available for minors and 283 studies are open to patients over 65 years old."

Answered by AI

Are there any openings available to join this trial?

"Correct. According to clinicaltrials.gov, this study was officially opened on December 28th 2022 and is currently recruiting participants from one site with a desired sample size of 120 individuals."

Answered by AI

What is the current number of volunteers for this research endeavor?

"Affirmative, data found on clinicaltrials.gov confirms that the trial is actively enrolling patients. It was initially announced on December 28th 2022 and most recently updated January 23rd 2023 with a target of 120 participants across one site."

Answered by AI

Do I fulfill the prerequisites to join this clinical examination?

"This study seeks 120 individuals with postpartum hemorrhage that are between 18 and 50 in age. To be eligible for the trial, women must meet these qualifications: undergoing elective or non-urgent cesarean delivery greater than 34+0 weeks gestation; at > 34 weeks of gestation during a vaginal delivery; morbidly obese (BMI > 50) through either a vaginal or cesarean delivery; aged between 18 to 50 years old; normal serum creatinine levels (< 0.9)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prevention of Postpartum Hemorrhage With Tranexamic Acid (Phase 2)
Jaclyn Phillips 2022. "Prevention of Postpartum Hemorrhage With Tranexamic Acid (Phase 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370820.
~7 spots leftby Jun 2024
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