Morbidly Obese for Postpartum Hemorrhage

George Washington University Hospital, Washington, United States
Postpartum HemorrhageTranexamic acid - Drug
18 - 50

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.

Eligible Conditions
  • Postpartum Hemorrhage

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
Postpartum Hemorrhage
To determine adequate timing and formulation of TXA in prevention of postpartum hemorrhage (PPH) so that maternal benefit is maximized

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Tranexamic Group
14%Postoperative infections
4%Thromboembolic events
This histogram enumerates side effects from a completed 2012 Phase 4 trial (NCT00740116) in the Tranexamic Group ARM group. Side effects include: Readmissions with 22%, Postoperative infections with 14%, Re-operations with 10%, Thromboembolic events with 4%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

1 of 4
Morbidly Obese
1 of 4
Cesarean Delivery
1 of 4
Vaginal Delivery
1 of 4

Active Control

Experimental Treatment

120 Total Participants · 4 Treatment Groups

Primary Treatment: Morbidly Obese · No Placebo Group · Phase 2

Morbidly Obese
Experimental Group · 1 Intervention: Tranexamic acid · Intervention Types: Drug
Cesarean Delivery
Experimental Group · 1 Intervention: Tranexamic acid · Intervention Types: Drug
Vaginal Delivery
Experimental Group · 1 Intervention: Tranexamic acid · Intervention Types: Drug
No TXANoIntervention Group · 1 Intervention: No TXA · Intervention Types:
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

George Washington UniversityLead Sponsor
221 Previous Clinical Trials
172,857 Total Patients Enrolled
2 Trials studying Postpartum Hemorrhage
180 Patients Enrolled for Postpartum Hemorrhage
Homa K Ahmadzia, MDPrincipal InvestigatorGeorge Washington University

Eligibility Criteria

Age 18 - 50 · Female Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Are there any openings available to join this trial?

"Correct. According to, 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." - Anonymous Online Contributor

Unverified Answer

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

"Affirmative, data found on 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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.