NCT05370820

Brief Summary

In part 1 of the study, the investigators conducted a prospective, open-label, dose finding pharmacokinetic (PK) study in 43 pregnant 3rd trimester women scheduled for non-emergent cesarean section. The investigators administered three doses of the drug (5 mg/kg, 10 mg/kg and 15 mg/kg) in an escalating fashion by cohort with the lowest dose first. The drug was administered intravenously at the time of umbilical cord clamping for a non-emergent cesarean section. A maximum of 1 g was administered. TXA serum levels at several time points after delivery were assayed to see if they reach the target plasma concentration of 10 ug/mL. A PK model was constructed for determining the optimal TXA dose administered at parturition. In part 2 of the study, the investigators aim to compare PKPD endpoints using prophylactic TXA via IV and IM routes administered pre-cord clamp. The investigators will administer 1 g TXA within 10 minutes of skin incision via intravenous infusion (up to n=15), intravenous bolus \< 2 minutes (up to n=15) and intramuscular injection (up to n=15). The investigators will target women undergoing scheduled cesarean delivery \> 34 weeks gestation, women undergoing vaginal delivery \> 34 weeks of gestation and morbidly obese women (BMI\>=40) undergoing either a vaginal or cesarean delivery. The investigators will use advanced modeling techniques to determine time to achieve PKPD targets and duration remaining at those targets. The goal will be to determine how the optimal dose may vary if route of administration is modified. The investigators plan to enroll 45 patients in addition to the 43 that were enrolled during part 1. Our goal is to 30 participants, but the investigators will enroll 45 to account for lost to follow-up. The investigators also aim to enroll 30 patients undergoing vaginal delivery and 30 morbidly obese women (BMI \>= 40) undergoing either a vaginal or cesarean delivery but the investigators will enroll 45 patients for each of these groups to account for loss to follow up. In addition, the investigators will enroll 30 pregnant patients receiving no medication acting as the control group, but the investigators will enroll 45 to account for loss to follow up.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
12mo left

Started Dec 2022

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Dec 2022Jun 2027

First Submitted

Initial submission to the registry

April 22, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

December 28, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

April 22, 2022

Last Update Submit

March 23, 2026

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • PK Model Parameter Estimates

    Data obtained from assays of TXA in blood, dose group and patient characteristics; parameter estimates in 2 compartment model includes the clearance of the drug (L/hr).

    Different time points ranging from surgery (T0) to 1 day postpartum.

  • Pharmacodynamics of Tranexamic Acid

    PD model parameters included concentration of TXA causing 50% of maximal fractional inhibition (IC50).

    Different time points ranging from surgery (T0) to 1 day postpartum.

Secondary Outcomes (2)

  • Estimated Blood Loss

    During surgery

  • Safety Parameters

    During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum

Study Arms (4)

Cesarean Delivery

EXPERIMENTAL
Drug: Tranexamic acidOther: No intervention

Vaginal Delivery

EXPERIMENTAL
Drug: Tranexamic acidOther: No intervention

Morbidly Obese

EXPERIMENTAL
Drug: Tranexamic acidOther: No intervention

No TXA

NO INTERVENTION

Interventions

Tranexamic acidDRUG

Tranexamic Acid 1000 mg administered intravenously via infusion over 10 minutes.

Cesarean DeliveryMorbidly ObeseVaginal Delivery
No interventionOTHER

Control group with no administration of Tranexamic Acid.

Cesarean DeliveryMorbidly ObeseVaginal Delivery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who are scheduled to under medically indicated cesarean section at greater than 34+0 weeks gestation or women who are scheduled to undergo an elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists
  • Women who are indicated to have a vaginal delivery at \> 34+0 weeks gestation.
  • Pregnant women with normal serum creatinine (serum creatinine \< 0.9) within 2 weeks of estimated/scheduled delivery
  • Women between the ages of 18 and 50 years old
  • Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.

You may not qualify if:

  • active thrombotic or thromboembolic disease
  • a history of arterial or venous thromboembolic event
  • inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome, thrombocytosis or thrombophilic thrombocytopathy)
  • a subarachnoid hemorrhage
  • acquired defective color vision
  • history of seizure disorder
  • known renal dysfunction (serum creatinine = or \>0.9)
  • multiple gestations (twin or triplet pregnancies)
  • hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
  • history of liver dysfunction at the discretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Homa K Ahmadzia, MD

    Inova Health Care Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Homa K Ahmadzia, MD

CONTACT

706-776-6650homa.ahmadzia@inova.org

Jaclyn Phillips

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PI

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 12, 2022

Study Start

December 28, 2022

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(2)