RECRUITING

Prevention of Postpartum Hemorrhage With Tranexamic Acid

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 gram was administered. TXA serum levels at several time points after delivery were assayed to see if they reach the target plasma concentration of 10 microg/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 1000 mg 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 greater than 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 investigatorsalso aim to enroll 30 patients undergoing vaginal delivery and 30 morbidly obese women (BMI \> 50) 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.

Official Title

Prevention of Postpartum Hemorrhage: Pharmacokinetics (PK) Abd Pharmacodynamics (PD) of Tranexamic Acid

Quick Facts

Study Start:2022-12-28
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05370820

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Women who are indicated to have a vaginal delivery at \> 34+0 weeks gestation.
  3. * Pregnant women with normal serum creatinine (serum creatinine \< 0.9) within 2 weeks of estimated/scheduled delivery
  4. * Women between the ages of 18 and 50 years old
  5. * Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
  1. * active thrombotic or thromboembolic disease
  2. * a history of arterial or venous thromboembolic event
  3. * inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome, thrombocytosis or thrombophilic thrombocytopathy)
  4. * a subarachnoid hemorrhage
  5. * acquired defective color vision
  6. * history of seizure disorder
  7. * known renal dysfunction (serum creatinine = or \>0.9)
  8. * multiple gestations (twin or triplet pregnancies)
  9. * hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
  10. * history of liver dysfunction at the discretion of the investigator

Contacts and Locations

Study Contact

Homa K Ahmadzia, MD
CONTACT
706-776-6650
homa.ahmadzia@inova.org
Jaclyn Phillips
CONTACT

Principal Investigator

Homa K Ahmadzia, MD
PRINCIPAL_INVESTIGATOR
Inova Health Care Services

Study Locations (Sites)

George Washington University Hospital
Washington, District of Columbia, 20037
United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
United States

Collaborators and Investigators

Sponsor: Inova Health Care Services

  • Homa K Ahmadzia, MD, PRINCIPAL_INVESTIGATOR, Inova Health Care Services

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-28
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2022-12-28
Study Completion Date2026-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Post Partum Hemorrhage