RecruitingPhase 2NCT05370820

Prevention of Postpartum Hemorrhage With Tranexamic Acid

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


Sponsor

Inova Health Care Services

Enrollment

120 participants

Start Date

Dec 28, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tranexamic acid — a medication that helps stop bleeding — can reduce the risk of heavy bleeding after childbirth (postpartum hemorrhage) in women having either a cesarean section or vaginal delivery. You may be eligible if... - You are between 18 and 50 years old and pregnant - You are scheduled for a medically indicated or elective cesarean section, or planning a vaginal delivery at or after 34 weeks - Your kidney function (serum creatinine) is normal within 2 weeks of delivery You may NOT be eligible if... - You have an active blood clot or history of thromboembolism - You have inherited clotting disorders or conditions like lupus or antiphospholipid syndrome - You have had a brain bleed (subarachnoid hemorrhage) - You have a seizure disorder - You have known kidney problems - You are carrying twins or triplets - You are allergic to tranexamic acid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTranexamic acid

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

DRUGTranexamic acid

Tranexamic Acid 1000 mg administered intravenously via push over 2 minutes.

DRUGTranexamic acid

Tranexamic Acid 1000 mg administered intramuscularly.

OTHERNo intervention

Control group with no administration of Tranexamic Acid.


Locations(2)

George Washington University Hospital

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

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

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NCT05370820


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