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Completed

NCT Number: NCT03287336

Prevention of Postpartum Hemorrhage With Tranexamic Acid

Postpartum hemorrhage is a significant contributor to maternal morbidity and mortality and is worldwide. TXA has recently been proven to reduce mortality when given to women in setting of diagnosed PPH. US obstetricians and anesthesiologists are hesitant to use TXA in the peripartum period especially for prevention of PPH due to uncertainty of an optimal dose and safety profile. The purpose of this study is to characterize the pharmacokinetics of TXA when given prophylactically at time of delivery. In addition investigators will determine the pharmacodynamics of TXA in the peripartum period.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

James Slota

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

About this study

Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of the drug will be administered in an escalating fashion by cohort with the lowest dose first. A maximum of 1 gram will be administered. TXA serum levels at several time points after delivery will be assayed. A PK model will be constructed for determining the optimal TXA dose administered at parturition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who are undergoing medically indicated cesarean section at greater than 34+0 weeks gestation or women undergoing elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists
  • Pregnant women with normal serum creatinine (serum creatinine < 0.9)
  • Women between the ages of 18 and 50 years old

Exclusion criteria

  • Patients younger than 18 or older than 50
  • women with active thrombotic or thromboembolic disease
  • Women with a history of arterial or venous thromboembolic event
  • Women with inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome)
  • Women with a subarachnoid hemorrhage
  • Women with acquired defective color vision
  • history of seizure disorder
  • known renal dysfunction
  • multiple gestations (Twin or triplet pregnancies)
  • Hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
  • History of liver dysfunction

Treatment and study plan

Tranexamic Acid

Drug

Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.

Other names: TXA; Cyklokapron

Primary outcomes

  1. PK Model Parameter Estimates

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

    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).

  2. Pharmacodynamics of Tranexamic Acid

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

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

Secondary outcomes

  1. Estimated Blood Loss

    Time frame: During surgery

    Intraoperative blood loss

  2. Safety Parameters

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

    Safety parameters such as adverse events (including nausea/vomiting) and serious adverse events

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Prevention of Postpartum Hemorrhage: Identifying Pregnant Women at Risk and Determining the Safe and Effective Use of Tranexamic Acid Using State-of-the-art Pharmacokinetic/Pharmacodynamics Modeling

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2017
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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