Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
ID06831474

Excretion of Rivaroxaban in Human Breast Milk Phase 1 Clinical Trial of Prophylactic and Therapeutic Dosing in Postpartum Women

Led by Thomas Jefferson University · Updated on 2025-07-17

10

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a phase 1 clinical trial to study how rivaroxaban, a blood thinner, passes into human breast milk when given in both preventive (prophylactic) and treatment (therapeutic) doses. The study aims to improve existing knowledge about rivaroxaban safety during breastfeeding by including repeated dosing over time and a larger group of postpartum women. This information will help doctors provide better guidance for postpartum care. Participants will receive either 10 mg or 20 mg of rivaroxaban daily, starting from the first day after giving birth. The dose depends on whether the participant meets criteria for prophylactic or therapeutic use, as decided by their healthcare team. Medication is provided through the hospital pharmacy and nursing staff as part of standard care. During the study, researchers will collect breast milk samples on postpartum day 1 and at week 6 to measure rivaroxaban concentration. They will also assess the amount of rivaroxaban the infant might be exposed to. The study involves monitoring participants over six weeks, with safety and dosing assessments throughout. These results aim to inform clinical guidelines regarding rivaroxaban use in breastfeeding mothers.

CONDITIONS

Brief Title

Excretion of Rivaroxaban in Human Breast Milk

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postpartum within 6 weeks of delivery
  • At least 18 years old at expected date of delivery
  • English speaking
  • Hemodynamically stable without ongoing blood loss
  • Non-breastfeeding or breastfeeding an infant born at or after 37 weeks gestation, weighing over 2600 grams, and not requiring intensive care
  • Meet criteria for prophylactic rivaroxaban dose: pre-pregnancy BMI 40 or higher and/or personal history of venous thromboembolism or at least two of the following: pre-pregnancy BMI 30-39, immobility, pregnancy complications, cesarean delivery, hysterectomy
  • Or meet criteria for therapeutic rivaroxaban dose: indication for therapeutic anticoagulation per ACOG guidelines or other indication recommended by primary care team
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • Under 18 years old at estimated date of delivery
  • Hemodynamic instability or ongoing blood loss
  • Newly diagnosed deep vein thrombosis or pulmonary embolism in postpartum period
  • Abnormal kidney or liver function (creatinine clearance below 30 mL/min or liver tests above normal)
  • Contraindication to rivaroxaban such as allergy or active bleeding
  • Breastfeeding an infant admitted to neonatal intensive care unit, or infant born before 37 weeks or weighing less than 2600 grams
  • Age under 40, mobile, BMI under 30, and no active cancer history
  • No indication for therapeutic anticoagulation in postpartum period per ACOG guidelines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 6 weeks postpartum

Participants receive daily oral doses of rivaroxaban starting from the first postpartum day, either 10 mg for prophylactic dosing or 20 mg for therapeutic dosing, as determined by their physician team.

Visits aligned with postpartum care up to 6 weeks

Trial Site Locations

Total: 1 location

1

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

S

Sophie H Green, MD

R

Rupsa C Boelig, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial.

Christoph Male, Anthonie W A Lensing, Joseph S Palumbo...

https://pubmed.ncbi.nlm.nih.gov/31699660

Cost-effectiveness of Apixaban Versus Other Oral Anticoagulants for the Initial Treatment of Venous Thromboembolism and Prevention of Recurrence.

Tereza Lanitis, Robert Leipold, Melissa Hamilton...

https://pubmed.ncbi.nlm.nih.gov/26922297