Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT06831474

Excretion of Rivaroxaban in Human Breast Milk

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

10

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.

CONDITIONS

Official 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
  • Age greater than 18 years 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 2600g at birth and not requiring intensive care
  • Meet criteria for prophylactic rivaroxaban dose: pre-pregnancy BMI 40 or higher and/or personal history of VTE, or at least two of the following: pre-pregnancy BMI 30-39, immobility, pregnancy complications, cesarean delivery, hysterectomy
  • Meet criteria for therapeutic rivaroxaban dose: indication for therapeutic anticoagulation per ACOG practice bulletin #196 or other indication recommended by primary practitioner
Not Eligible

You will not qualify if you...

  • Pregnant
  • Less than 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 maternal kidney or liver function (creatinine clearance less than 30 mL/min or abnormal liver tests)
  • Contraindication to rivaroxaban such as hypersensitivity or active pathological bleeding
  • Breastfeeding an infant admitted to neonatal intensive care unit or infant born before 37 weeks gestation or weighing less than 2600g
  • Age under 40, ambulating, BMI less than 30, and no active history of malignancy
  • Lack of indication for therapeutic anticoagulation per ACOG practice bulletin #196

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

R

Rupsa C Boelig, MD

CONTACT

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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