RecruitingPhase 1NCT06831474

Excretion of Rivaroxaban in Human Breast Milk

Sponsor

Thomas Jefferson University

Enrollment

10 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

VTE (Venous Thromboembolism)Postpartum Breast Milk Collection Breastfeeding VTE Prophylaxis Rivaroxaban

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

Postpartum within 6 weeks of delivery
Greater than 18 years old at expected date of delivery
English speaking
Hemodynamically stable without concern for ongoing blood loss
Non-breastfeeding
Or breastfeeding an infant born at or equal to 37 weeks' gestation, weighing \>2600g at birth and is not requiring intensive care

Exclusion Criteria9

Pregnant
Less than 18 years old at estimated date of delivery
Hemodynamic instability and/or concern for ongoing blood loss
Newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) in the postpartum period
Abnormal maternal renal or liver function (creatinine clearance \< 30 mL/min and/or liver function tests greater than lab normal)
A contraindication to rivaroxaban: hypersensitivity to rivaroxaban; active pathological bleeding
Breastfeeding an infant admitted to neonatal intensive care unit, infant gestational age at birth \<37w0d or weighing \<2600g.
If all of the following are met: age less than 40, ambulating, body mass index (BMI) less than 30, no active history of malignancy.
If patient lacks indication for therapeutic anticoagulation in the postpartum period per the American College of Obstetricians and Gynecologists' (ACOG) practice bulletin #196

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