RecruitingPhase 1

Excretion of Rivaroxaban in Human Breast Milk

United States10 participantsStarted 2025-07

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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
✓. Meet inclusion criteria for prophylactic rivaroxaban dose: pre-pregnancy BMI \>/= 40 and/or any personal history of VTE. Or \>/= 2 of the following: pre-pregnancy BMI 30-39, immobility, pregnancy complications, cesarean delivery, hysterectomy
✓. Or meet inclusion criteria for therapeutic rivaroxaban dose: have an indication for therapeutic anticoagulation per the American College of Obstetricians and Gynecologists' (ACOG) practice bulletin #196, or other indication per their primary team, and recommended for such anticoagulation per their primary practitioner.

Exclusion criteria

✕. 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.

What they're measuring

Concentration of rivaroxaban in breast milk

Timeframe: Postpartum day 1

Concentration of rivaroxaban in breast milk

Timeframe: Postpartum week 6

Absolute infant dose of rivaroxaban

Timeframe: 6 week postpartum

Relative infant dose

Timeframe: 6 weeks postpartum

Trial details

NCT IDNCT06831474

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

Contact for this trial

Sophie H Green, MD

215-955-5500 sophie.green@jefferson.edu

View on ClinicalTrials.gov More Postpartum trials