Excretion of Rivaroxaban in Human Breast Milk

Recruiting now · Phase 1

Conditions studied: Postpartum, VTE Prophylaxis, VTE (Venous Thromboembolism), Rivaroxaban, Breastfeeding, Breast Milk Collection

In brief

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.

Key facts

Study ID

NCT06831474

Run by

Thomas Jefferson University

People needed

10

Starts

2025-07-01

Expected to finish

2026-07-31

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.