What is rivaroxaban studying for breastfeeding mothers?

This trial is studying how rivaroxaban passes into breast milk at preventive and treatment doses in postpartum women. Researchers want to understand the safety of rivaroxaban during breastfeeding to help healthcare providers give better advice. The study is sponsored by Thomas Jefferson University.

Who may be eligible for this postpartum clinical trial?

Women aged 18 years or older who are within 6 weeks postpartum and either breastfeeding an infant born at or after 37 weeks weighing more than 2600 grams or not breastfeeding. Participants should be stable without ongoing blood loss and meet criteria for rivaroxaban dosing recommended by their doctor. Please review eligibility criteria for more details.

Is there any cost to participate in this postpartum clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years +

FEMALE

ID06831474

Study of Rivaroxaban Use and Its Presence in Breast Milk for Postpartum Women Comparing Preventive and Therapeutic Doses Over Time

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

Participants Needed

Research Sites

17 weeks

Total Duration

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Prophylactic (Low Dose) Rivaroxaban	Therapeutic/Intermediate (High Dose) Rivaroxaban
What it is	A preventive daily oral anticoagulant (10 mg rivaroxaban) for postpartum women at increased risk of blood clots.	A daily oral anticoagulant (20 mg rivaroxaban) for postpartum women with clinical need for therapeutic or intermediate dose anticoagulation.
Role in the study	Assessed to determine how much rivaroxaban passes into breast milk when used at a low preventive dose.	Assessed to measure rivaroxaban levels in breast milk after higher, therapeutic dosing in eligible postpartum women.
Main purpose	Used to reduce the risk of blood clots in postpartum women identified as increased risk but without acute clot present.	Used to treat postpartum women requiring full-dose anticoagulation for conditions such as diagnosed venous thromboembolism or high risk per guidelines.
How it is given	Taken as a 10 mg oral tablet once daily starting after delivery as directed by the protocol.	Taken as a 20 mg oral tablet once daily following delivery per specific indication.
Evidence base	Effectiveness for VTE prevention in postpartum women is under clinical investigation; current evidence for breast milk exposure is limited, with a small number of published case reports and transfer studies noting detectable but low levels of rivaroxaban in breast milk.	Therapeutic/intermediate dose rivaroxaban has limited published evidence for safety or effectiveness in breastfeeding postpartum women; available case studies show variable milk concentrations and absence of clinical outcome data.
Important limitations	Small study sizes, limited data on infant safety, and lack of long-term outcomes restrict confident clinical use for breastfeeding mothers.	Scarce evidence in women needing therapeutic/intermediate dosing after childbirth, high uncertainty about infant risk, and lack of long-term infant health tracking.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

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

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

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