Recruiting
Phase 1

Rivaroxaban

Sponsor:

Thomas Jefferson University

Code:

NCT06831474

Conditions

Postpartum

VTE Prophylaxis

VTE (Venous Thromboembolism)

Rivaroxaban

Breastfeeding

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rivaroxaban 10 MG Oral Tablet

Rivaroxaban 20 MG Oral Tablet

Study Details

Brief 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.

Conditions

Postpartum

VTE Prophylaxis

VTE (Venous Thromboembolism)

Rivaroxaban

Breastfeeding

Study ID

NCT06831474

Start date

Jul, 2025

Status verified date

Jul, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Postpartum within 6 weeks of delivery
2. Greater than 18 years old at expected date of delivery
3. English speaking
4. Hemodynamically stable without concern for ongoing blood loss
5. Non-breastfeeding
6. Or breastfeeding an infant born at or equal to 37 weeks' gestation, weighing >2600g at birth and is not requiring intensive care
7. 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
8. 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:

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Prophylactic rivaroxaban

Patients will receive 10 mg daily of rivaroxaban starting by the first postpartum day. The medication will be ordered by their postpartum physician team through the inpatient pharmacy and dispensed by their inpatient nursing team, as per standard of care. The decision for dose 10 mg vs 20 mg of rivaroxaban is based on inclusion criteria and patient's physician team's recommendation for prophylactic (10 mg) vs. therapeutic (20 mg) dosing.

active comparator: Therapeutic or Intermediate dose rivaroxaban

Patients will receive 20 mg daily of rivaroxaban starting by the first postpartum day. The medication will be ordered by their postpartum physician team through the inpatient pharmacy and dispensed by their inpatient nursing team, as per standard of care. The decision for 10 mg vs 20 mg of rivaroxaban is based on inclusion criteria and patient's physician team's recommendation for prophylactic (10 mg) vs. therapeutic (20 mg) dosing.

Interventions

Rivaroxaban 10 MG Oral Tablet

10mg rivaroxaban daily

Rivaroxaban 20 MG Oral Tablet

20mg rivaroxaban daily

Primary outcome measure

  • Concentration of rivaroxaban in breast milk [ Time Frame: Postpartum day 1 ]
  • Concentration of rivaroxaban in breast milk [ Time Frame: Postpartum week 6 ]
  • Absolute infant dose of rivaroxaban [ Time Frame: 6 week postpartum ]
  • Relative infant dose [ Time Frame: 6 weeks postpartum ]

Central Contacts and Locations

Central contacts

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Principal Investigator:

Rupsa C Boelig, MD

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Keywords

  • Rivaroxaban
  • Relative infant dose
  • LACT
  • Rivaroxaban in breast milk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-07-17.