Thomas Jefferson University
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.
The aim of our study is to perform a phase 1, single arm clinical trial to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic maternal doses. Our goal is to enhance the limited, although positive, data regarding the safety of rivaroxaban in breastfeeding. Our novel contributions to the existing body of literature will be in our investigation of rivaroxaban at both prophylactic and therapeutic doses, in repeated doses over time, and in a larger sample of participants. These results will provide physicians and national societies with safety data need…
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, hysterec…
10mg rivaroxaban daily
20mg rivaroxaban daily
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