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 needed to properly counsel patients and advance clinical guidelines for postpartum care.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
10
10mg rivaroxaban daily
20mg rivaroxaban daily
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGConcentration of rivaroxaban in breast milk
Time/Concentration profile of rivaroxaban in breast milk prior to intake (0) and 3, 6, 12, 15 and 24 hours following morning dose on day 0-1
Time frame: Postpartum day 1
Concentration of rivaroxaban in breast milk
Time/concentration profile of rivaroxaban in breast milk 3 hours following morning dose on day 2 and onward
Time frame: Postpartum week 6
Absolute infant dose of rivaroxaban
The absolute infant dose is calculated from average drug concentrations in breast milk multiplied by an estimated breast milk intake of 150 mL/kg/day.
Time frame: 6 week postpartum
Relative infant dose
The relative infant dose is the absolute infant dose expressed as a percentage of the weight adjusted maternal dose, based on an average maternal weight of 75 kg. It is expressed in mg/kg/day.
Time frame: 6 weeks postpartum
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