Rivaroxaban in Breast Milk Study for Postpartum Women
This study is looking at how much rivaroxaban, a blood thinner, gets into breast milk when taken by new mothers. Researchers want to see the levels of rivaroxaban in breast milk at different doses (10mg or 20mg daily) and over time. You may be able to join if you are a woman over 18, within six weeks postpartum, speak English, are medically stable, and are either not breastfeeding or breastfeeding a healthy infant born at 37 weeks or more, weighing over 2600g. The goal is to provide doctors with more information to help guide care for breastfeeding mothers. This study plans to enroll 10 participants.
- Study design
- This is a single-arm study, meaning all participants will receive the study drug. It will involve 10 participants.
- What's involved
- You would take either 10mg or 20mg of rivaroxaban daily. Breast milk will be collected to measure rivaroxaban levels at postpartum day 1 and week 6.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your infant's dose of rivaroxaban will be measured up to 6 weeks postpartum.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Excretion of Rivaroxaban in Human Breast Milk
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Concentration of rivaroxaban in breast milkPostpartum day 1
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
- Concentration of rivaroxaban in breast milkPostpartum week 6
Time/concentration profile of rivaroxaban in breast milk 3 hours following morning dose on day 2 and onward
- Absolute infant dose of rivaroxaban6 week postpartum
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.
- Relative infant dose6 weeks postpartum
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.