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New treatment option for Postpartum
Official title Excretion of Rivaroxaban in Human Breast Milk
ClinicalTrials.gov ID: NCT06831474
What this study is testing
What is Rivaroxaban 10 MG Oral Tablet?
Rivaroxaban 10 MG Oral Tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for postpartum.
Also referred to as Xarelto.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Postpartum within 6 weeks of delivery
- Greater than 18 years old at expected date of delivery
- English speaking
- Hemodynamically stable without concern for ongoing blood loss
- Non-breastfeeding
You likely can't join if
- Pregnant
- Less than 18 years old at estimated date of delivery
- Hemodynamic instability and/or concern for ongoing blood loss
- Newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) in the postpartum period
- Abnormal maternal renal or liver function (creatinine clearance \< 30 mL/min and/or liver function tests greater than lab normal)
- A contraindication to rivaroxaban: hypersensitivity to rivaroxaban; active pathological bleeding
See the full eligibility criteria
- Postpartum within 6 weeks of delivery
- Greater than 18 years old at expected date of delivery
- English speaking
- Hemodynamically stable without concern for ongoing blood loss
- Non-breastfeeding
- Or breastfeeding an infant born at or equal to 37 weeks' gestation, weighing \>2600g at birth and is not requiring intensive care
- Meet 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...
- Or meet 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...
- Pregnant
- Less than 18 years old at estimated date of delivery
- Hemodynamic instability and/or concern for ongoing blood loss
- Newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) in the postpartum period
- Abnormal maternal renal or liver function (creatinine clearance \< 30 mL/min and/or liver function tests greater than lab normal)
- A contraindication to rivaroxaban: hypersensitivity to rivaroxaban; active pathological bleeding
- Breastfeeding an infant admitted to neonatal intensive care unit, infant gestational age at birth \<37w0d or weighing \<2600g.
- If all of the following are met: age less than 40, ambulating, body mass index (BMI) less than 30, no active history of malignancy.
- If patient lacks indication for therapeutic anticoagulation in the postpartum period per the American College of Obstetricians and Gynecologists' (ACOG) practice bulletin #196
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.