Postpartum, VTE Prophylaxis, VTE (Venous Thromboembolism), Rivaroxaban, Breastfeeding, Breast Milk Collection
Conditions
Keywords
Rivaroxaban, Relative infant dose, LACT, Rivaroxaban in breast milk
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.
Detailed description
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.
Interventions
10mg rivaroxaban daily
20mg rivaroxaban daily
Sponsors
Thomas Jefferson University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a prospective phase 1, two arm drug trial comparing the excretion of rivaroxaban in human breast milk between groups receiving prophylactic or therapeutic dosing during the postpartum period. Patients will be screened and enrolled for participation either antepartum or postpartum. Once postpartum, patients will be re-screened for any exclusion criteria and to be sure all inclusion criteria is met. Prior to receiving rivaroxaban each patient will provide a baseline 1 mL breast milk sample. Patients will either receive 10 mg or 20 mg daily of rivaroxaban starting by the first postpartum day. The dose will be be ordered by their postpartum physician team through the inpatient pharmacy and dispensed by their inpatient nursing team, as per standard of care at the discretion of their physician. 1 mL of breast milk will be collected at 3, 6, 12, 15 and 24 hours following their first morning dose. The patient will continue the medication while in house and for each subsequent day o
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of rivaroxaban in breast milk | Postpartum 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 |
| Absolute infant dose of rivaroxaban | 6 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 dose | 6 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. |
Countries
United States
Contacts
Primary ContactSophie H Green, MD
Backup ContactRupsa C Boelig, MD
Outcome results
None listed