Multicenter Observational Study Evaluating Safety of Rivaroxaban for Breastfeeding Women

Multicenter Observational Study Evaluating Safety of Rivaroxaban for Breastfeeding Women - SAFE MILK Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056315

Enrollment

Registered

2024-12-31

Start date

2025-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

venous thromboembolism, pulmonary embolism, deep vein thrombosis, puerperal women

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Postpartum breastfeeding women undergoing anticoagulant therapy with rivaroxaban to treat and prevent recurrence of VTE* Newborns born to the above patients* Patients who have given consent to participate in this study (for newborns, consent has been given by a legal representative)

Exclusion criteria

Exclusion criteria: Cases where rivaroxaban is contraindicated Cases where the attending physician deems it inappropriate

Design outcomes

Primary

Measure	Time frame
Rivaroxaban transfer to breast milk	—

Countries

Japan

Contacts

Public ContactYugo Yamashita

Graduate School of Medicine, Kyoto University Department of Cardiovascular Medicine

yyamashi@kuhp.kyoto-u.ac.jp075-751-4255

Outcome results