Dabigatran and rivaroxaban in breastmilk
Research type
Research Study
Full title
An Open Label, Non-Randomised Phase IV Clinical Study to Determine the Excretion of Dabigatran and Rivaroxaban in Breastmilk Following Oral Administration
IRAS ID
243946
Contact name
Yating Zhao
Contact email
Sponsor organisation
King's College London
Eudract number
2018-003852-19
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
The risk of developing of blood clots in the veins of the body has a relatively increased incidence in women following the birth of a baby. So mothers who are at high risk of getting these clots or already have these clots are given blood thinning medicines for at least 7 days after delivery. Currently, heparin and warfarin are the only safe blood thinning drugs prescribed when women are breastfeeding as they do not pass into breast milk. Many women find them inconvenient, because they are required to inject heparin themselves at home, or attend the clinic frequently for the monitoring of the effects of warfarin.
In recent years, new blood thinning drugs, such as dabigatran and rivaroxaban, have become available in the UK. They can be taken as tablets or capsules and require no monitoring. However, it is not known whether these drugs pass into human breast milk.
The purpose of this study is to investigate whether dabigatran or rivaroxaban pass into human breast milk, which will help to find out if these drugs could be used instead of heparin injections or warfarin for breastfeeding women.
Breastfeeding mothers who are currently breastfeeding and at least 2 weeks following the delivery of their babies will be invited to take part. During the study, participants will be asked to swallow two dabigatran capsules or one rivaroxaban tablet. Home visits will be provided to collect blood and breast milk samples. The samples will be tested in the laboratory to see if the drug is detected in breastmilk.REC name
London - Fulham Research Ethics Committee
REC reference
19/LO/0082
Date of REC Opinion
21 Feb 2019
REC opinion
Further Information Favourable Opinion