Status:
RECRUITING
UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Innovative Medicines Initiative
BELpREG
Conditions:
Breast Feeding
Human Milk
Eligibility:
FEMALE
18+ years
Brief Summary
The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake. The main questions it aims to answer are: * What is the concentratio...
Detailed Description
There is an immense information gap regarding safety of medicines during lactation which can result in a lack of breastfeeding adherence. According to literature, 50% of women need pharmacotherapy in ...
Eligibility Criteria
Inclusion
- For breastfeeding women
- Maternal age: ≥ 18 year
- Currently exclusively or partially breastfeeding (/expressing milk) at the time of milk sampling
- Using medicines for any indication, with at least 5 half-lives of the medicine taken
- Willing to express and collect human milk
- Signed informed consent to participate and for processing their personal data
- For infants
- Gestational age at birth: ≥24 weeks
- Parental signed informed consent to participate and for processing their personal data
Exclusion
- Maternal age \<18 years
- Mother of twins
- Not meeting the inclusion criteria
Key Trial Info
Start Date :
February 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06042803
Start Date
February 1 2023
End Date
February 1 2027
Last Update
February 27 2025
Active Locations (1)
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1
Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000