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Medicines in Breast Milk and Estimated Infant Exposure
Sponsor: University Hospital Bispebjerg and Frederiksberg
Summary
The MedMilk (Medication concentrations in human Milk) study investigates how selected medicines taken by breastfeeding women are transferred into human milk and whether this may affect the breastfed child. The study includes breastfeeding women who are already using prescription or over-the-counter medicines as part of their usual care. Participants provide samples of breast milk and urine and complete a questionnaire about maternal and infant health. The collected data will be used to quantify medicine concentrations in milk and estimate the relative infant dose. The study aims to contribute new data to support safer prescribing and more informed counselling during breastfeeding
Official title: Medication Concentrations in Human Milk (MedMilk) and Potential Adverse Effects in Breastfed Infants: an Exploratory Clinical Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2024-12-20
Completion Date
2030-01
Last Updated
2026-01-16
Healthy Volunteers
Yes
Conditions
Interventions
Prescription Drugs
Exposure to prescription medicines taken by breastfeeding women during routine treatment. The study does not assign medications but observes drug transfer into human milk from exposures occurring as part of usual care.
Locations (3)
Department of Clinical Pharmacology
Copenhagen, Denmark
Mental health services, Capital Region of Denmark
Copenhagen, Denmark
Department of Obstetrics and Gynecology, Herlev Hospital
Herlev, Denmark