RecruitingNCT07346716

Medicines in Breast Milk and Estimated Infant Exposure

Medication Concentrations in Human Milk (MedMilk) and Potential Adverse Effects in Breastfed Infants: an Exploratory Clinical Study

Sponsor

University Hospital Bispebjerg and Frederiksberg

Enrollment

250 participants

Start Date

Dec 20, 2024

Study Type

OBSERVATIONAL

Conditions

Medication Safety Breastfeeding Lactation Drug Exposure Via Breast Milk Pharmacokinetic Parameters

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

Lactating women aged ≥18 years
Current use of one or more prescription or over-the-counter (classified within the ATC system) drugs
Able and willing to provide written informed consent

Exclusion Criteria2

Current pregnancy during sample collection
Known and clinically significant pharmacokinetic drug-drug interactions at the time of sampling

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Interventions

DRUGPrescription 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.