RecruitingNot Applicable

Medicines in Breast Milk and Estimated Infant Exposure

Denmark250 participantsStarted 2024-12-20

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Drug concentrations in human milk

Timeframe: Within one dosing interval

Trial details

NCT IDNCT07346716

SponsorUniversity Hospital Bispebjerg and Frederiksberg

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-01

Contact for this trial

Ditte Resendal Gotfredsen, MD

+4521472051 ditte.resendal.gotfredsen@regionh.dk

View on ClinicalTrials.gov More Breastfeeding trials