Medicines in Breast Milk and Estimated Infant Exposure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Current pregnancy during sample collection

Known and clinically significant pharmacokinetic drug-drug interactions at the time of sampling

Trial design

Treatments tested in this trial

  • Prescription Drugs

Treatment groups

250 Participants
are divided into 1 treatment group