NCT07346716 Medicines in Breast Milk and Estimated Infant Exposure
| NCT ID | NCT07346716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Bispebjerg and Frederiksberg |
| Condition | Breastfeeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2028-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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