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

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Prescription Drugs for people with breastfeeding, drug exposure via breast milk, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


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

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NCT07346716


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