Breastfeeding, Drug Exposure Via Breast Milk, Lactation, Medication Safety, Pharmacokinetic Parameters
Conditions
Keywords
breastfeeding, lactation, drug transfer into breast milk, medication safety
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
Detailed description
The MedMilk (Medication concentrations in human Milk) study is a prospective, exploratory clinical study coordinated by the Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, Denmark. The study is observational in nature and involves no experimental drug administration. Participants are breastfeeding women using medicines as part of their routine treatment. Each participant will provide four small breast milk samples (1-20 mL each) collected at different time points in relation to maternal drug intake, one urine sample, and questionnaire data on maternal and infant health, breastfeeding patterns, and any infant symptoms potentially related to drug exposure. Samples are stored at -80 °C in a dedicated research biobank until analysis. Drug concentrations in milk and urine will primarily be quantified using solid Phase Extraction coupled with UPLC-MS/MS. Data will be analyzed descriptively, and relative infant doses (RID) will be calculated. For drugs with sufficient sampling density. Results will add to the limited body of systematic data on drug transfer into human milk and help inform clinical decision-making regarding medication use during breastfeeding.
Interventions
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.
Sponsors
University Hospital Bispebjerg and Frederiksberg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug concentrations in human milk | Within one dosing interval | Quantification of drug concentrations in human milk, expressed in micrograms per millilitre (µg/mL). Milk samples are collected before and after the maternal dose within one dosing interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Infant Dose (RID) | Within one dosing interval | Estimation of infant drug exposure, expressed as the relative infant dose (% of maternal weight-adjusted dose). |
| Maternal-reported infant adverse effects | At the time of inclusion. Montly follow-up for three months. | Maternal questionnaire on infant symptoms potentially related to drug exposure via breastfeeding. |
Countries
Denmark
Contacts
CONTACTDitte Resendal Gotfredsen, MD
CONTACTJon Traerup Andersen, Professor, MD, PhD
PRINCIPAL_INVESTIGATORJon Traerup Andersen, Professor, MD, PhD
Department of Clinical Pharmacology, Bispbjeg and Frederiksberg Hospital
Outcome results
None listed