How medicines you take show up in breast milk and how much your baby might get

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study enrolls breastfeeding women who are already taking prescription or over-the-counter medicines as part of routine care. Participants provide timed small breast milk samples, one urine sample, and answer questions about maternal and infant health and breastfeeding patterns. Samples are stored and later analyzed using UPLC-MS/MS to measure drug concentrations and calculate relative infant doses where data are sufficient. No experimental drugs are given and results will be reported descriptively to add to knowledge about medication transfer into human milk.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Clinical Pharmacology
  Copenhagen, Denmark Recruiting
• Mental health services, Capital Region of Denmark
  Copenhagen, Denmark Recruiting
• Department of Obstetrics and Gynecology, Herlev Hospital
  Herlev, Denmark Recruiting

Study contacts

• Principal investigator: Jon Traerup Andersen, Professor, MD, PhD — Department of Clinical Pharmacology, Bispbjeg and Frederiksberg Hospital
• Study coordinator: Ditte Resendal Gotfredsen, MD
• Email: ditte.resendal.gotfredsen@regionh.dk
• Phone: +4521472051

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.