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Breastfeeding and meds: new study aims to uncover hidden risks for babies

NCT ID NCT07346716

Knowledge-focused Sponsor: University Hospital Bispebjerg and Frederiksberg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how prescription and over-the-counter medicines taken by breastfeeding mothers get into their breast milk and whether they might affect their babies. Researchers will collect milk and urine samples from 250 women and ask about infant symptoms. The goal is to provide clearer safety information for doctors and mothers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prescription and over-the-counter drugs taken by breastfeeding women as part of routine care
What this could lead to
If successful, this study could provide better data to help doctors and mothers make safer decisions about medication use during breastfeeding.
What could go wrong
This is an early observational study, not a treatment trial. It only measures drug levels and reports symptoms, so it cannot prove cause and effect or change practice directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will be lactating women recruited through obstetric, neonatal, and psychiatric departments, public health visiting nurses, and counselling services across Denmark. Recruitment will be coordinated by the Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, Copenhagen. The study primarily targets women using prescription and over-the-counter medicines during breastfeeding and aims to represent real-world exposure patterns across all Danish regions.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Breast Feeding lactation disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breastfeeding Drug exposure via breast milk Lactation Medication safety Pharmacokinetic parameters

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Clinical Pharmacology

    RECRUITING

    Copenhagen, Denmark

  • Department of Obstetrics and Gynecology, Herlev Hospital

    RECRUITING

    Herlev, Denmark

  • Mental health services, Capital Region of Denmark

    RECRUITING

    Copenhagen, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.