Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
250 participants
OBSERVATIONAL
2024-12-20
2030-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Medications in Breast Milk: A Convenience Pharmacokinetic Study
NCT05099484
Drug Concentrations in Breast Milk and Prediction of Blood Levels of the Breastfed Infants
NCT05543122
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
NCT03511118
UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk
NCT06042803
Breastfeeding Advices on OTC Medicines With the Internet: What is the Best Medium
NCT06863597
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Breastfeeding women on medication
Prescription 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prescription 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Known and clinically significant pharmacokinetic drug-drug interactions at the time of sampling
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Bispebjerg and Frederiksberg
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jón Þór Trærup Andersen
Professor, PhD,
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jon Traerup Andersen, Professor, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Pharmacology, Bispbjeg and Frederiksberg Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Clinical Pharmacology
Copenhagen, , Denmark
Mental health services, Capital Region of Denmark
Copenhagen, , Denmark
Department of Obstetrics and Gynecology, Herlev Hospital
Herlev, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-23062687
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.