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Understanding Medications in Breast Milk: Tranexamic acid, Labetalol, Metformin, Nifedipine, and Clindamycin

This study is looking at how much of certain commonly used medications, like tranexamic acid, labetalol, metformin, nifedipine, and clindamycin, pass into breast milk and how much of these drugs breastfed infants might receive. The goal is to learn more about these drugs when taken by breastfeeding mothers and their potential effects on infants. You can join if you are a breastfeeding mother taking one of these medications as part of your regular medical care, and your baby is 180 days old or younger. The study aims to understand the drug levels in mothers' blood and breast milk, and in infants' blood. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving you a new treatment. It plans to include up to 1600 participants.
What's involved
You would provide breast milk and blood samples, and your infant would provide blood samples. These collections would continue until your infant is 180 days old.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until the infant becomes 180 days of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03511118

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting
Not specifiedAll AgesObservational
Duke University
~1,600 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Tranexamic acid (TXA)labetalolmetforminnifedipineclindamycinoxycodone

At a glance

Recruiting sites
13 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
M/P ratio
Measured over Until the infant becomes 180 days of age
+3 more outcomes measured

Conditions

Lactating Women on Select DOI
Breastfed Infants of Mothers on Select DOI

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InfantWeaning

Where it's being run

22 sites across 14 states
Texas5
California2
Illinois2
North Carolina2
Pennsylvania2
Indiana1
Iowa1
Minnesota1

Study leadership

  • Samia Aleem, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Allyn Damman
[email protected]
919-259-4414
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.

Exclusion

Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study.
Known pregnancy during PK sampling.

What this trial measures

  • M/P ratioUntil the infant becomes 180 days of age

    Characterize the pharmacokinetics using maternal milk/plasma exposure ratio is calculated by dividing the BMS01 drug of interest breastmilk concentration by the BMS01 drug of interest in maternal plasma concentration.

  • DIDUntil the infant becomes 180 days of age

    Pharmacokinetics is characterized by estimated daily infant dose-daily infant dose which estimates the quantity of drug delivered to an infant via breastmilk in a given day.

  • RIDUntil the infant becomes 180 days of age

    Pharmacokinetics is characterized by relative infant dose is a method of relating the potential dose of the drug delivered to the infant to the typical therapeutic dose given to the mother.

  • I/M ratioUntil the infant becomes 180 days of age

    Pharmacokinetics is characterized using infant maternal/exposure ratio. IM ratio is calculated using the average infant plasma concentration of the BMS01 drug of interest and historical value of clearance in infants.