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Studying how common drugs affect breastfeeding women and their infants

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

Observational Duke University · NCT03511118

This study looks at how common medications affect breastfeeding women and their babies to see how much of these drugs might pass into breastmilk.

Quick facts

Study typeObservational
Enrollment1600 (estimated)
SexAll
SponsorDuke University Academic / other
Locations22 sites (La Jolla, California and 21 other locations)
Trial IDNCT03511118 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the pharmacokinetics and safety of commonly prescribed drugs in lactating women and their breastfed infants. It focuses on measuring the concentration of these drugs in breastmilk and estimating the amount that infants may consume through breastfeeding. Participants will provide breastmilk and blood samples, along with blood samples from their infants, to assess the transfer of these medications. The findings will contribute to a better understanding of the implications of drug use during breastfeeding and inform future research.

Who should consider this trial

Good fit: Ideal candidates include lactating women who are taking at least one of the selected drugs and their infants who are receiving maternal breastmilk.

Not a fit: Patients who are not currently breastfeeding or those whose infants are older than 180 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide crucial information on the safety of medications for breastfeeding mothers and their infants.

How similar studies have performed: While studies on drug transfer in breastfeeding have been conducted, this specific investigation into the pharmacokinetics of commonly used drugs in lactating women is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

La Jolla, California and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lactating Women on Select DOIBreastfed Infants of Mothers on Select DOI
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.