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

Recruitingn/aAges any - anyAllDuke University
NCT03511118 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Tranexamic acid (TXA)
  • labetalol
  • metformin
  • nifedipine
  • clindamycin
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Where

22 sites
University of California-San Diego Medical Center
La Jolla, United States
Loma Linda University Health
Loma Linda, United States
Northwestern University
Chicago, United States
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, United States
Indiana University Health
Indianapolis, United States
University of Iowa Hospitals and Clinics
Iowa City, United States
Children's Hospital and Clinics - Minneapolis
Minneapolis, United States
University of New Mexico, Health Sciences Center
Albuquerque, United States

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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