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Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Who can join
All ages · All sexes
Full eligibility 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.
About the study
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.
What is being tested
- Tranexamic acid (TXA) (drug)
- labetalol (drug)
- metformin (drug)
- nifedipine (drug)
- clindamycin (drug)
- oxycodone (drug)
Sponsor: Duke University · Participants: 1,600 · Started: Oct 4, 2018
Contact the study team
- Allyn Damman · Phone: 919-259-4414
- Cheryl Alderman · Phone: 919-966-8349
Official record on ClinicalTrials.gov — NCT03511118
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.