Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Recruiting
Observational Study
Lactating Women on Select DOI
Breastfed Infants of Mothers on Select DOI
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,600 (estimated)
- Sponsor
- Duke University · Other
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About This Trial
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 am…
Trial Locations
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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. L…
Contacts