Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Duke University
1,600 participants
Oct 4, 2018
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- 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 Criteria2
- 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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Interventions
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Locations(22)
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NCT03511118