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

Description

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.

Conditions

Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Lactating Women on Select DOI
Intervention / Treatment

-

Contacts and Locations

La Jolla

University of California-San Diego Medical Center, La Jolla, California, United States, 92093

Loma Linda

Loma Linda University Health, Loma Linda, California, United States, 92354

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Chicago

Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States, 60614

Indianapolis

Indiana University Health, Indianapolis, Indiana, United States, 46202

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

Minneapolis

Children's Hospital and Clinics - Minneapolis, Minneapolis, Minnesota, United States, 55404

Albuquerque

University of New Mexico, Health Sciences Center, Albuquerque, New Mexico, United States, 87131

Chapel Hill

University of North Carolina Hospital, Chapel Hill, North Carolina, United States, 27599

Durham

Duke University Maternal and Fetal Medicine, Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Kanecia Zimmerman, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2026-07-31