Actively Recruiting
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Led by Duke University · Updated on 2026-04-24
1600
Participants Needed
22
Research Sites
512 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
T
The Emmes Company, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lactating women who are 180 days postpartum or less and are receiving at least one drug of interest as part of standard care
- Infants who are 180 days old or younger and receive breastmilk from their mother
- Informed consent and HIPAA authorization obtained according to local guidelines
- Lactating women who are not legal adults and their infants may participate if assent and guardian consent are obtained per local rules
You will not qualify if you...
- Any medical condition that would prevent participation as determined by the patient's physician or the study's principal investigator
- Known pregnancy during pharmacokinetic sampling
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
University of California-San Diego Medical Center
La Jolla, California, United States, 92093
Actively Recruiting
2
Loma Linda University Health
Loma Linda, California, United States, 92354
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Completed
4
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60614
Actively Recruiting
5
Indiana University Health
Indianapolis, Indiana, United States, 46202
Completed
6
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
7
Children's Hospital and Clinics - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
8
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Completed
9
University of North Carolina Hospital
Chapel Hill, North Carolina, United States, 27599
Completed
10
Duke University Maternal and Fetal Medicine
Durham, North Carolina, United States, 27705
Actively Recruiting
11
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
12
Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine
Philadelphia, Pennsylvania, United States, 19104
Completed
13
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
14
Texas Tech University Health Sciences Center School of Medicine.
Amarillo, Texas, United States, 79106
Actively Recruiting
15
University of Texas Medical Branch - Galveston
Galveston, Texas, United States, 77555
Actively Recruiting
16
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
17
The Women's Hospital of Texas
Houston, Texas, United States, 77054
Actively Recruiting
18
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Actively Recruiting
19
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
20
University of Washington
Seattle, Washington, United States, 98195-7630
Completed
21
Lawson Health Research Institute
London, Ontario, Canada, N6A 5W9
Completed
22
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T IC5
Completed
Research Team
E
Emily Forgey
CONTACT
C
Cheryl Alderman
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
38
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