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Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Sponsor: Duke University
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1600
Start Date
2018-10-04
Completion Date
2027-07-31
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
Tranexamic acid (TXA)
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
labetalol
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
metformin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
nifedipine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
clindamycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
oxycodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
azithromycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
escitalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
sertraline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
ondansetron
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Ciprofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Doxycycline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Levofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Methylphenidate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Sumatriptan
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Citalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Cyclobenzaprine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Furosemide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Gabapentin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Hydrochlorothiazide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Hydroxyurea
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Rosuvastatin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Topiramate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Trazodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Valganciclovir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Venlafaxine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Verapamil
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Remdesivir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Anakinra
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Tocilizumab
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Fluvoxamine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Amoxicillin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Bupropion
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Duloxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Hydrocodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Levetiracetam
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Paroxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Buprenorphine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Locations (22)
University of California-San Diego Medical Center
La Jolla, California, United States
Loma Linda University Health
Loma Linda, California, United States
Northwestern University
Chicago, Illinois, United States
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Children's Hospital and Clinics - Minneapolis
Minneapolis, Minnesota, United States
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Duke University Maternal and Fetal Medicine
Durham, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Texas Tech University Health Sciences Center School of Medicine.
Amarillo, Texas, United States
University of Texas Medical Branch - Galveston
Galveston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
The Women's Hospital of Texas
Houston, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Lawson Health Research Institute
London, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada