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RECRUITING
NCT03511118

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

Sponsor: Duke University

View on ClinicalTrials.gov

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

DRUG

Tranexamic acid (TXA)

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

labetalol

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

metformin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

nifedipine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

clindamycin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

oxycodone

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

azithromycin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

escitalopram

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

sertraline

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

ondansetron

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Ciprofloxacin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Doxycycline

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Levofloxacin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Methylphenidate

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Sumatriptan

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Citalopram

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Cyclobenzaprine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Furosemide

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Gabapentin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Hydrochlorothiazide

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Hydroxyurea

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Rosuvastatin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Topiramate

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Trazodone

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Valganciclovir

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Venlafaxine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Verapamil

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Remdesivir

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Anakinra

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Tocilizumab

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Fluvoxamine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Amoxicillin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Bupropion

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Duloxetine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Hydrocodone

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Levetiracetam

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Paroxetine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

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