NCT03511118View on ClinicalTrials.gov

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

RecruitingOBSERVATIONAL
Enrollment

1,600

Participants

Timeline

Start Date

October 4, 2018

Primary Completion Date

July 23, 2026

Study Completion Date

July 31, 2027

Conditions
Lactating Women on Select DOIBreastfed Infants of Mothers on Select DOI
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.

Trial Locations (22)

15213

RECRUITING

University of Pittsburgh School of Medicine, Pittsburgh

19104

COMPLETED

Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine, Philadelphia

27599

COMPLETED

University of North Carolina Hospital, Chapel Hill

27705

RECRUITING

Duke University Maternal and Fetal Medicine, Durham

46202

COMPLETED

Indiana University Health, Indianapolis

52242

RECRUITING

University of Iowa Hospitals and Clinics, Iowa City

55404

RECRUITING

Children's Hospital and Clinics - Minneapolis, Minneapolis

60611

COMPLETED

Northwestern University, Chicago

60614

RECRUITING

Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago

77030

RECRUITING

University of Texas Health Science Center at Houston, Houston

77054

NOT_YET_RECRUITING

The Women's Hospital of Texas, Houston

77555

RECRUITING

University of Texas Medical Branch - Galveston, Galveston

78229

NOT_YET_RECRUITING

University of Texas Health Science Center, San Antonio

79106

RECRUITING

Texas Tech University Health Sciences Center School of Medicine., Amarillo

84132

RECRUITING

University of Utah, Salt Lake City

87131

COMPLETED

University of New Mexico, Health Sciences Center, Albuquerque

92093

RECRUITING

University of California-San Diego Medical Center, La Jolla

92354

RECRUITING

Loma Linda University Health, Loma Linda

97239

RECRUITING

Oregon Health & Science University, Portland

98195-7630

COMPLETED

University of Washington, Seattle

N6A 5W9

COMPLETED

Lawson Health Research Institute, London

H3T IC5

COMPLETED

Centre Hospitalier Universitaire Sainte-Justine, Montreal

Sponsors

Lead Sponsor

Duke University
All Listed Sponsors
collaborator

The Emmes Company, LLC

INDUSTRY

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Duke University

OTHER