Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Conditions:
Lactating Women on Select DOI
Breastfed Infants of Mothers on Select DOI
Sponsor: Duke University
trial.available_in:
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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.
Description
The purpose of this study is to understand if the study drugs of interest are found in breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants and what effect this may have on infants; and to share what we learn with other researchers. The study drugs of interest have Food and Drug Administration (FDA) approval, but there is little or no information about the amount of drug found in the breastmilk of mothers who take them; the amount of drug that may be transferred to their infant's through breastmilk; or the effects this transfer may have on their infants. During this study we will ask to collect breastmilk and blood from mothers, and blood from infants, to measure the amount of study drug of interest in these body fluids. Results from this study will help researchers better understand how much of the study drug of interest is in your blood and breastmilk, and how much of the study drug of interest may be in your infant's blood because of breastfeeding.
Who can participate
Inclusion 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.
Exclusion Criteria:
* 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.
Interventions
Tranexamic acid (TXA)
DRUG
labetalol
DRUG
metformin
DRUG
nifedipine
DRUG
clindamycin
DRUG
oxycodone
DRUG
azithromycin
DRUG
escitalopram
DRUG
sertraline
DRUG
ondansetron
DRUG
Ciprofloxacin
DRUG
Doxycycline
DRUG
Levofloxacin
DRUG
Methylphenidate
DRUG
Sumatriptan
DRUG
Citalopram
DRUG
Cyclobenzaprine
DRUG
Furosemide
DRUG
Gabapentin
DRUG
Hydrochlorothiazide
DRUG
Hydroxyurea
DRUG
Rosuvastatin
DRUG
Topiramate
DRUG
Trazodone
DRUG
Valganciclovir
DRUG
Venlafaxine
DRUG
Verapamil
DRUG
Remdesivir
DRUG
Anakinra
DRUG
Tocilizumab
DRUG
Fluvoxamine
DRUG
Amoxicillin
DRUG
Bupropion
DRUG
Duloxetine
DRUG
Hydrocodone
DRUG
Levetiracetam
DRUG
Paroxetine
DRUG
Buprenorphine
DRUG
Locations
22
Canada (2)
Lawson Health Research Institute
London , Ontario
COMPLETED
Centre Hospitalier Universitaire Sainte-Justine
Montreal , Quebec
COMPLETED
United States (20)
University of New Mexico, Health Sciences Center
Albuquerque , New Mexico
COMPLETED
Texas Tech University Health Sciences Center School of Medicine.
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