What this study is
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.
What's being tested
- Tranexamic acid (TXA)
Intervention · DRUG
- labetalol
Intervention · DRUG
- metformin
Intervention · DRUG
- nifedipine
Intervention · DRUG
- clindamycin
Intervention · DRUG
- oxycodone
Intervention · DRUG
- azithromycin
Intervention · DRUG
- escitalopram
Intervention · DRUG
- sertraline
Intervention · DRUG
- ondansetron
Intervention · DRUG
- Ciprofloxacin
Intervention · DRUG
- Doxycycline
Intervention · DRUG
- Levofloxacin
Intervention · DRUG
- Methylphenidate
Intervention · DRUG
- Sumatriptan
Intervention · DRUG
- Citalopram
Intervention · DRUG
- Cyclobenzaprine
Intervention · DRUG
- Furosemide
Intervention · DRUG
- Gabapentin
Intervention · DRUG
- Hydrochlorothiazide
Intervention · DRUG
- Hydroxyurea
Intervention · DRUG
- Rosuvastatin
Intervention · DRUG
- Topiramate
Intervention · DRUG
- Trazodone
Intervention · DRUG
- Valganciclovir
Intervention · DRUG
- Venlafaxine
Intervention · DRUG
- Verapamil
Intervention · DRUG
- Remdesivir
Intervention · DRUG
- Anakinra
Intervention · DRUG
- Tocilizumab
Intervention · DRUG
- Fluvoxamine
Intervention · DRUG
- Amoxicillin
Intervention · DRUG
- Bupropion
Intervention · DRUG
- Duloxetine
Intervention · DRUG
- Hydrocodone
Intervention · DRUG
- Levetiracetam
Intervention · DRUG
- Paroxetine
Intervention · DRUG
- Buprenorphine
Intervention · DRUG
All interventions
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Study details
- Sponsor
- Duke University
- Conditions
- Lactating Women on Select DOI · Breastfed Infants of Mothers on Select DOI
- Enrolling
- 1,600 people
- Starts
- 2018-10-04
- Est. completion
- 2028-07-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (22)
13 openUniversity of California-San Diego Medical Center
La Jolla, California, United States
- Kerri Bertrand · Contact858-246-1713kdutcher@ucsd.edu
- Gretchen Bandoli · Contact858-246-1733gbandoli@ucsd.edu
- Christina Chambers, PhD · Principal investigator
- Michelle Leff · Sub-investigator
RecruitingLoma Linda University Health
Loma Linda, California, United States
- Jose Navarro · Contact909-558-5830jdnavarro@llu.edu
- Stephanie Wells · Contact909-558-5830scwells@llu.edu
- Adrian Lavery · Sub-investigator
- Larry Ngo · Principal investigator
RecruitingAnn and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
- Laura Fearn · Contact312-227-6280lfearn@luriechildrens.org
- Mayra Gomez · Contact312-227-8274mmgomez@luriechildrens.org
- William Muller, MD · Principal investigator
RecruitingChildren's Hospital and Clinics - Minneapolis
Minneapolis, Minnesota, United States
- Quast Emily · Contact612-813-6864emily.quast@childrensmn.org
- Molly fisher · Contact612-813-6864molly.fisher@childrensmn.org
- Andrea Lampland, MD · Principal investigator
RecruitingDuke University Maternal and Fetal Medicine
Durham, North Carolina, United States
- Thelma Fitzgerald · Contact919-684-1224thelma.fitzgerald@duke.edu
- Jordynn Akins · Contact919-681-0013jordynn.akins@duke.edu
- Brenna Hughes, MD · Principal investigator
RecruitingOregon Health & Science University
Portland, Oregon, United States
- Monica Rincon · Contact503-494-8748rincon@ohsu.edu
- Daniela Cramer · Contact503-494-8742cramerda@ohsu.edu
- Nicole Marshall · Principal investigator
- Karen Gibbins · Sub-investigator
RecruitingUniversity of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
- Leigh Ann Shaver · Contactshaverla2@upmc.edu
- Anne-Marie Rick, MD · Principal investigator
RecruitingTexas Tech University Health Sciences Center School of Medicine.
Amarillo, Texas, United States
- Katie Boatler · Contactkatie.boatler@ttuhsc.edu
- Kaytlin Krutsch, PharnD · Principal investigator
- Teresa Baker, MD · Sub-investigator
RecruitingUniversity of Texas Medical Branch - Galveston
Galveston, Texas, United States
- Sashank Komanduri · Contactsakomand@utmb.edu
- Lizzet Aguillon · Contact409-772-0305liaguill@utmb.edu
- Gayle Olson, MD · Principal investigator
RecruitingUniversity of Texas Health Science Center at Houston
Houston, Texas, United States
- Felicia Ortiz · Contact713-500-6467felecia.ortiz@uth.tmc.edu
- Pamela Berens, MD · Principal investigator
RecruitingThe Women's Hospital of Texas
Houston, Texas, United States
- Olaide Balogun · Contactolaide.ashimibalogun@pediatrix.comare.com
- Olaide Balogun, MD · Principal investigator
RecruitingUniversity of Texas Health Science Center
San Antonio, Texas, United States
- Janette Rodela, RN · Contact615-344-9551Janette.Rodela@HCAhealthcare.com
- Olaide Balogun, MD · Principal investigator
- Kaashif Ahmad, MD · Sub-investigator
RecruitingUniversity of Utah
Salt Lake City, Utah, United States
- Kelly Christensen · Contact801-674-7234kelly.vorwaller@hsc.utah.edu
- Kathleen Job · Principal investigator
- Lauren Theilen · Sub-investigator
RecruitingNorthwestern University
Chicago, Illinois, United States
CompletedIndiana University Health
Indianapolis, Indiana, United States
CompletedUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Active, not recruitingUniversity of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States
CompletedUniversity of North Carolina Hospital
Chapel Hill, North Carolina, United States
CompletedHospital of the University of Pennsylvania Department of Maternal Fetal Medicine
Philadelphia, Pennsylvania, United States
CompletedUniversity of Washington
Seattle, Washington, United States
Completed
2 sites outside the US
Lawson Health Research Institute
London, Ontario, Canada
CompletedCentre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Completed
Study team
Sponsor
Duke University
Study ID Pro00088919
Principal investigator
Samia Aleem, MD
Duke University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.