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NCT03511118 · ClinicalTrials.gov registry record
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
A clinical trial of Lactating Women on Select DOI and Breastfed Infants of Mothers on Select DOI, sponsored by Duke University.
- Recruiting
- Registry status
- 1,600
- Enrollment target
- 20
- Study locations
NCT03511118: Recruiting study of Lactating Women on Select DOI and Breastfed Infants of Mothers on Select DOI, sponsored by Duke University.
NCT03511118 is a study of Lactating Women on Select DOI and Breastfed Infants of Mothers on Select DOI that is actively recruiting participants, run by Duke University. The registered enrollment target is 1,600 participants. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03511118, a study of Lactating Women on Select DOI and Breastfed Infants of Mothers on Select DOI, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- 1,600 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Characterize the pharmacokinetics using maternal milk/plasma exposure ratio is calculated by dividing the BMS01 drug of interest breastmilk concentration by the BMS01 drug of interest in maternal plasma concentration.
Conditions Studied
Interventions
- DRUG Tranexamic acid (TXA)
- DRUG labetalol
- DRUG metformin
- DRUG nifedipine
- DRUG clindamycin
Study Locations (20)
Texas
- Texas Tech University Health Sciences Center School of Medicine. - Amarillo
- University of Texas Medical Branch - Galveston - Galveston
- University of Texas Health Science Center at Houston - Houston
- The Women's Hospital of Texas - Houston
- University of Texas Health Science Center - San Antonio
California
- University of California-San Diego Medical Center - La Jolla
- Loma Linda University Health - Loma Linda
Illinois
- Northwestern University - Chicago
- Ann and Robert H. Lurie Childrens Hospital of Chicago - Chicago
North Carolina
- University of North Carolina Hospital - Chapel Hill
- Duke University Maternal and Fetal Medicine - Durham
Pennsylvania
- Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine - Philadelphia
- University of Pittsburgh School of Medicine - Pittsburgh
Indiana
- Indiana University Health - Indianapolis
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Minnesota
- Children's Hospital and Clinics - Minneapolis - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,600 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2027-07-31 |
What NCT03511118 shows while recruiting
NCT03511118 is an observational study that tracks outcomes without assigning an intervention. Its 1,600 participants enrollment target places it among the larger protocols in the corpus.
The record links to 2 conditions, with Lactating Women on Select DOI appearing as the primary indexed condition, and to 5 interventions - of which Tranexamic acid (TXA) is the first listed.
NCT03511118 names 20 study sites across 12 states, led by Texas, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT03511118 about?
NCT03511118 is a clinical study titled "Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants". 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...
What is the current status of trial NCT03511118?
This trial is currently recruiting. The enrollment target is 1,600 participants. The study started on 2018-10-04. Estimated completion is 2027-07-31.
What conditions does trial NCT03511118 study?
This clinical trial studies the following conditions: Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI.
What interventions are being tested in trial NCT03511118?
The interventions under investigation include: Tranexamic acid (TXA) (DRUG), labetalol (DRUG), metformin (DRUG), nifedipine (DRUG), clindamycin (DRUG).
Who is sponsoring clinical trial NCT03511118?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03511118 being conducted?
This trial has 20 study locations across California, Illinois, Indiana, Iowa, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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