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NCT05099484 · ClinicalTrials.gov registry record
Medications in Breast Milk: A Convenience Pharmacokinetic Study
A clinical trial of Pregnancy Related, sponsored by Indiana University.
- Completed
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT05099484: Completed study of Pregnancy Related, sponsored by Indiana University.
NCT05099484 is a study of Pregnancy Related that has completed, run by Indiana University. The registered enrollment target is 30 participants, below the 1,963-participant average among 99 other Pregnancy Related trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05099484, a study of Pregnancy Related, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The benefits of breastfeeding and human milk consumption by infants has been clearly demonstrated. Benefits to the infant include reduction of infant and childhood diseases and allergies. Benefits to the woman include more rapid return to pre-pregnancy weight and reduced risk of health problems such as cardiovascular disease and diabetes in the future. Many women take medications as part of their standard of care and for multiple medical reasons in the postpartum period, when breastfeeding occurs. This creates a need for information about the transfer of drugs taken by a woman into breast milk, and ultimately, to the infant. Unfortunately, there are limited pharmacokinetic (PK) data on many of the medications commonly taken by lactating women. Additionally, there are little data on how the PK of drugs are impacted by lactation, and how this may vary from woman to woman or with time throughout lactation. Uptake of drugs into breast milk can vary due to a number of factors, including drug lipophilicity; molecular weight; drug half-life; active transport in breast epithelial cells; protein binding in milk and plasma; and lipid composition of breast milk. In silico and animal models can provide some information on transfer of drugs into breast milk, however, there are large gaps remaining in our knowledge of drug transfer into human milk. This information is crucial to better inform providers and patients about the transfer of those drugs to human breast milk. The purpose of this study is to characterize the PK of specific drugs of interest taken by lactating women as part of their standard of care. The drugs of interest (DOI) will be based on medical relevance and availability throughout the course of the study. The purpose of this study is to characterize the PK of medications taken by lactating women as part of their standard of care.
Primary Outcome
Area under the plasma concentration versus time curve (AUC)
Conditions Studied
Interventions
- DRUG The MedMilk study
Study Locations (1)
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-15 |
| Est. Completion | 2022-09-01 |
What the finished NCT05099484 record still lists
NCT05099484 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,963-participant average among 99 other Pregnancy Related trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Pregnancy Related appearing as the primary indexed condition, and to 1 intervention - of which The MedMilk study is the first listed.
NCT05099484 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05099484 about?
NCT05099484 is a clinical study titled "Medications in Breast Milk: A Convenience Pharmacokinetic Study". The benefits of breastfeeding and human milk consumption by infants has been clearly demonstrated. Benefits to the infant include reduction of infant and childhood diseases and allergies. Benefits to the woman include more rapid return to pre-pregnancy weight and reduced risk of health problems such...
What is the current status of trial NCT05099484?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2021-01-15. Estimated completion is 2022-09-01.
What conditions does trial NCT05099484 study?
This clinical trial studies the following conditions: Pregnancy Related.
What interventions are being tested in trial NCT05099484?
The interventions under investigation include: The MedMilk study (DRUG).
Who is sponsoring clinical trial NCT05099484?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05099484 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05099484's enrollment target sits among peer trials
30 90th of 99 higher than 10 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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