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Indomethacin PK and PD Therapy in Pregnancy
NCT02451228 · View on ClinicalTrials.gov ↗
Study Summary
This study will follow pregnant women who are taking indomethacin as Standard of Care (SOC) for the indications of preterm labor (PTL), short cervix, or other indications, to evaluate the pharmacokinetics (PK), what the body does to the drug, and pharmacodynamics (PD), effectiveness of the drug in treating the specific intended disease process of this medication. This will help us develop more information for medication dosing specific to pregnant women experiencing preterm labor. Indomethacin is often prescribed to pregnant women presenting with preterm labor or shortened cervix, which places them at risk for preterm labor and delivery. Indomethacin has been used since the 1970s to prolong pregnancy by decreasing uterine contractions. However, despite the widespread use of indomethacin in pregnancy, there is limited information available to help physicians determine how much indomethacin to prescribe and how often to prescribe it.
Conditions Studied
Interventions
- OTHER Serial blood collection
Study Locations (6)
Alabama
- University of Alabama — Birmingham
Mississippi
- University of Mississippi Medical Center — Jackson
New York
- Columbia University — New York
North Carolina
- Duke University — Durham
Texas
- University of Texas Medical Branch, Dept of OB/GYN — Galveston
Utah
- University of Utah — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02451228
The ClinicalTrials.gov registry entry for NCT02451228 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 132 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention — of which Serial blood collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02451228 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Alabama, Mississippi, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02451228 about?
NCT02451228 is a clinical study titled "Indomethacin PK and PD Therapy in Pregnancy". This study will follow pregnant women who are taking indomethacin as Standard of Care (SOC) for the indications of preterm labor (PTL), short cervix, or other indications, to evaluate the pharmacokinetics (PK), what the body does to the drug, and pharmacodynamics (PD), effectiveness of the drug in t...
What is the current status of trial NCT02451228?
This trial is currently completed. The enrollment target is 62 participants. The study started on 2015-05. Estimated completion is 2018-12-31.
What conditions does trial NCT02451228 study?
This clinical trial studies the following conditions: Pregnancy, Premature Birth, Premature Labor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02451228?
The interventions under investigation include: Serial blood collection (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02451228?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 132 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02451228 being conducted?
This trial has 6 study locations across Alabama, Mississippi, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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