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NCT02451228 · ClinicalTrials.gov registry record

Indomethacin PK and PD Therapy in Pregnancy

A clinical trial of Pregnancy and Premature Birth, sponsored by The University of Texas Medical Branch, Galveston.

Completed
Registry status
62
Enrollment target
6
Study locations

NCT02451228 is a study of Pregnancy and Premature Birth that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 62 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (93% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT02451228, a study of Pregnancy and Premature Birth, has completed, sponsored by The University of Texas Medical Branch, Galveston.

COMPLETED
Registry status
62 participants
Enrollment target
6
Study locations

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

Pregnancy Premature Birth Premature Labor

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

FieldValue
Enrollment Target 62 participants
Start Date 2015-05
Est. Completion 2018-12-31

Sponsor

The University of Texas Medical Branch, Galveston

203 total trials

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What the Registry Record Tells You About NCT02451228

The ClinicalTrials.gov registry entry for NCT02451228 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (93% lower). The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.

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.

NCT02451228 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Alabama, Mississippi, New York.

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.

What interventions are being tested in trial NCT02451228?

The interventions under investigation include: Serial blood collection (OTHER).

Who is sponsoring clinical trial NCT02451228?

This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.