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NCT02793700 · ClinicalTrials.gov registry record
Pharmacokinetics (PK) and Modeling of Betamethasone Therapy in Threatened Preterm Birth
A clinical trial of Premature Labor, sponsored by Indiana University.
- Completed
- Registry status
- 210
- Enrollment target
- 2
- Study locations
NCT02793700: Completed study of Premature Labor, sponsored by Indiana University.
NCT02793700 is a study of Premature Labor that has completed, run by Indiana University. The registered enrollment target is 210 participants. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02793700, a study of Premature Labor, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- 210 participants
- Enrollment target
- 2
- Study locations
Study Summary
Respiratory distress syndrome (RDS) is a life-threatening condition for premature neonates. Antenatal glucocorticoids have been used clinically in women with threatened preterm birth to accelerate lung maturation for more than 40 years. The current treatment strategy for women with threatened preterm delivery is for a standard, "one size fits all" dosing with either betamethasone (BMZ) or dexamethasone. It is well known that pregnancy introduces additional variability in response to medication therapy with different physiological changes and alterations in the activity of drug metabolizing enzymes. The objective of this project is to evaluate the pharmacokinetic (PK), pharmacodynamic, and pharmacogenetic parameters of betamethasone (BMZ) and determine the differences in response and benefit in pregnancy. An individualized dosing approach to medications in pregnancy, such as BMZ, is crucial to optimize efficacy of this important medication.
Primary Outcome
The diagnosis of RDS made by the neonatologist staff based on clinical criteria
Conditions Studied
Study Locations (2)
Indiana
- Eskenazi Hospital - Indianapolis
- IUH Methodist Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2016-07 |
| Est. Completion | 2022-03 |
What the finished NCT02793700 record still lists
NCT02793700 is an observational study that tracks outcomes without assigning an intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Premature Labor appearing as the primary indexed condition, and to 0 interventions.
NCT02793700 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT02793700 about?
NCT02793700 is a clinical study titled "Pharmacokinetics (PK) and Modeling of Betamethasone Therapy in Threatened Preterm Birth". Respiratory distress syndrome (RDS) is a life-threatening condition for premature neonates. Antenatal glucocorticoids have been used clinically in women with threatened preterm birth to accelerate lung maturation for more than 40 years. The current treatment strategy for women with threatened preter...
What is the current status of trial NCT02793700?
This trial is currently completed. The enrollment target is 210 participants. The study started on 2016-07. Estimated completion is 2022-03.
What conditions does trial NCT02793700 study?
This clinical trial studies the following conditions: Premature Labor.
Who is sponsoring clinical trial NCT02793700?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02793700 being conducted?
This trial has 2 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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