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Pharmacokinetics (PK) and Modeling of Betamethasone Therapy in Threatened Preterm Birth

NCT02793700 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2022-03-29

No results posted yet for this 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.

Conditions

  • Premature Labor

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • David M Haas, MD, MS · Indiana University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793700 on ClinicalTrials.gov