Pharmacokinetics (PK) and Modeling of Betamethasone Therapy in Threatened Preterm Birth
Completed
Conditions studied: Premature Labor
In brief
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.
Key facts
- Study ID
- NCT02793700
- Run by
- Indiana University
- People needed
- 210
- Starts
- 2016-07-01
- Expected to finish
- 2022-03-01
- Last updated by the study team
- 2022-03-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Gestational age between 23-34 weeks with a diagnosis of threatened preterm labor or preterm premature rupture of membranes, or other diagnosis with a high likelihood of preterm delivery where the provider is recommending administering antenatal corticosteroids
- Singleton gestation
- Live fetus at the time of enrollment
- Being administered antenatal corticosteroids to enhance lung maturity
- Ability to provide written informed consent to participate in the study
You may not qualify if…
- Maternal age <18 years old
- Major congenital anomalies
- Known severe abruptio placentae at the time of enrollment
- Multiple gestations
- Hepatic failure (history of hepatic failure, cirrhosis or 2- fold increase in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)
- Renal failure (serum creatinine > 2 mg/dl)
Where it is running
- Eskenazi Hospital — Indianapolis, Indiana, United States
- IUH Methodist Hospital — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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