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

NCT02793700 | Completed

• 1 other identifier: 1604640151
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Betamethasone

Outcome Measures

Primary Outcomes (1)

• Diagnosis of respiratory distress syndrome

  The diagnosis of RDS made by the neonatologist staff based on clinical criteria

  up to 30 days of life

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women 18 years of age or older who are between 23-34 weeks gestation and being administered BMZ for fetal lung maturity.

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)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

IUH Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal whole blood Cord blood Placenta

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• David M Haas, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, MD, MS

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 8, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

US (2)