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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02793700
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : July 28, 2020
Information provided by (Responsible Party):
David Haas, Indiana University

Tracking Information
First Submitted Date May 31, 2016
First Posted Date June 8, 2016
Last Update Posted Date July 28, 2020
Study Start Date July 2016
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2016)
Diagnosis of respiratory distress syndrome [ Time Frame: up to 30 days of life ]
The diagnosis of RDS made by the neonatologist staff based on clinical criteria
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Pharmacokinetics (PK) and Modeling of Betamethasone Therapy in Threatened Preterm Birth
Official Title Pharmacokinetics and Modeling of Betamethasone Therapy in Threatened Preterm Birth
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.
Detailed Description After consent, a maternal sample of whole blood will be obtained for DNA isolation. Investigators will collect plasma samples at 4 time points on all participants. These will be done at baseline (pre-dose), and 0.5-2 hours, 4-6 hours, and 22-24 hours after the first dose of BMZ is administered. Investigators will obtain serum for estriol measurement on all participants before or within 2 hours of antenatal corticosteroid administration and about 24 hours after each dose is given (betamethasone is administered as 2 doses 24 hours apart). Investigators will obtain a saliva sample for measurement of estriol at the same times. Participants will be offered optional participation in a more detailed PK portion of the study. Participants who consent to this part of the study will have additional plasma samples obtained at a schedule of sampling of approximately 10-15 hours after the first dose and then 6-8 hours, 24, and 48 hours after the 2nd dose. One sample will be collected at each of these times. At the time of delivery, umbilical cord blood will be collected before being discarded for DNA, serum and plasma. Four placenta sections will be collected. A maternal blood sample will also be obtained for serum and plasma. If the investigators are unable to obtain umbilical cord blood, a buccal swab will be collected from the baby for DNA extraction. A chart review will be done on the infant within 30 days of birth to review and record neonatal outcomes.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Maternal whole blood Cord blood Placenta
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.
Condition Premature Labor
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 21, 2017)
Original Estimated Enrollment
 (submitted: June 7, 2016)
Estimated Study Completion Date May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contact: David M Haas, MD, MS 317-880-3949
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02793700
Other Study ID Numbers 1604640151
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: No plan for availability of individual participant data
Responsible Party David Haas, Indiana University
Study Sponsor Indiana University
Collaborators Not Provided
Principal Investigator: David M Haas, MD, MS Indiana University
PRS Account Indiana University
Verification Date July 2020