- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02793700
Pharmacokinetics (PK) and Modeling of Betamethasone Therapy in Threatened Preterm Birth
March 28, 2022 updated by: David Haas, Indiana University
Pharmacokinetics 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 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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
210
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Eskenazi Hospital
-
Indianapolis, Indiana, United States, 46202
- IUH Methodist Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 30 days of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (ACTUAL)
March 1, 2022
Study Completion (ACTUAL)
March 1, 2022
Study Registration Dates
First Submitted
May 31, 2016
First Submitted That Met QC Criteria
June 7, 2016
First Posted (ESTIMATE)
June 8, 2016
Study Record Updates
Last Update Posted (ACTUAL)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1604640151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
No plan for availability of individual participant data
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Premature Labor
-
Assistance Publique Hopitaux De MarseilleUnknownPremature LabourFrance
-
GlaxoSmithKlineCompletedObstetric Labour, Premature | Premature LaborUnited States
-
Hospital Clinic of BarcelonaCompletedThreatened Premature LaborSpain
-
Ferring PharmaceuticalsCompletedPremature Birth | Labor, PrematureFinland, Belgium, Czech Republic, Lithuania, Poland, Romania
-
Eunice Kennedy Shriver National Institute of Child...University of Alabama at BirminghamCompletedLabor, PrematureUnited States
-
The University of Texas Medical Branch, GalvestonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPremature Birth | Pregnancy | Premature LaborUnited States
-
State University of New York at BuffaloCompleted
-
NYU Langone HealthWithdrawnPremature Birth | Premature LaborUnited States
-
Yale UniversityWithdrawnPremature Birth | Premature Labor
-
Mohamed Sayed AbdelhafezRecruiting