Overview

This trial is active, not recruiting.

Condition neonatal respiratory distress syndrome
Phase phase 4
Sponsor Indiana University
Collaborator University of California, Los Angeles
Start date November 2012
End date July 2017
Trial size 160 participants
Trial identifier NCT02112513, 1108006470

Summary

The objective of this project is to evaluate clinical significance of measuring maternal blood estriol levels, after the administration of antenatal corticosteroids to enhance lung maturity. The investigators will test for associations of the change in maternal estriol with the development of respiratory distress syndrome. The investigators are also interested in determining whether salivary estriol is a valid surrogate to estriol blood assays. In addition the investigators will correlate these changes to pharmacokinetic (PK), pharmacodynamics (PD), and pharmacogenetic measures of betamethasone administration and fetal respiratory outcome

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Serum Estriol measurement via different assays is complex, expensive, labor intensive, time consuming, and generally performed at specific reference labs. Salivary Estriol level is an ideal potential surrogate for serum Estriol. It is convenient, non-invasive, and expedient. It may not, however, be as sensitive as serum estriol concentrations at detecting the association with glucocorticoid response. This study will collect both samples to determine which one is better suited for clinical use in this condition.
we will determine if changes in maternal serum estriol represent a biomarker of response to antenatal corticosteroids as evidenced by neonatal development of RDS
we will determine if pharmacokinetic parameters and neonatal outcomes after antenatal corticosteroid use are associated with genetic polymorphisms in drug metabolizing enzymes, transporters, and steroid pathway genes
we will determine if maternal betamethasone concentrations and genetics are associated with maternal estriol changes or RDS development

Primary Outcomes

Measure
Respiratory distress syndrome
time frame: At least 30 days after delivery, the maternal and neonatal charts will be reviewed

Eligibility Criteria

Female participants at least 18 years old.

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 - Multiple gestations

Additional Information

Official title The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
Principal investigator David Haas, MD, MSc
Description We will obtain serum and saliva for estriol measurement before or within 2 hours of antenatal corticosteroid administration and about 24 hours after each dose is given. Women who consent to an optional PK portion of the study will have plasma samples obtained pre-dose and then on a schedule of approximately 0.5-2, 4-8, 10-15, 22-24 hours after the first dose and then 6-8, 24, and 48 hours after the 2nd dose. One sample will be collected in each of these times. A sample of whole blood will be obtained for DNA isolation. At the time of delivery, umbilical cord blood will be collected before being discarded for DNA and plasma. If we are unable to obtain umbilical cord blood, a buccal swab will be collected from the baby for DNA extraction.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Indiana University.