The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome

Completed

• Conditions: Neonatal Respiratory Distress Syndrome

• Registration Number: NCT02112513
• Lead Sponsor: Indiana University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-11
• Study First Posted: 2014-04-14
• Primary Completion: 2016-11-08
• Study Completion: 2017-06-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory distress syndrome	At least 30 days after delivery, the maternal and neonatal charts will be reviewed	Respiratory Distress Syndrome is diagnosed clinically, by need for mechanical ventilation and oxygen for at least 48 hours, and the presence of radiologic chest findings.

Trial Locations

Locations (2)

Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States

Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States