The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
Completed
Conditions studied: Neonatal Respiratory Distress Syndrome
In brief
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
Key facts
- Study ID
- NCT02112513
- Run by
- Indiana University
- People needed
- 160
- Starts
- 2012-11-01
- Expected to finish
- 2017-06-30
- Last updated by the study team
- 2019-02-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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
- Multiple gestations
Where it is running
- Eskenazi Hospital — Indianapolis, Indiana, United States
- Methodist Hospital — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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