Neonatal Respiratory Distress Syndrome Clinical Trial
Official title:
The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
NCT number | NCT02112513 |
Other study ID # | 1108006470 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | June 30, 2017 |
Verified date | February 2019 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 160 |
Est. completion date | June 30, 2017 |
Est. primary completion date | November 8, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Eskenazi Hospital | Indianapolis | Indiana |
United States | Methodist Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory distress syndrome | 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. | At least 30 days after delivery, the maternal and neonatal charts will be reviewed |
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