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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2019
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Eskenazi Hospital Indianapolis Indiana
United States Methodist Hospital Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

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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