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

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Respiratory Distress Syndrome

Phase: Phase 4

Status: Recruiting

Sponsored by: Indiana University

Official(s) and/or principal investigator(s):
David Haas, MD, MSc, Principal Investigator, Affiliation: Indiana University School of Medicine

Overall contact:
David Haas, MD. MSc, Phone: (317) 880-3960, Email: dahaas@iu.edu

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

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Respiratory distress syndrome

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

David Haas, MD. MSc, Phone: (317) 880-3960, Email: dahaas@iu.edu

Eskenazi Hospital, Indianapolis, Indiana 46202, United States; Recruiting
David Haas, MD. MSc, Phone: 317-880-3960, Email: dahaas@iu.edu
Sara Quinney, PharmD, PhD, Sub-Investigator
Cindy Evrard, BSN, RN, Sub-Investigator

Methodist Hospital, Indianapolis, Indiana 46202, United States; Recruiting
David Haas, MD, Phone: 317-880-3960, Email: dahaas@iu.edu
Sara Quinney, PharmD, PhD, Sub-Investigator
Cindy Evrard, BSN, RN, Sub-Investigator

Additional Information

Starting date: November 2012
Last updated: June 22, 2015

Page last updated: August 23, 2015

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