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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Neonatal Respiratory Distress Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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salivary estriol measurement

Serum Estriol measurement via different assays is complex, expensive, labor intensive, time consuming, and generally performed at specific reference labs. Salivary Estriol level is an ideal potential surrogate for serum Estriol. It is convenient, non-invasive, and expedient. It may not, however, be as sensitive as serum estriol concentrations at detecting the association with glucocorticoid response. This study will collect both samples to determine which one is better suited for clinical use in this condition.

No interventions assigned to this group

serum estriol measure

we will determine if changes in maternal serum estriol represent a biomarker of response to antenatal corticosteroids as evidenced by neonatal development of RDS

No interventions assigned to this group

Betamethasone pharmacokinetic

we will determine if pharmacokinetic parameters and neonatal outcomes after antenatal corticosteroid use are associated with genetic polymorphisms in drug metabolizing enzymes, transporters, and steroid pathway genes

No interventions assigned to this group

betamethasone concentration and genetics

we will determine if maternal betamethasone concentrations and genetics are associated with maternal estriol changes or RDS development

No interventions assigned to this group

Eligibility Criteria

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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