Clinical trial NCT02112513: The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
Official title: The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Respiratory Distress Syndrome
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2014-04-14
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mothers with preterm labor (23 - 34 weeks) on antenatal corticosteroid for prevention of neonatal respiratory distress syndrome will be recruited

Brief 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

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 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

Primary outcomes:
measure: Respiratory distress syndrome
timeFrame: At least 30 days after delivery, the maternal and neonatal charts will be reviewed
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: David Haas, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: