The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/2/2019 |
| Start Date: | November 2012 |
| End Date: | June 30, 2017 |
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
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
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.
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.
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
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