Fetal Alcohol Syndrome Clinical Trial
Official title:
Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
NCT number | NCT02600624 |
Other study ID # | STU00200504 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 18, 2016 |
Est. completion date | July 2019 |
Verified date | April 2020 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn.
Status | Completed |
Enrollment | 1412 |
Est. completion date | July 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Inclusion criteria for experimental group (n=1,800) - Pregnant women 18 years and older - Admitted in active labor as well as their newborn child - Well enough to participate in the research interview - Able to provide fingernail, hair, and blood spot samples - All subjects must have given signed, informed consent prior to registration Exclusion Criteria: - Not meeting the appropriate inclusion criteria or providing consent |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Memorial Hospital | Chicago | Illinois |
Uruguay | Clínica Ginecología/Obstétrica del Hospital General de las Fuerzas Armadas de Uruguay | Montevideo |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States, Uruguay,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay | Conduct a formative assessment of the prevalence and patterns of maternal alcohol consumption during pregnancy and the relationship of these reported patterns to maternal biomarker levels (EtG in hair and nails and PEth in blood) in a large sample (n=1800) of pregnant women in Montevideo, Uruguay. | The maternal questionnaire will occur during the 48 hrs following childbirth | |
Secondary | Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay | Biomarkers will be collected to determine the correlations between maternal self-report of alcohol consumption, maternal alcohol biomarker levels and newborn PEth concentration levels at birth. It will also help identify the sensitivity and specificity of PEth and the predictive value of newborn PEth levels; and the half-life and window of detection of PEth in newborns by examining the kinetics of PEth elimination. | PEth and EtG Biomarkers from the mothers and newborns will be collected during the 48 hrs after childbirth. |
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