Prenatal Alcohol Biomarker Study in Uruguay

Fetal Alcohol Syndrome Clinical Trial

Official title:

Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600624
• Other study ID #: STU00200504
• Status: Completed
• Start date: August 18, 2016
• Est. completion date: July 2019

Study information

• Verified date: April 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn.

Description:

The goal of the proposed research study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn children, in a country (Uruguay) where significant alcohol use is common during pregnancy. Maternal alcohol biomarker assays will include ethyl glucuronide (EtG) in hair and nails and PEth in blood obtained at the time of delivery. Newborn umbilical cord and routine 48 hour heel stick blood will be collected to assess newborn PEth levels. Maternal biomarker levels will be compared to patient self-reported alcohol use. This proposed design is a cross-sectional study that will include 1,800 women 18 years and older and their newborns. Women who are admitted to one of two selected public health care hospitals in Montevideo, Uruguay (Hospital Pereira Rossell and Servicio Medico Integral) for obstetrical care will be recruited to participate in the study. Power estimates suggest that 1,800 maternal/infant pairs will give us sufficient power (>90%) to estimate the predictive validity of this biomarker as a routine newborn screening test.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Countries where clinical trial is conducted

United States,  Uruguay, 

Outcome

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.