Prenatal Alcohol Biomarker Study in Uruguay

Completed

• Conditions: Fetal Alcohol Syndrome

• Registration Number: NCT02600624
• Lead Sponsor: Northwestern University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Study Start: 2016-08-18
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1412

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

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Exclusion Criteria

• Not meeting the appropriate inclusion criteria or providing consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay	The maternal questionnaire will occur during the 48 hrs following childbirth	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.

Secondary Outcome Measures

Name	Time	Method
Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay	PEth and EtG Biomarkers from the mothers and newborns will be collected during the 48 hrs after childbirth.	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.

Trial Locations

Locations (2)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Clínica Ginecología/Obstétrica del Hospital General de las Fuerzas Armadas de Uruguay; 🇺🇾 Montevideo, Uruguay