Prenatal Alcohol Biomarker Study in Uruguay

NCT02600624 | Completed

• 1 other identifier: STU00200504
• Study Type: observational
• Target: 1,412
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Fetal Alcohol Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Participants

Women who are in active labor and their newborn infants.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women who are admitted public health care hospitals in Montevideo, Uruguay (Hospital Pereira Rossell) for obstetrical care will be recruited to participate in the study.

You may qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Clínica Ginecología/Obstétrica del Hospital General de las Fuerzas Armadas de Uruguay

Montevideo, Uruguay

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal alcohol biomarker assays will include ethylglucuronide (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

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Michael Fleming, MD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Psychiatry and Behavioral Sciences and Family and community Medicine

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 9, 2015
• Study Start: August 18, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); UR (1)