Clinical Trial: Prenatal Alcohol Biomarker Study in Uruguay

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay

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 Summary: 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.
Sponsor: Northwestern University

Current Primary Outcome: Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: November 3, 2015
Date Started: August 18, 2016
Date Completion: July 2019
Last Updated: May 5, 2017
Last Verified: May 2017