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 ]
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. ]
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