NCT02600624

Prenatal Alcohol Biomarker Study in Uruguay

Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,412 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fetal Alcohol Syndrome

Timeline

• Start date: 2016-08-18
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2015-11-09
• Last updated: 2020-04-03

Locations

2 sites across 2 countries: United States, Uruguay