Prenatal Alcohol Biomarker Study in Uruguay



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:8/24/2018
Start Date:August 18, 2016
End Date:July 2019
Contact:Erika Oslakovic, MA, MS, LCPC
Email:e-oslakovic@northwestern.edu
Phone:312-503-3472

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Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay

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

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.

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

Exclusion Criteria:

- Not meeting the appropriate inclusion criteria or providing consent
We found this trial at
2
sites
2146 Bulevar General Artigas
Montevideo, 11600
Phone: 01159899669592
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Michael F Fleming, MD, MPH
Phone: 312-503-3472
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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