Prenatal Alcohol Biomarker Study in Uruguay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1412 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-18

Study Completion Date

2019-07-31

Brief Summary

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

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Detailed Description

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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

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Fetal Alcohol Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants

Women who are in active labor and their newborn infants.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No