Prenatal Alcohol Biomarker Study in Uruguay
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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.
Full 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.
Enrollment
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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
Trial design
1,412 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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