Clinical trial NCT02600624: Prenatal Alcohol Biomarker Study in Uruguay
Official title: Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Alcohol Syndrome
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 1412
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are admitted public health care hospitals in Montevideo, Uruguay (Hospital Pereira Rossell) for obstetrical care will be recruited to participate in the study.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
timeFrame: The maternal questionnaire will occur during the 48 hrs following childbirth
Secondary outcomes:
measure: Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
timeFrame: PEth and EtG Biomarkers from the mothers and newborns will be collected during the 48 hrs after childbirth.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Montevideo
country: Uruguay
facility: Clínica Ginecología/Obstétrica del Hospital General de las Fuerzas Armadas de Uruguay
Study officials:
affiliation: Northwestern University
name: Michael Fleming, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: