Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02600624
Study type Observational
Source Northwestern University
Contact
Status Completed
Phase
Start date August 18, 2016
Completion date July 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00996528 - Neighborhood Alcohol & HIV Prevention in South African Townships (Philani) Phase 3
Completed NCT00164554 - Fetal Alcohol Syndrome/ARND Research Consortion Phase 1/Phase 2
Completed NCT00164229 - Fetal Alcohol Syndrome: Socio-Cognitive Habilitation Phase 1/Phase 2
Recruiting NCT05534568 - The Oklahoma Parent-Child Assistance Program N/A
Recruiting NCT05385328 - Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations
Completed NCT01911299 - Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders Phase 2
Terminated NCT00747630 - Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome (FAS) Phase 0
Recruiting NCT04332172 - Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy N/A
Completed NCT00696085 - Fetal Alcohol Damage Prevention Study N/A
Recruiting NCT00418262 - Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD Phase 3
Completed NCT01149538 - Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure Phase 1/Phase 2
Recruiting NCT03371641 - In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions N/A
Completed NCT00164346 - Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND) Phase 1/Phase 2
Completed NCT01994603 - Expansion to Interdisciplinary HIV Prevention in Women N/A
Completed NCT00417794 - Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD Phase 1
Completed NCT00244062 - Healthy Moms Alcohol Intervention N/A
Recruiting NCT04395196 - RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure Phase 2
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A