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临床试验/NCT02600624
NCT02600624已完成不适用

Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay

Northwestern University2 个研究点 分布在 2 个国家目标入组 1,412 人开始时间: 2016年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,412
试验地点
2
主要终点
Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Not meeting the appropriate inclusion criteria or providing consent

结局指标

主要结局

Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay

时间窗: The maternal questionnaire will occur during the 48 hrs following childbirth

Conduct a formative assessment of the prevalence and patterns of maternal alcohol consumption during pregnancy and the relationship of these reported patterns to maternal biomarker levels (EtG in hair and nails and PEth in blood) in a large sample (n=1800) of pregnant women in Montevideo, Uruguay.

次要结局

  • Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay(PEth and EtG Biomarkers from the mothers and newborns will be collected during the 48 hrs after childbirth.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Fleming

Professor in Psychiatry and Behavioral Sciences and Family and community Medicine

Northwestern University

研究点 (2)

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