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Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology

NCT02759874 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-09-25

No results posted yet for this study

Summary

The Institute of Health Economics is conducting a study to determine how a breathalyzer linked to a cloud based alcohol monitoring system changes alcohol consumption during pregnancy in women with alcohol dependency issues.

IHE posits that the ability to self-monitor blood alcohol concentration and the ability to share sobriety via email or text with loved ones and counselors may reduce alcohol consumption and thus reduce the possibility of delivering a child with FASD.

The study will provide useful evidence for tailoring future optimal maternal and child healthcare for women, with the potential of decreasing healthcare utilization by prevention of FASD. Breathalyzer device usage plus secure document sobriety should improve patient monitoring convenience and demonstrate reductions in alcohol use outside of traditional office visits and patient self-reports.

Conditions

  • Alcoholism
  • Pregnancy

Interventions

DEVICE

specialized breathalyzer w face recognition technology

Sponsors & Collaborators

  • University of Alberta

    collaborator OTHER

  • SoberLink, LLC

    collaborator INDUSTRY

  • Alberta Innovates Health Solutions

    collaborator OTHER

  • Alberta Health services

    collaborator OTHER

  • Institute of Health Economics, Canada

    lead OTHER

Principal Investigators

  • Andy Greenshaw, PhD · Department of Psychiatry, University of Alberta

  • Egon Jonsson, PhD · Institute of Health Economics Executive Director and CEO

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-11-30
Completion
2018-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02759874 on ClinicalTrials.gov