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NCT02759874 Clinical Trial

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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02759874
Other study ID # Pro00055644
Secondary ID
Status Enrolling by invitation
Phase N/A
First received April 28, 2016
Last updated September 21, 2017
Start date November 2015
Est. completion date November 2018

Study information
Verified date September 2017
Source Institute of Health Economics, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 110
Est. completion date November 2018
Est. primary completion date November 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pregnant, Alcoholic, actively in treatment for alcoholism addiction

Exclusion Criteria:

- Not pregnant, not in treatment/therapy for addiction

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• specialized breathalyzer w face recognition technology

Locations
Country Name City State
n/a

Sponsors (5)
Lead Sponsor Collaborator
Institute of Health Economics, Canada Alberta Health Services, Alberta Innovates Health Solutions, SoberLink, LLC, University of Alberta

Outcome
Type Measure Description Time frame Safety issue
Primary Change in FASD Birthrate Levels Binary- yes or no dx FASD within 3 years of birth 3 years
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