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

Not Applicable

• Conditions: Alcoholism; Pregnancy

• Registration Number: NCT02759874
• Lead Sponsor: Institute of Health Economics, Canada

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Pregnant, Alcoholic, actively in treatment for alcoholism addiction

Exclusion Criteria

• Not pregnant, not in treatment/therapy for addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in FASD Birthrate Levels	3 years	Binary- yes or no dx FASD within 3 years of birth