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

Institute of Health Economics, Canada

Status: Unknown

Conditions: Alcoholism; Pregnancy

Treatments: Device: specialized breathalyzer w face recognition technology

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02759874

Pro00055644

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant, Alcoholic, actively in treatment for alcoholism addiction

Exclusion criteria

• Not pregnant, not in treatment/therapy for addiction

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

Experimental

Experimental group

Description:

Intervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone

Treatment:

Device: specialized breathalyzer w face recognition technology

Control Group

No Intervention group

Description:

No intervention. No breathalyzer given. Access granted by participant to IHE to collect data from Alberta Health Services (medical records)