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

I

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

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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