Alcoholism, Pregnancy
Conditions
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.
Interventions
DEVICEspecialized breathalyzer w face recognition technology
Sponsors
University of Alberta
SoberLink, LLC
Alberta Innovates Health Solutions
Alberta Health services
Institute of Health Economics, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant, Alcoholic, actively in treatment for alcoholism addiction
Exclusion criteria
* Not pregnant, not in treatment/therapy for addiction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FASD Birthrate Levels | 3 years | Binary- yes or no dx FASD within 3 years of birth |
Outcome results
None listed