Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
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|ClinicalTrials.gov Identifier: NCT02759874|
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2016
Last Update Posted : September 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Pregnancy||Device: specialized breathalyzer w face recognition technology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Intervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone
Device: specialized breathalyzer w face recognition technology
Other Name: Soberlink
No Intervention: Control Group
No intervention. No breathalyzer given. Access granted by participant to IHE to collect data from Alberta Health Services (medical records)
- Change in FASD Birthrate Levels [ Time Frame: 3 years ]Binary- yes or no dx FASD within 3 years of birth
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759874
|Principal Investigator:||Andy Greenshaw, PhD||Department of Psychiatry, University of Alberta|
|Study Director:||Egon Jonsson, PhD||Institute of Health Economics Executive Director and CEO|