Status:
COMPLETED
MilkScreen Home Test for Alcohol in Breast Milk
Lead Sponsor:
UpSpring Baby, Ltd.
Conditions:
Alcohol Concentrations in Body Fluids
Eligibility:
FEMALE
21+ years
Brief Summary
The purpose of this study is to evaluate the performance of the UpSpring Milkscreen Test for Alcohol in Breast Milk to detect alcohol in breast milk from lactating women.
Detailed Description
The Milkscreen Test for alcohol in Breast Milk is intended for use by lactating mothers as a rapid qualitative detection for the presence of alcohol in their breast milk prior to offering the breast m...
Eligibility Criteria
Inclusion
- Female
- Age equal to or greater than 21 years
- Actively breast-feeding
- Willing to drink at least one alcoholic beverage (wine or beer) during study in a controlled setting
- Willing to arrive to the study session prior to consuming any alcoholic beverages within the last 6 hours.
- Willing to attend single session study for 3-4 hours duration until their BAC drops below 0.06%
- Willing to accept designated driver or study-supplied transportation
- Willing to agree to not breast feed their infant for 2 hour following leaving the study session
- English language fluency
Exclusion
- Distance of more than 25 miles from study site
- Pregnant (hCG test will be administered prior to alcohol consumption)
- Communicable diseases (e.g., Flu)
- HIV Positive
- History of Alcoholism (Recorded on the CRF)
- Arriving to the study session with a BAC at or below 0.01%
- Any medical condition which precludes the subject from drinking alcohol
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00851656
Start Date
May 1 2008
End Date
July 1 2008
Last Update
February 26 2009
Active Locations (1)
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1
Zeis Consulting Group
San Marcos, California, United States, 92078