Back to resultsFetal Alcohol Damage Prevention Study
Primary Purpose
Fetal Alcohol Syndrome, Substance Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief motivational intervention
Sponsored by
About this trial
This is an interventional prevention trial for Fetal Alcohol Syndrome focused on measuring fetal alcohol exposure, blood markers of alcohol use, brief intervention
Eligibility Criteria
Inclusion Criteria:
- Pregnant women seen at one of the obstetric clinics in the study and willing to give a blood sample
Exclusion Criteria:
- over 36 week gestation
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
I
Arm Description
Pregnant women are recruited and screened for alcohol use using a validated alcoholism screening questionnaire. Those who screen positive are then entered into the next phase of the study.
Outcomes
Primary Outcome Measures
Decrease in drinking
Secondary Outcome Measures
improved infant size
Full Information
NCT ID
NCT00696085
First Posted
June 6, 2008
Last Updated
June 11, 2008
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00696085
Brief Title
Fetal Alcohol Damage Prevention Study
Official Title
Prevention of Fetal Alcohol Damage Using Maternal Blood Markers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study was to determine whether a series of blood markers of alcohol use obtained from alcohol using pregnant women could help them to change their behavior.
Detailed Description
This study involved screening pregnant women with an alcoholism screening questionnaire and obtaining blood from those women who screened positive and a subset of women who screened negative. Each woman who had blood drawn were informed of their results, educated about alcohol use in pregnancy and had a brief intervention about their alcohol use, if appropriate. They were monitored throughout the pregnancy with additional blood tests obtained, depending upon their stage in pregnancy. After birth the babies were examined for any signs of alcohol exposure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Syndrome, Substance Abuse
Keywords
fetal alcohol exposure, blood markers of alcohol use, brief intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
612 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Other
Arm Description
Pregnant women are recruited and screened for alcohol use using a validated alcoholism screening questionnaire. Those who screen positive are then entered into the next phase of the study.
Intervention Type
Behavioral
Intervention Name(s)
Brief motivational intervention
Other Intervention Name(s)
Motivational Intervention, Brief Intervention
Intervention Description
The women who have positive alcohol screening questionnaires and a random sample of women who screen negative are entered into the next phase of the study. They have blood drawn for the markers of alcohol use, are told of the results and are given brief intervention about alcohol use.
Primary Outcome Measure Information:
Title
Decrease in drinking
Time Frame
during the pregnancy
Secondary Outcome Measure Information:
Title
improved infant size
Time Frame
after pregnancy finished
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women seen at one of the obstetric clinics in the study and willing to give a blood sample
Exclusion Criteria:
over 36 week gestation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis B Holmes, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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Fetal Alcohol Damage Prevention Study
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