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| Sponsored by: |
Massachusetts General Hospital |
|---|---|
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00696085 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Fetal Alcohol Syndrome Substance Abuse |
Behavioral: Brief motivational intervention |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Prevention of Fetal Alcohol Damage Using Maternal Blood Markers |
| Enrollment: | 612 |
| Study Start Date: | March 2004 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I
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.
|
Behavioral: Brief motivational intervention
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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Lewis B Holmes, M.D. | Massachusetts General Hospital |
More Information
| Responsible Party: | MassGeneral Hospital for Children ( Lewis B. Holmes, M.D., Chief, Genetics Unit ) |
| Study ID Numbers: | 1999-P-008236/21 |
| Study First Received: | June 6, 2008 |
| Last Updated: | June 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00696085 |
| Health Authority: | United States: Institutional Review Board |
|
fetal alcohol exposure blood markers of alcohol use brief intervention |
|
Alcohol-Induced Disorders Fetal Diseases Fetal Alcohol Syndrome Pregnancy Complications Mental Disorders Fetal alcohol syndrome |
Substance-Related Disorders Disorders of Environmental Origin Alcohol-Related Disorders Alcohol Drinking Ethanol |
|
Pathologic Processes Disease Syndrome |
