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Fetal Alcohol Damage Prevention Study

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00696085
Collaborator
(none)
612
Enrollment
1
Location
1
Arm
47
Duration (Months)
13
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief motivational intervention
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
612 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prevention of Fetal Alcohol Damage Using Maternal Blood Markers
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Feb 1, 2008
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: 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.
Other Names:
  • Motivational Intervention
  • Brief Intervention

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Decrease in drinking [during the pregnancy]

    Secondary Outcome Measures

    1. improved infant size [after pregnancy finished]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Lewis B Holmes, M.D., Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00696085
    Other Study ID Numbers:
    • 1999-P-008236/21
    First Posted:
    Jun 12, 2008
    Last Update Posted:
    Jun 12, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    fetal alcohol exposure
    blood markers of alcohol use
    brief intervention
    Additional relevant MeSH terms:
    Fetal Alcohol Spectrum Disorders
    Substance-Related Disorders

    Study Results

    No Results Posted as of Jun 12, 2008