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Fetal Alcohol Damage Prevention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00696085
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : June 12, 2008
Information provided by:
Massachusetts General Hospital

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
Fetal Alcohol Syndrome Substance Abuse Behavioral: Brief motivational intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Decrease in drinking [ Time Frame: during the pregnancy ]

Secondary Outcome Measures :
  1. improved infant size [ Time Frame: after pregnancy finished ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00696085

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Lewis B Holmes, M.D. Massachusetts General Hospital

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Responsible Party: Lewis B. Holmes, M.D., Chief, Genetics Unit, MassGeneral Hospital for Children Identifier: NCT00696085     History of Changes
Other Study ID Numbers: 1999-P-008236/21
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: June 2008
Keywords provided by Massachusetts General Hospital:
fetal alcohol exposure
blood markers of alcohol use
brief intervention
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pregnancy Complications
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs