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Fetal Alcohol Damage Prevention Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696085
First Posted: June 12, 2008
Last Update Posted: June 12, 2008
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.
Information provided by:
Massachusetts General Hospital
  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: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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

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

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.
Other Names:
  • Motivational Intervention
  • Brief Intervention

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00696085


Locations
United States, Massachusetts
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
  More Information

Responsible Party: Lewis B. Holmes, M.D., Chief, Genetics Unit, MassGeneral Hospital for Children
ClinicalTrials.gov Identifier: NCT00696085     History of Changes
Other Study ID Numbers: 1999-P-008236/21
First Submitted: June 6, 2008
First Posted: June 12, 2008
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:
Substance-Related Disorders
Fetal Alcohol Spectrum Disorders
Chemically-Induced Disorders
Mental Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs