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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
June 6, 2008
June 12, 2008
June 12, 2008
March 2004
February 2008   (Final data collection date for primary outcome measure)
Decrease in drinking [ Time Frame: during the pregnancy ]
Same as current
No Changes Posted
improved infant size [ Time Frame: after pregnancy finished ]
Same as current
Not Provided
Not Provided
 
Fetal Alcohol Damage Prevention Study
Prevention of Fetal Alcohol Damage Using Maternal Blood Markers
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Fetal Alcohol Syndrome
  • Substance Abuse
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
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.
Intervention: Behavioral: Brief motivational intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
612
February 2008
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00696085
1999-P-008236/21
No
Not Provided
Not Provided
Lewis B. Holmes, M.D., Chief, Genetics Unit, MassGeneral Hospital for Children
Massachusetts General Hospital
Not Provided
Principal Investigator: Lewis B Holmes, M.D. Massachusetts General Hospital
Massachusetts General Hospital
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP