Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fetal Alcohol Damage Prevention Study

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00696085
First received: June 6, 2008
Last updated: June 11, 2008
Last verified: June 2008

June 6, 2008
June 11, 2008
March 2004
February 2008   (final data collection date for primary outcome measure)
Decrease in drinking [ Time Frame: during the pregnancy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00696085 on ClinicalTrials.gov Archive Site
improved infant size [ Time Frame: after pregnancy finished ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00696085
1999-P-008236/21
No
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