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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Fetal Alcohol Damage Using Maternal Blood Markers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Decrease in drinking [ Time Frame: during the pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improved infant size [ Time Frame: after pregnancy finished ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 6, 2008
Last Updated: June 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
fetal alcohol exposure
blood markers of alcohol use
brief intervention

Additional relevant MeSH terms:
Fetal Alcohol Syndrome
Substance-Related Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Mental Disorders
Ethanol
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013