Fetal Alcohol Damage Prevention Study

Substance Abuse Clinical Trial

Official title:

Prevention of Fetal Alcohol Damage Using Maternal Blood Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696085
• Other study ID #: 1999-P-008236/21
• Status: Completed
• Phase: N/A
• First received: June 6, 2008
• Last updated: June 11, 2008
• Start date: March 2004
• Est. completion date: February 2008

Study information

• Verified date: June 2008
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 612
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Substance Abuse

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in drinking		during the pregnancy	No
Secondary	improved infant size		after pregnancy finished	No