Fetal Alcohol Damage Prevention Study

Not Applicable

Completed

• Conditions: Fetal Alcohol Syndrome; Substance Abuse
• Interventions: Behavioral: Brief motivational intervention

• Registration Number: NCT00696085
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2008-06
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-11
• Last Update Submitted: 2008-06-11
• Study First Posted: 2008-06-12
• Last Update Posted: 2008-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 612

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	Brief motivational intervention	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.

Primary Outcome Measures

Name	Time	Method
Decrease in drinking	during the pregnancy

Secondary Outcome Measures

Name	Time	Method
improved infant size	after pregnancy finished

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States