Fetal Alcohol Damage Prevention Study

Mass General Brigham

Status: Completed

Conditions: Substance Abuse; Fetal Alcohol Syndrome

Treatments: Behavioral: Brief motivational intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00696085

1999-P-008236/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 612 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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612 participants in 1 patient group

I

Other group

Description:

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.

Treatment:

Behavioral: Brief motivational intervention