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Fetal Alcohol Damage Prevention Study

Prevention of Fetal Alcohol Damage Using Maternal Blood Markers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00696085
Enrollment
612
Registered
2008-06-12
Start date
2004-03-31
Completion date
2008-02-29
Last updated
2008-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Alcohol Syndrome, Substance Abuse

Keywords

fetal alcohol exposure, blood markers of alcohol use, brief intervention

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.

Interventions

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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Decrease in drinkingduring the pregnancy

Secondary

MeasureTime frame
improved infant sizeafter pregnancy finished

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026