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Completed

NCT Number: NCT00696085

Fetal Alcohol Damage Prevention Study

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.

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Key information

Conditions

Fetal Alcohol Syndrome Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Spectrum Disorders Fetal Diseases Mental Disorders Pregnancy Complications Substance Abuse Substance-Related Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Motivational Intervention

Behavioral

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

Primary outcomes

  1. Decrease in drinking

    Time frame: during the pregnancy

Secondary outcomes

  1. improved infant size

    Time frame: after pregnancy finished

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Prevention of Fetal Alcohol Damage Using Maternal Blood Markers

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jun 12, 2008
Registry last updated
Jun 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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