Fetal Alcohol Damage Prevention Study
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00696085
First received: June 6, 2008
Last updated: June 11, 2008
Last verified: June 2008
| Tracking Information | |||||
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| First Received Date ICMJE | June 6, 2008 | ||||
| Last Updated Date | June 11, 2008 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Decrease in drinking [ Time Frame: during the pregnancy ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00696085 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
improved infant size [ Time Frame: after pregnancy finished ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fetal Alcohol Damage Prevention Study | ||||
| Official Title ICMJE | Prevention of Fetal Alcohol Damage Using Maternal Blood Markers | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | 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.
Other Names:
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| Study Arm (s) | I
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.
Intervention: Behavioral: Brief motivational intervention |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 612 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00696085 | ||||
| Other Study ID Numbers ICMJE | 1999-P-008236/21 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lewis B. Holmes, M.D., Chief, Genetics Unit, MassGeneral Hospital for Children | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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