NCT00696085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
612

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
Last Updated

June 12, 2008

Status Verified

June 1, 2008

Enrollment Period

3.9 years

First QC Date

June 6, 2008

Last Update Submit

June 11, 2008

Conditions

Fetal Alcohol SyndromeSubstance Abuse

Keywords

fetal alcohol exposureblood markers of alcohol usebrief intervention

Outcome Measures

Primary Outcomes (1)

  • Decrease in drinking

    during the pregnancy

Secondary Outcomes (1)

  • improved infant size

    after pregnancy finished

Study Arms (1)

I

OTHER

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.

Behavioral: Brief motivational intervention

Interventions

Brief motivational interventionBEHAVIORAL

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.

Also known as: Motivational Intervention, Brief Intervention
I

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women seen at one of the obstetric clinics in the study and willing to give a blood sample

You may not qualify if:

  • over 36 week gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum DisordersSubstance-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lewis B Holmes, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2008

First Posted

June 12, 2008

Study Start

March 1, 2004

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

June 12, 2008

Record last verified: 2008-06

Locations

US(1)