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CompletedNCT00696085Updated Jun 12, 2008

Fetal Alcohol Damage Prevention Study

An interventional study of Brief motivational intervention in Fetal Alcohol Syndrome and Substance Abuse, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-12.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
612
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Fetal Alcohol Syndrome
  • Substance Abuse

Keywords

  • fetal alcohol exposure
  • blood markers of alcohol use
  • brief intervention
03

In context

Fetal Alcohol Spectrum Disorders

64 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.

This study's enrollment of 612 is above the median of 72 across 56 interventional studies indexed under Fetal Alcohol Spectrum Disorders.

Browse Fetal Alcohol Spectrum Disorders studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • over 36 week gestation
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
612 participants (actual)

Study arms

  • Other
    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.

    Behavioral: Brief motivational intervention

Interventions

  • BehavioralBrief 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.

    Also known as: Motivational Intervention, Brief Intervention

06

What researchers measure

Primary outcomes

  1. Decrease in drinking

    Time frame: during the pregnancy

Secondary outcomes

  1. improved infant size

    Time frame: after pregnancy finished

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2004, a primary completion of Feb 2008 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2008
First posted
Jun 12, 2008
Start
Mar 2004
Primary completionActual
Feb 2008
CompletionActual
Feb 2008
Last update
Jun 12, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00696085
First posted
Jun 12, 2008
Start date
Mar 2004
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Jun 12, 2008

Study contacts

Lewis B Holmes, M.D.
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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