NCT01252706

Brief Summary

The aims is to evaluate the rate of exposure to alcohol, psychoactive substance and nicotine among pregnant women in periphery hospital (Poria) and in the center of Tel Aviv (Ichilov) and to evaluate study Brief Intervention impact on reduction exposure, and its effect on newborn outcomes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 3, 2010

Status Verified

November 1, 2010

Enrollment Period

1 year

First QC Date

December 1, 2010

Last Update Submit

December 1, 2010

Conditions

Pregnancy

Keywords

brief interventionalcoholnicotinedrug abuse

Outcome Measures

Primary Outcomes (1)

  • nicotine, alcohol and drug abstinence

    nicotine alcohol and drug abstinence will be evaluate during pregnancy until labor

    during pregnancy until labor

Secondary Outcomes (1)

  • newborn weight of birth

    at labor

Interventions

brief interventionBEHAVIORAL

limit time giving information, motivation, empathy, responsibility, self control

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women who smoke cigarets, drink alcohol and or abuse any drugs

You may not qualify if:

  • pregnant women who do not smoke cigarets, drink alcohol and or abuse any drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poria Medical Center

Tiberias, Israel

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Ariel Many, MD

CONTACT

972524266954arielm@tasmc.health.gov.il

Einat Peles, Ph.D.

CONTACT

einatp@tasmc.health.gov.il

Study Design

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

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 3, 2010

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

December 3, 2010

Record last verified: 2010-11

Locations

IL(1)