Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention

NCT ID: NCT01252706

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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All pregnant women who will arrive to Poria (and third of pregnant who will arrive to Ichilov) ER, high risk, and follow-up clinic will be asked for alcohol exposure, smoking and psychoactive substance usage. Relevant women will be asked to participate in a brief intervention treatment for about 30 min by expert personal, and a follow-up by phone every 3 months during pregnancy and post deliver. In addition, through all the year, questionnaires about exposure will be given to all women who will have labor (about 3000 labors), and third of 10,000 expecting in Ichilov. We expect in the second half of the year, to have those who enrolled to the BI. New-born outcome of the BI group as compared to the non-BI group will be compared, as well as rate of alcohol/substance/nicotine abstinence and reduction.

Conditions

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Pregnancy

Keywords

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brief intervention alcohol nicotine drug abuse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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brief intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnant women who do not smoke cigarets, drink alcohol and or abuse any drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Israel

OTHER_GOV

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel Aviv Souraski Medical Center

Locations

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Poria Medical Center

Tiberias, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ariel Many, MD

Role: CONTACT

Phone: 972524266954

Email: [email protected]

Einat Peles, Ph.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Yuri perlitz, MD

Role: primary

Other Identifiers

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TASMC-10-AM-292-CTIL

Identifier Type: -

Identifier Source: org_study_id