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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252706
Recruitment Status : Unknown
Verified November 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 3, 2010
Last Update Posted : December 3, 2010
Ministry of Health, Israel
Information provided by:
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Pregnancy Behavioral: brief intervention Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : March 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : July 2012

Intervention Details:
  • Behavioral: brief intervention
    limit time giving information, motivation, empathy, responsibility, self control

Primary Outcome Measures :
  1. nicotine, alcohol and drug abstinence [ Time Frame: during pregnancy until labor ]
    nicotine alcohol and drug abstinence will be evaluate during pregnancy until labor

Secondary Outcome Measures :
  1. newborn weight of birth [ Time Frame: at labor ]
    data about newborn at labor and it relation to brief intervention of mother will be deternined

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01252706

Contact: Ariel Many, MD 972524266954
Contact: Einat Peles, Ph.D.

Poria Medical Center Not yet recruiting
Tiberias, Israel
Contact: Yuri perlitz, MD   
Principal Investigator: Moshe Ben Ami, Proffesor         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Ministry of Health, Israel

Responsible Party: Ariel Mani, Tel Aviv Souraski Medical Center Identifier: NCT01252706     History of Changes
Other Study ID Numbers: TASMC-10-AM-292-CTIL
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: November 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
brief intervention
drug abuse