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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01252706
First received: December 1, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention
Pregnancy
Behavioral: brief intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • nicotine, alcohol and drug abstinence [ Time Frame: during pregnancy until labor ] [ Designated as safety issue: No ]
    nicotine alcohol and drug abstinence will be evaluate during pregnancy until labor


Secondary Outcome Measures:
  • newborn weight of birth [ Time Frame: at labor ] [ Designated as safety issue: No ]
    data about newborn at labor and it relation to brief intervention of mother will be deternined


Estimated Enrollment: 10000
Study Start Date: March 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: brief intervention
    limit time giving information, motivation, empathy, responsibility, self control
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252706

Contacts
Contact: Ariel Many, MD 972524266954 arielm@tasmc.health.gov.il
Contact: Einat Peles, Ph.D. einatp@tasmc.health.gov.il

Locations
Israel
Poria Medical Center Not yet recruiting
Tiberias, Israel
Contact: Yuri perlitz, MD       YPerlitz@poria.health.gov.il   
Principal Investigator: Moshe Ben Ami, Proffesor         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Ministry of Health, Israel
  More Information

No publications provided

Responsible Party: Ariel Mani, Tel Aviv Souraski Medical Center
ClinicalTrials.gov Identifier: NCT01252706     History of Changes
Other Study ID Numbers: TASMC-10-AM-292-CTIL
Study First Received: December 1, 2010
Last Updated: December 1, 2010
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on November 24, 2014