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

December 1, 2010
December 1, 2010
March 2011
March 2012   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pregnancy
Behavioral: brief intervention
limit time giving information, motivation, empathy, responsibility, self control
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10000
July 2012
March 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
No
Contact: Ariel Many, MD 972524266954 arielm@tasmc.health.gov.il
Contact: Einat Peles, Ph.D. einatp@tasmc.health.gov.il
Israel
 
NCT01252706
TASMC-10-AM-292-CTIL
No
Ariel Mani, Tel Aviv Souraski Medical Center
Tel-Aviv Sourasky Medical Center
Ministry of Health, Israel
Not Provided
Tel-Aviv Sourasky Medical Center
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP