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

Not Applicable

• Conditions: Pregnancy

• Registration Number: NCT01252706
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Last Update Submitted: 2010-12-01
• Study First Posted: 2010-12-03
• Last Update Posted: 2010-12-03
• Study Start: 2011-03
• Primary Completion: 2012-03
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
nicotine, alcohol and drug abstinence	during pregnancy until labor	nicotine alcohol and drug abstinence will be evaluate during pregnancy until labor

Secondary Outcome Measures

Name	Time	Method
newborn weight of birth	at labor	data about newborn at labor and it relation to brief intervention of mother will be deternined

Trial Locations

Locations (1)

Poria Medical Center; 🇮🇱 Tiberias, Israel