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

Pregnancy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01252706
• Other study ID #: TASMC-10-AM-292-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 1, 2010
• Last updated: December 1, 2010
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: November 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ariel Many, MD
• Phone: 972524266954
• Email: arielm[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Israel	Poria Medical Center	Tiberias

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Ministry of Health, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nicotine, alcohol and drug abstinence	nicotine alcohol and drug abstinence will be evaluate during pregnancy until labor	during pregnancy until labor	No
Secondary	newborn weight of birth	data about newborn at labor and it relation to brief intervention of mother will be deternined	at labor	No