Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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) |
-
Behavioral: brief intervention
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 |
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| Contact: Ariel Many, MD | 972524266954 | arielm@tasmc.health.gov.il |
| Contact: Einat Peles, Ph.D. | einatp@tasmc.health.gov.il |
| Israel | |
| Poria Medical Center | Not yet recruiting |
| Tiberias, Israel | |
| Contact: Yuri perlitz, MD YPerlitz@poria.health.gov.il | |
| Principal Investigator: Moshe Ben Ami, Proffesor | |
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 May 23, 2013