CClinicalTrials.gg
Status unknownNCT01252706Updated Dec 3, 2010

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

An interventional study of brief intervention in Pregnancy, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2010-12-03.

Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10,000
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy

Keywords

  • brief intervention
  • alcohol
  • nicotine
  • drug abuse
03

In context

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • pregnant women who smoke cigarets, drink alcohol and or abuse any drugs

Exclusion criteria

Exclusion Criteria:

  • pregnant women who do not smoke cigarets, drink alcohol and or abuse any drugs
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10,000 participants (estimated)

Interventions

  • Behavioralbrief intervention

    limit time giving information, motivation, empathy, responsibility, self control

06

What researchers measure

Primary outcomes

  1. nicotine, alcohol and drug abstinence

    nicotine alcohol and drug abstinence will be evaluate during pregnancy until labor

    Time frame: during pregnancy until labor

Secondary outcomes

  1. newborn weight of birth

    data about newborn at labor and it relation to brief intervention of mother will be deternined

    Time frame: at labor

07

Study locations

1 site
  • Poria Medical Center
    Tiberias, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01252706
Lead sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Ministry of Health, Israel
First posted
Dec 3, 2010
Start date
Mar 2011
Primary completion
Mar 2012 (estimated)
Completion
Jul 2012 (estimated)
Last update
Dec 3, 2010

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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