Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-31 @ 4:41 PM
Study NCT ID:
NCT01252706
Status:
UNKNOWN
Last Update Posted:
2010-12-03
First Post:
2010-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003419', 'term': 'Crisis Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-01', 'studyFirstSubmitDate': '2010-12-01', 'studyFirstSubmitQcDate': '2010-12-01', 'lastUpdatePostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nicotine, alcohol and drug abstinence', 'timeFrame': 'during pregnancy until labor', 'description': 'nicotine alcohol and drug abstinence will be evaluate during pregnancy until labor'}], 'secondaryOutcomes': [{'measure': 'newborn weight of birth', 'timeFrame': 'at labor', 'description': 'data about newborn at labor and it relation to brief intervention of mother will be deternined'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['brief intervention', 'alcohol', 'nicotine', 'drug abuse'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women who smoke cigarets, drink alcohol and or abuse any drugs\n\nExclusion Criteria:\n\n* pregnant women who do not smoke cigarets, drink alcohol and or abuse any drugs'}, 'identificationModule': {'nctId': 'NCT01252706', 'briefTitle': 'Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'orgStudyIdInfo': {'id': 'TASMC-10-AM-292-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'brief intervention', 'type': 'BEHAVIORAL', 'description': 'limit time giving information, motivation, empathy, responsibility, self control'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tiberias', 'country': 'Israel', 'contacts': [{'name': 'Yuri perlitz, MD', 'role': 'CONTACT', 'email': 'YPerlitz@poria.health.gov.il'}, {'name': 'Moshe Ben Ami, Proffesor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Poria Medical Center', 'geoPoint': {'lat': 32.79221, 'lon': 35.53124}}], 'centralContacts': [{'name': 'Ariel Many, MD', 'role': 'CONTACT', 'email': 'arielm@tasmc.health.gov.il', 'phone': '972524266954'}, {'name': 'Einat Peles, Ph.D.', 'role': 'CONTACT', 'email': 'einatp@tasmc.health.gov.il'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Health, Israel', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Ariel Mani', 'oldOrganization': 'Tel Aviv Souraski Medical Center'}}}}