Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 4:47 AM
Study NCT ID:
NCT00121368
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2005-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GN Tobacco Use Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-22', 'studyFirstSubmitDate': '2005-07-15', 'studyFirstSubmitQcDate': '2005-07-19', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tobacco use', 'timeFrame': 'Cross sectional'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Global Network', 'Maternal and child health', 'International', "Women's health", 'Tobacco', 'Smoking', 'Africa', 'Latin America', 'South America', 'Guatemala', 'Zambia', 'India', 'Argentina', 'Democratic Republic of the Congo'], 'conditions': ['Smoking']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://gn.rti.org/', 'label': "Global Network for Women's and Children's Health"}]}, 'descriptionModule': {'briefSummary': 'Smoking can contribute to many health problems for mothers and their babies. In developing countries, there is little information about the number of pregnant women that smoke and the reasons why some pregnant women choose to smoke. The purpose of this multi-site tobacco use survey is to obtain information on knowledge, attitudes and behaviors among pregnant women in diverse populations regarding tobacco products.', 'detailedDescription': 'Smoking is regarded as one of the few potentially preventable factors associated with low birth weight, very preterm birth and perinatal death. In an effort to determine the prevalence of tobacco use (smoking and smokeless tobacco) and to collect relevant data in support of a potential smoking prevention or cessation intervention, a multi-site tobacco use survey is being conducted in several countries. The survey will be used to obtain information on knowledge, attitudes and behaviors among pregnant women in diverse populations regarding tobacco products.\n\nThe primary outcome is tobacco use status during pregnancy. Secondary outcomes include: knowledge and attitudes regarding tobacco products, health hazards of tobacco use and environmental tobacco smoke (ETS) exposure.\n\nSample size of 750 per country was calculated under the assumptions that the prevalence of tobacco use could be as low as 0.05 with a coefficient of variation of approximately 15% and a prevalence of 0.10 with a CV of approximately 11%.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women 18-45', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women of legal consent and child-bearing age (18-45)\n* Attendance at a participating clinic\n\nExclusion Criteria:\n\n* Pregnant women with disabilities such as deafness, serious mental illness, or mental retardation'}, 'identificationModule': {'nctId': 'NCT00121368', 'briefTitle': 'GN Tobacco Use Survey', 'organization': {'class': 'NETWORK', 'fullName': "NICHD Global Network for Women's and Children's Health"}, 'officialTitle': 'Survey on Tobacco Use in the GN Sites', 'orgStudyIdInfo': {'id': 'CP01 Tobacco Use'}}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Recife', 'country': 'Brazil', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'city': 'Quito', 'country': 'Ecuador', 'geoPoint': {'lat': -0.22985, 'lon': -78.52495}}, {'city': 'Guatemala City', 'country': 'Guatemala', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'city': 'Bhubaneswar', 'state': 'Odisha', 'country': 'India', 'geoPoint': {'lat': 20.27241, 'lon': 85.83385}}, {'city': 'Belagavi', 'country': 'India', 'geoPoint': {'lat': 15.85212, 'lon': 74.50447}}, {'city': 'Karachi', 'country': 'Pakistan', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Kinshasa', 'country': 'Republic of the Congo'}, {'city': 'Lusaka', 'country': 'Zambia', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Michele Bloch, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "NICHD Global Network for Women's and Children's Health", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': "Global Network for Women's and Children's Health Research", 'class': 'OTHER'}, {'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, {'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}, {'name': 'RTI International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}