Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-03-13 @ 4:32 PM
Study NCT ID:
NCT01872156
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2013-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-11', 'studyFirstSubmitDate': '2013-04-24', 'studyFirstSubmitQcDate': '2013-06-06', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of abstinence of tobacco', 'timeFrame': '6 months', 'description': 'Rate of abstinence of tobacco to 20-28 weeks of childbearing , to 36-38 weeks and to 6 postpartum (post-childbearing) months. The abstinence will be validated for cooximetry.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking', 'Primary care'], 'conditions': ['Cessation, Smoking']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://gestabac.wordpress.com', 'label': 'An online platform to facilitate communication and dissemination of information between the research group'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of the behavior treatment accompanied by self-help materials in Primary health care, across the intervention of the midwifes in the pregnancy follow-up visits.', 'detailedDescription': 'Aim: To evaluate the efficiency of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on tobacco abstinence at the conclusion of the pregnancy self referred and validated with cooximetry.\n\nSecondary objectives:\n\n1. To evaluate the effectiveness of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on the tobacco abstinence 6 months after the childbirth.\n2. The effectiveness of the intervention values on the weight of the newborn child, the number of childbirths pre-term and the perinatal mortality.\n3. To study the effectiveness of the intervention in smoking on the maintenance of the breast-feeding to 3 and 6 months.\n\nMethod:\n\nDesign: cluster randomized controlled trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service.\n\nSample size adjusted for design effect: number of smoking women in every branch would be of 350.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* pregnant at 20 weeks or less of gestation\n* attending her first prenatal visit with any of the participating prenatal care teams (this first prenatal visit takes place usually around 6-12 weeks of pregnancy)\n* defining herself as a current cigarette smoker or recent ex-smoker (see below for a definition of these terms)\n* being able to meet the requisites of the trial:\n* being available for the next 15 months\n* defining herself as fluent in reading and speaking Spanish to understand the study procedures and to comply with them\n\n * meeting no exclusion criterion; and\n * willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* communication barrier;\n* active addictions to other psychoactive substances\n* involved in any other formal smoking cessation program or in another trial during the study period; or\n* does not consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT01872156', 'acronym': 'GESTABAC', 'briefTitle': 'Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gerencia de Atención Primaria, Madrid'}, 'officialTitle': 'Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'SOMAMFYC11/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention GESTABAC', 'description': 'Intervention based on the "Clinician\'s Guide to helping Pregnant Women Quit Smoking" on the rates of abstinence of the patients in whom it has been controlled in this period of time, at the end of the pregnancy and after the childbirth.', 'interventionNames': ['Other: Intervention GESTABAC']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'The group control will act according to usual management.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Intervention GESTABAC', 'type': 'OTHER', 'description': 'Intervention based on the "Clinician\'s Guide to helping Pregnant Women Quit Smoking" on the rates of abstinence of the patients in whom it has been controlled in this period of time, at the end of the pregnancy and after the childbirth.', 'armGroupLabels': ['Intervention GESTABAC']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'The group control will act according to usual management.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28850', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Gerencia de Atención Primaria', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Encarnación Serrano-Serrano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gerencia de Atención Primaria, Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gerencia de Atención Primaria, Madrid', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}