Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT01233804
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2010-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opting In vs Opting Out
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2010-10-27', 'studyFirstSubmitQcDate': '2010-11-01', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccination rates', 'timeFrame': 'time 0 of part one study visit', 'description': 'Vaccination rates will be analyzed for the two groups (opting in vs opting out) to determine group vaccination rate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['influenza vaccination rates'], 'conditions': ['Influenza Vaccination']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare methods for consenting (opting in vs opting out) on influenza vaccine uptake rate in pregnant women. This study is designed to learn about the impact of influenza vaccination in pregnant women. This study will help gather knowledge about influenza vaccine side effects (if given) and whether the vaccine reduces the number of respiratory infection in mothers and their infants.', 'detailedDescription': 'Pregnant women who present for routine prenatal care when influenza vaccine is available would be eligible. Enrolled women would be randomized to either the Opting in (obtaining written consent to administer the vaccine) or Opting out (signing only to refuse the vaccine) study group (Part 1). Vaccine uptake rate and reason for refusal will be captured for enrollees. At the end of this clinic visit, enrollees will be asked if they are interested in participating in Part 2 and 3 of the study. If yes, consent will be obtained. Part 2 of the study, a random sample of 50 women will be called 2 days after enrollment to determine 1) vaccine side effects 2) recall of information provided in consent and 3) to confirm next followup visit with Obstetrician. During Part 3, at 6 weeks post EDD (estimated due date), data about episodes of respiratory illness in the mothers and their infants occuring between the time when influenza vaccine was offered (Part 1) and 6 weeks post-EDD will be abstracted using a standard form. Data will be collected retrospectively by research nurses.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant female age \\>17 years\n* presenting for routine PNC at UT Houston or UT Galveston\n* pregnant during influenza season\n* pregnant when influenza vaccine available\n\nExclusion Criteria:\n\n* influenza vaccine contraindication'}, 'identificationModule': {'nctId': 'NCT01233804', 'briefTitle': 'Opting In vs Opting Out', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Opting In vs Opting Out: Impact on Influenza Vaccination in Pregnant Women', 'orgStudyIdInfo': {'id': 'HSC-MS-10-0557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Opting in', 'description': 'Currently, pregnant women have to sign a consent stating that they want the influenza vaccine (at the clinics where the study is being conducted). Therefore, this group is the same as usual care. However, women will then be asked if they would like to take part in parts 2 and 3 of the study.'}, {'type': 'EXPERIMENTAL', 'label': 'Opting Out', 'description': 'Women will sign a consent form only if they do not want to receive the flu vaccine.', 'interventionNames': ['Other: Opting Out']}], 'interventions': [{'name': 'Opting Out', 'type': 'OTHER', 'description': 'Usual care is for pregnant women to sign a consent to get the influenza vaccine. The intervention is to offer a group of women the option to sign only when they refuse the influenza vaccine.', 'armGroupLabels': ['Opting Out']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': "University of Texas Medical Branch, Women's Clinics", 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston, Professional Building', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Susan H Wootton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilstrap, Larry C, M.D.', 'class': 'INDIV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assitant Professor - Ctr For Clnc Rsrch & Evidnc MD', 'investigatorFullName': 'Susan Wootton', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}