Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01248520
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2010-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influenza and Text Messaging in Pregnancy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2010-11-23', 'studyFirstSubmitQcDate': '2010-11-23', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake.', 'timeFrame': 'at participant post-partum visit', 'description': 'To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. We hypothesize that text messaging will improve the timing (earlier in flu season) and rate of receipt of influenza vaccination in pregnancy.'}], 'secondaryOutcomes': [{'measure': 'To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy.', 'timeFrame': 'at participant post-partum visit', 'description': "To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy. We hypothesize that women receiving text messages will be more likely than controls to have accurate knowledge about pregnant women's increased susceptibility to influenza and about the vaccine's safety and efficacy in pregnancy."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Influenza Vaccination'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '23635672', 'type': 'DERIVED', 'citation': 'Moniz MH, Hasley S, Meyn LA, Beigi RH. Improving influenza vaccination rates in pregnancy through text messaging: a randomized controlled trial. Obstet Gynecol. 2013 Apr;121(4):734-740. doi: 10.1097/AOG.0b013e31828642b1.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.', 'detailedDescription': 'History and the 2009 H1N1 influenza pandemic suggest that both seasonal and pandemic influenza infections impart disproportionate morbidity and mortality among gravidas. The influenza vaccine represents a viable, preventive health intervention to mitigate disease burden for gravidas and their neonates. Despite the safety and efficacy of influenza vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide. Barriers to influenza vaccination during pregnancy include patient concerns about vaccine safety and unappreciated risk of influenza infection. Cellular phone text messaging has emerged as an innovative technology with advantages of ubiquity, rapid, confidential information transmission, and low cost. Text messaging may represent an effective way to educate pregnant women about their particular vulnerability to influenza infection and enhance influenza vaccine uptake. We propose a randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pregnant women less than 28 weeks estimated gestation age\n2. Between 14-50 years of age\n3. Willing to provide informed consent and undergo necessary study procedures\n\nExclusion Criteria:\n\n1. Unwillingness or inability to receive text messages\n2. Receipt of the current season's influenza vaccine or plan to receive the influenza vaccine on the day of the enrollment visit\n3. Reported history of adverse reaction precluding receipt of the vaccine\n4. Unwillingness or inability to provide informed consent and comply with study criteria."}, 'identificationModule': {'nctId': 'NCT01248520', 'briefTitle': 'Influenza and Text Messaging in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Text Messaging For Preventative Health During Pregnancy; Improving Influenza Vaccination Rates In Pregnancy: A Randomized Controlled Trial of Text Messaging to Increase Vaccine Uptake', 'orgStudyIdInfo': {'id': 'PRO09100504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'General health information', 'description': 'Pregnant women receiving text messages containing general health messages without including information regarding the importance of the influenza vaccination', 'interventionNames': ['Other: general health information']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Influenza and general health information', 'description': 'Pregnant women receiving text messages with influenza facts and the importance of the influenza vaccination, as well as general health messages Intervention: Text messages with influenza facts', 'interventionNames': ['Other: influenza and general health information']}], 'interventions': [{'name': 'influenza and general health information', 'type': 'OTHER', 'description': 'Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver. These messages will contain general health information as well as information regarding influenza and the importance of vaccination during pregnancy.', 'armGroupLabels': ['Influenza and general health information']}, {'name': 'general health information', 'type': 'OTHER', 'description': 'Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.', 'armGroupLabels': ['General health information']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Michelle Moniz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Richard Beigi', 'investigatorAffiliation': 'University of Pittsburgh'}}}}