Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-27 @ 5:34 AM
Study NCT ID:
NCT01974050
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mss2112@cumc.columbia.edu', 'phone': '212-342-5732', 'title': 'Melissa S. Stockwell', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Text Message Monitoring', 'description': 'Use of text messaging to monitor post-vaccination\n\nText message surveillance', 'otherNumAtRisk': 166, 'otherNumAffected': 0, 'seriousNumAtRisk': 166, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Message Monitoring', 'description': 'Use of text messaging to monitor post-vaccination\n\nText message surveillance'}], 'classes': [{'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Number of eligible pregnant women \\<20 weeks gestational age who receive IIV who will be willing to enroll in a text messaging-based vaccine adverse event monitoring program', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Message Monitoring', 'description': 'Use of text messaging to monitor post-vaccination\n\nText message surveillance'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'on vaccination day and the next 2 days (D0-2)', 'description': 'Number of enrollees who text temperature-related information for the d0-2 period post-vaccination', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Message Monitoring', 'description': 'Use of text messaging to monitor post-vaccination\n\nText message surveillance'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months', 'description': 'Feasibility of text messaging to monitor pregnancy outcomes through the end of pregnancy: Number of women enrollees who continue to text pregnancy-related outcomes through the end of their pregnancy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With a Fever in Days 0 to 2 Post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Message Monitoring', 'description': 'Use of text messaging to monitor post-vaccination\n\nText message surveillance'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 days', 'description': 'Number of participants with any fever on days 0 to 2 post-vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pregnancy Complication', 'timeFrame': '9 months', 'description': 'Problems reported during pregnancy', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pregnancy Outcome', 'timeFrame': '9 months', 'description': 'Pregnancy outcome including termination, preterm birth, term birth or stillbirth', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Text Message Monitoring', 'description': 'Use of text messaging to monitor post-vaccination\n\nText message surveillance'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Text Message Monitoring', 'description': 'Use of text messaging to monitor post-vaccination\n\nText message surveillance'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '19-25 years', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': '26-34 years', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}, {'title': '35-46 years', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '166', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Indigenous Latin American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2013-10-28', 'resultsFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2013-10-28', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-04', 'studyFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With a Fever in Days 0 to 2 Post-vaccination', 'timeFrame': '2 days', 'description': 'Number of participants with any fever on days 0 to 2 post-vaccination'}, {'measure': 'Pregnancy Complication', 'timeFrame': '9 months', 'description': 'Problems reported during pregnancy'}, {'measure': 'Pregnancy Outcome', 'timeFrame': '9 months', 'description': 'Pregnancy outcome including termination, preterm birth, term birth or stillbirth'}], 'primaryOutcomes': [{'measure': 'Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age', 'timeFrame': '3 months', 'description': 'Number of eligible pregnant women \\<20 weeks gestational age who receive IIV who will be willing to enroll in a text messaging-based vaccine adverse event monitoring program'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV', 'timeFrame': 'on vaccination day and the next 2 days (D0-2)', 'description': 'Number of enrollees who text temperature-related information for the d0-2 period post-vaccination'}, {'measure': 'Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy', 'timeFrame': '9 months', 'description': 'Feasibility of text messaging to monitor pregnancy outcomes through the end of pregnancy: Number of women enrollees who continue to text pregnancy-related outcomes through the end of their pregnancy'}]}, 'conditionsModule': {'keywords': ['Influenza vaccination'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '28495223', 'type': 'RESULT', 'citation': 'Stockwell MS, Cano M, Jakob K, Broder KR, Gyamfi-Bannerman C, Castano PM, Lewis P, Barrett A, Museru OI, Castellanos O, LaRussa PS. Feasibility of Text Message Influenza Vaccine Safety Monitoring During Pregnancy. Am J Prev Med. 2017 Sep;53(3):282-289. doi: 10.1016/j.amepre.2017.03.014. Epub 2017 May 8.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/28495223', 'label': 'PubMed link'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will prospectively assess fever rates and other adverse events in pregnant women after administration of inactivated influenza vaccine (IIV) using text messaging. The investigators hypothesize that women \\<20 weeks gestational age who receive IIV will be willing to enroll in a text messaging-based vaccine adverse event monitoring program and will use it to report fever in the post-vaccination period as well as continue to text pregnancy-related outcomes through the end of their pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Are pregnant with a gestational age of \\<20 weeks either by last menstrual period (LMP) and/or ultrasound\n2. Are at least 18 years of age\n3. Have a visit at a study site during the enrollment period\n4. Receive IIV at that visit\n5. Have a cell phone with text messaging capabilities\n6. Are English or Spanish-speaking\n7. Are willing to report via text message through end of pregnancy\n\nExclusion Criteria:\n\n1. Decision to not continue with pregnancy\n2. Any contraindication to receipt of inactivated influenza vaccines\n3. Receipt LAIV (live attenuated influenza vaccine) at that visit\n4. Previous receipt of IIV in this pregnancy\n5. Presence of fever \\>=100.4F at time of vaccination;\n6. Administration of any antipyretic in the 6-hour period prior to vaccination,\n7. Stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever;\n8. Patient only speaks a language other than English or Spanish\n9. Patient does not have a cell phone with text messaging\n10. Patient's inability to read text messages"}, 'identificationModule': {'nctId': 'NCT01974050', 'briefTitle': 'PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'PregText: Assessing the Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging', 'orgStudyIdInfo': {'id': 'AAAM4906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Text message monitoring', 'description': 'Use of text messaging to monitor post-vaccination', 'interventionNames': ['Behavioral: Text message surveillance']}], 'interventions': [{'name': 'Text message surveillance', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Text message monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Melissa Stockwell, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Philip LaRussa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Maria Cano, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics and Population and Family Health', 'investigatorFullName': 'Melissa Stockwell', 'investigatorAffiliation': 'Columbia University'}}}}