Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02699632
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2016-01-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Participate While Pregnant Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Leanne.Redman@pbrc.edu', 'phone': '2257630947', 'title': 'Leanne Redman, Principal Investigator', 'organization': 'Pennington Biomedical Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Completeness checks were not used.'}}, 'adverseEventsModule': {'description': 'Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Willingness to Participate in Research While Pregnant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Respondents were asked what types of research they were willing to participate in during pregnancy'}], 'classes': [{'title': 'Observational Studies', 'categories': [{'title': 'Yes', 'measurements': [{'value': '319', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Retrospective Studies', 'categories': [{'title': 'Yes', 'measurements': [{'value': '288', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Lifestyle Interventions in Pregnancy', 'categories': [{'title': 'Yes', 'measurements': [{'value': '308', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Survey question: What types of research would you be willing to participate in while you were pregnant?', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'part 1 of question observational studies; part 2 of question retrospective studies; part 3 of question lifestyle interventions in pregnancy'}, {'type': 'SECONDARY', 'title': 'Preferred Methods for Learning About a Research Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Survey respondents were asked how they would prefer to learn about a research study'}], 'classes': [{'categories': [{'title': 'In person by my health care provider', 'measurements': [{'value': '222', 'groupId': 'OG000'}]}, {'title': "in person by someone I didn't know", 'measurements': [{'value': '130', 'groupId': 'OG000'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Survey respondents were asked how they would prefer to learn about a research study with several answers cited.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comfort of Participating in Research While Pregnant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Survey respondents were asked about their comfort and whether or not their physician needed to be involved.'}], 'classes': [{'categories': [{'title': 'Yes- if my physician approved', 'measurements': [{'value': '222', 'groupId': 'OG000'}]}, {'title': 'Other', 'measurements': [{'value': '136', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Survey question: Would you feel comfortable participating in a research study while pregnant?', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concerns for Participating in Research While Pregnant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Survey respondents were asked about their concerns and what could be done to help minimize those concerns.'}], 'classes': [{'categories': [{'title': "physician's approval would ease concerns", 'measurements': [{'value': '233', 'groupId': 'OG000'}]}, {'title': 'other', 'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Survey question: What concerns might make you hesitant to participate in a research study while pregnant?', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'The survey was taken by 360 women previously, currently, or planning to become pregnant.\n\nAlthough number of unique site visitors between January and June 2016 is indeterminable, we had a completion rate of 69% (the percentage of surveys completed out of the total number initiated, ie, number of page 2 completions and number of page 1 completions).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '358'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Women previously, currently, or planning to become pregnant. Data utilized is from completed questionnaires only, is uncorrected, and was collected from January through June 2016.\n\nMode of initial contact with potential participants was made on the Internet (email and Facebook posts). Participants were instructed of survey length in these Internet advertisements and study purpose and data storage information on the first page of our electronic survey.\n\nNo incentives were offered to participants, no protected health information was collected, and no measures were used for prevention of multiple entries from the same individual.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-20 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '21-25 years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}, {'title': '26-30 years', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}]}]}, {'title': '31-45 years', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}]}]}, {'title': '>45 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '360', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '286', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '360', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2016-01-21', 'resultsFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2016-02-29', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-09', 'studyFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Willingness to Participate in Research While Pregnant', 'timeFrame': 'Day 1', 'description': 'Survey question: What types of research would you be willing to participate in while you were pregnant?'}], 'secondaryOutcomes': [{'measure': 'Preferred Methods for Learning About a Research Study', 'timeFrame': 'Day 1', 'description': 'Survey respondents were asked how they would prefer to learn about a research study with several answers cited.'}, {'measure': 'Comfort of Participating in Research While Pregnant', 'timeFrame': 'Day 1', 'description': 'Survey question: Would you feel comfortable participating in a research study while pregnant?'}, {'measure': 'Concerns for Participating in Research While Pregnant', 'timeFrame': 'Day 1', 'description': 'Survey question: What concerns might make you hesitant to participate in a research study while pregnant?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Survey'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '28178062', 'type': 'DERIVED', 'citation': 'Sutton EF, Cain LE, Vallo PM, Redman LM. Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials. Obstet Gynecol. 2017 Mar;129(3):554-559. doi: 10.1097/AOG.0000000000001900.'}]}, 'descriptionModule': {'briefSummary': 'The main goal for this study is to assess concerns and barriers to research participation by pregnant women through an anonymous online survey (www.pbrc.edu/ParticipateWhilePregnantSurvey).', 'detailedDescription': 'Participants will complete an online survey distributed through HIPAA compliant REDCap database. Collected data will consist of general multiple choice responses and optional "write-in" responses (e.g. providing a personal response for elaboration an "Other" option). No private health information will be collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited online. Anyone can take this survey, however females who have been pregnant or are planning to become pregnant will be the most relevant population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any individual may complete this survey.'}, 'identificationModule': {'nctId': 'NCT02699632', 'briefTitle': 'Participate While Pregnant Survey', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Research Participation in the Pregnant Population: A Survey Study', 'orgStudyIdInfo': {'id': 'PBRC 2015-068'}}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Leanne M Redman, PhD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leanne Redman', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}