Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT03464669
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2018-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impacts of Online and Group Perinatal Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064186', 'term': 'Prenatal Education'}], 'ancestors': [{'id': 'D010353', 'term': 'Patient Education as Topic'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Perinatal Knowledge', 'timeFrame': '10-20 weeks of pregnancy; 33 weeks of pregnancy', 'description': 'Measured with an adapted version of the Health Pregnancies Knowledge Survey'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Psychological Distress', 'timeFrame': '10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth', 'description': 'Measured with a validated French version of the 12-item General Health Questionnaire'}, {'measure': 'Change from Baseline Breastfeeding Self-Efficacy', 'timeFrame': '10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth', 'description': 'Assessed with a French version of the Breastfeeding Self-Efficacy Scale Short-Form'}, {'measure': 'Change from Baseline Anxiety', 'timeFrame': '10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth', 'description': 'Assessed with a validated French version of the State-Trait Anxiety Inventory'}, {'measure': 'Change from Baseline Self-Efficacy in the Parenting Role', 'timeFrame': '10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth', 'description': 'Assessed with a French version of the Parent Expectations Survey'}, {'measure': 'Change from Baseline Depression', 'timeFrame': '10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth', 'description': 'Assessed with a French version of the Parent Expectations Survey'}, {'measure': 'Concern about Labour and Birth', 'timeFrame': '6 weeks after child birth', 'description': 'Assessed with a French version of the Oxford Worries about Labour Scale'}, {'measure': 'Control during Childbirth', 'timeFrame': '6 weeks after child birth', 'description': 'Assessed with a French version of the Labour Agentry Scale'}, {'measure': 'Personal Control in Pain Relief during Childbirth', 'timeFrame': '6 weeks after child birth', 'description': 'Assessed with a French version of the Personal Control in Pain Relief Scale'}, {'measure': 'Birth Weight', 'timeFrame': '6 weeks after child birth', 'description': 'Self-reported by parents'}, {'measure': 'Personal experience of the COVID-19 crisis and its influence on the use of prenatal education and information services.', 'timeFrame': '33 weeks of pregnancy; 6 weeks after child birth', 'description': 'Measured by an in-house questionnaire put together by experts in perinatal care research and in the study of natural disasters and mental health.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnant Women and Partners']}, 'descriptionModule': {'briefSummary': "This project aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and users' health status.", 'detailedDescription': 'Prenatal education is a core component of perinatal care and services provided by health institutions. Whereas group prenatal education is the most common educational model, some health institutions have opted to implement online prenatal education to address accessibility issues as well as the evolving needs of future parents. This prospective cohort study aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and the perinatal health status of parents. It is part of a larger multipronged study using mixed methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pregnant women and partners.\n\nRecruitment methods :\n\n* By the research team in hospital waiting rooms, before ultrasound appointments\n* By health professionals in community centers during routine appointments\n* Posters with the team's contact information\n* Registration using advertisements on Facebook", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for pregnant women:\n\n* 10-20 weeks of pregnancy\n* Living within the targeted geographic territories\n* Fluent in French\n* Have not given birth previously\n\nInclusion criteria for partners:\n\n* Partner of pregnant women between 10 and 20 weeks of pregnancy\n* Living within the targeted geographic territories\n* Fluent in French\n\nExclusion Criteria:\n\n* Men and women not fulfilling inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03464669', 'briefTitle': 'Impacts of Online and Group Perinatal Education', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Impacts of Online and Group Perinatal Education: Towards and Optimization of Services', 'orgStudyIdInfo': {'id': 'PHE-148163'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group prenatal education', 'description': 'Prenatal education delivered in-person by health and social services centers', 'interventionNames': ['Other: Prenatal education']}, {'label': 'Online prenatal education', 'description': 'Online prenatal education provided or recommended by health and social services centers', 'interventionNames': ['Other: Prenatal education']}, {'label': 'Control group', 'description': 'Absence of prenatal education'}], 'interventions': [{'name': 'Prenatal education', 'type': 'OTHER', 'description': 'Observational study : natural distribution of participants between groups', 'armGroupLabels': ['Group prenatal education', 'Online prenatal education']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1L3L5', 'city': 'Québec', 'country': 'Canada', 'facility': 'CHU de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}