Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT04420169
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2020-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uniform Communication by Midwives in Preparation for an IVF Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'How do patients evaluate the communication by the midwife in anticipation of the IVF treatment cycle?', 'timeFrame': 'About 20 weeks counting from the launch of each questionnaire or earlier if the target of 50 patients is reached sooner', 'description': 'Self created questionnaire (no scale)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Communication', 'IVF']}, 'descriptionModule': {'briefSummary': 'Dutch-speaking women who are about to start an IVF treatment will be approached. If they are willing to participate in the study, they will receive an email with a link to an online questionnaire. This questionnaire will evaluate the communication by the midwive in preparation for an IVF treatment. When 50 women have completed the questionnaire a standardized communication protocol will be enrolled. Once all midwives are trained, 50 other IVF patients will be asked to complete the slightly adapted post questionnaire.The data from both questionnaires will be compared.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Dutch-speaking women who are about to start an IVF treatment at our department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women who are about to start an IVF treatment at our department\n\nExclusion Criteria:\n\n* non-Dutch speaking\n* women who are counseled by one of the midwives involved in the design of this study'}, 'identificationModule': {'nctId': 'NCT04420169', 'acronym': 'UNCOVeR', 'briefTitle': 'Uniform Communication by Midwives in Preparation for an IVF Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Uniform Communication by Midwives in Preparation for an IVF Treatment', 'orgStudyIdInfo': {'id': 'B670201627388'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PRE implementation communication protocol', 'interventionNames': ['Other: Questionnaire']}, {'label': 'POST implementation communication protocol', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'A digital questionnaire to evaluate the communication by midwives will be send out to IVF patients', 'armGroupLabels': ['POST implementation communication protocol', 'PRE implementation communication protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}