Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-01 @ 2:24 PM
Study NCT ID:
NCT06820892
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Information Provided During Antenatal Consultations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Question 8 of the questionnaire', 'timeFrame': 'The outcome is measured at the time of questionnaire completion, typically at hospital discharge or within one week post-discharge.', 'description': "In summary, did the information provided during the consultation with the paediatrician correspond to the events that transpired during your child's hospitalisation ? Patients are invited to indicate their level of agreement or disagreement with a series of four statements by selecting one of four options : 'not at all', 'to some extent', 'almost' or 'completely'."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antenatal', 'Antenatal consultation', 'information'], 'conditions': ['Congenital Anomalies', 'Prematurity', 'Antenatal Consultation']}, 'descriptionModule': {'briefSummary': 'The objective of this questionnaire study is to evaluate the concordance between the information provided to parents during antenatal consultations and their subsequent experiences following childbirth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Of the patients who were followed up at the multidisciplinary prenatal diagnosis centre and had an antenatal consultation with a pediatric neonatologist, 113 patients met the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were observed at the multidisciplinary prenatal diagnosis centre.\n* Patients who had attended at least one antenatal consultation with a pediatric neonatologist\n* Patients who gave birth between January 2020 and December 2022 and whose newborn was hospitalized in the neonatology department\n\nExclusion Criteria:\n\n* a child who died in hospital or had a condition with a high risk of death in the first few years of life\n* non-French speaking mothers\n* Mothers who were minors at the time of the study'}, 'identificationModule': {'nctId': 'NCT06820892', 'acronym': 'EVIDANCE', 'briefTitle': 'Quality of Information Provided During Antenatal Consultations', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of the Concordance Between the Information Delivered in Antenatal Diagnosis Consultation and Parents Experience After the Birth of Their Infant', 'orgStudyIdInfo': {'id': '24-5216'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients (mother only)', 'description': 'The patients were observed in a multidisciplinary prenatal diagnosis centre and subsequently delivered a newborn infant, who was then admitted to the neonatology department of the same hospital, between January 2020 and December 2022.', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'The study utilised a 16-item questionnaire to evaluate the quality of information received during antenatal diagnosis consultations and its congruence with subsequent experiences following birth and hospitalisation of the infant. The questionnaire encompassed seven questions pertaining to consultation arrangements, including duration, frequency and unit visits, six questions addressing the received information, and three questions exploring the long-term outcomes of the child.', 'armGroupLabels': ['Patients (mother only)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène GAUTHIER MOULINIER, MD', 'role': 'CONTACT', 'email': 'Helene.gauthier-moulinier@chu-lyon.fr', 'phone': '+33427855284'}], 'facility': 'Femme Mère Enfant Hospital (HFME)', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Cosima BABINET', 'role': 'CONTACT', 'email': 'cosima.babinet@chu-lyon.fr', 'phone': '+33608161034'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}