Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 7:11 PM
Study NCT ID:
NCT06114160
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014917', 'term': 'Whooping Cough'}], 'ancestors': [{'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recommendation of vaccination against pertussis', 'timeFrame': 'day0', 'description': "Knowledge of pregnant women's concerning recommendation of vaccination against pertussis from 20 to 36 weeks' gestation : does the woman know or not the recommandation concerning the vaccination"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cocooning strategy', 'pertussis', 'pregnancy', 'vaccination against pertussis'], 'conditions': ['Pertussis']}, 'descriptionModule': {'briefSummary': "In France, it has been recommended since 2022 that pregnant women be vaccinated against pertussis from 20 to 36 weeks' gestation.\n\nThis vaccination schedule is inspired by the Anglo-Saxon model and studies showing the effectiveness of this practice.\n\nThe aim of this vaccine is to protect the newborn by transferring antibodies from the fetus to the placenta, because Pertussis is a particularly serious disease in newborns.", 'detailedDescription': "The aim is to describe pregnant women's knowledge concerning pertussis, vaccination against pertussis during pregnancy and the cocooning strategy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant between 20 and 41 weeks of amenorrhea\n* Primiparous\n* aged more than 18\n* Agreed to participate in the study\n\nExclusion Criteria:\n\n* Multiparous\n* Protected by law (guardianship, guardianship, safeguarding of justice)\n* Not agreed to participate in this study'}, 'identificationModule': {'nctId': 'NCT06114160', 'acronym': 'Coqueluche-Vac', 'briefTitle': 'Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy', 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': 'Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy', 'orgStudyIdInfo': {'id': '2023_RIPH_015_Coqueluche-Vac'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pregnant women', 'description': 'Pregnant women between 20 and 41 weeks of amenorrhoea, primiparous.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data collection', 'armGroupLabels': ['pregnant women']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Barbe Coralie, DR', 'role': 'CONTACT', 'email': 'coralie.barbe@univ-reims.fr', 'phone': '0326913665', 'phoneExt': '+33'}, {'name': 'CURRS CURRS', 'role': 'CONTACT', 'email': 'curss@univ-reims.fr', 'phone': '0326918822', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Pilet Caroline, midwife', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Reims'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}