Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT04020432
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2019-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Knowledge Assessment of Women About Pictograms Associated With the Danger of Medicines Taken During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2019-07-12', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication pictogram women knowledge measure', 'timeFrame': 'day 0', 'description': 'Determination of women knowledge about pictograms associated with the danger of certain medicines during pregnancy by analysing the questionnaire responses'}], 'secondaryOutcomes': [{'measure': 'Medication pictogram women information measure', 'timeFrame': 'day 0', 'description': 'Determination of women information about pictograms associated with the danger of certain medicines during pregnancy by analysing the questionnaire responses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knowledge', 'medicine', 'pictogram', 'pregnant woman', 'childbearing age woman'], 'conditions': ['Knowledge, Attitudes, Practice', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Women\'s awareness about the danger of certain medicines taken during pregnancy presents a real public health issue. To enhance awareness and information for women and healthcare professionals, new pictograms " pregnant women " appeared on medication boxes, on October 16, 2017. These new pictograms can change women\'s perception of self-medication during pregnancy and of the danger of taking certain medicines for the unborn development. Furthermore, the investigators can wonder if the meaning of these pictograms is well understood. Therefore, the study\'s primary aim is to assess the knowledge of pregnant or childbearing age women about the pictograms associated with the danger of certain medicines taken during pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant or childbearing age women between 18 and 45 years old.', 'genderDescription': 'this study is includying only pregnant and childbearing age women', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women who agree to participate to the study\n* women who understand french language (oral and written)\n* pregnant women and women of childbearing age from 18 to 45 years old.\n\nExclusion Criteria:\n\n* Women who have already answered the questionnaire\n* women who don't want to answer the questionnaire\n* women who don't understand french language\n* women who are under the age of 18 or over the age of 45"}, 'identificationModule': {'nctId': 'NCT04020432', 'acronym': 'ECOFP', 'briefTitle': 'Knowledge Assessment of Women About Pictograms Associated With the Danger of Medicines Taken During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Knowledge Assessment of Pregnant or Childbearing Age Women About Pictograms Associated With the Danger of Certain Medicines Taken During Pregnancy.', 'orgStudyIdInfo': {'id': 'PI2018_843_0042'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pregnant women', 'description': "Pregnant women are coming to their monthly consultation. A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators.\n\nPregnant women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally.", 'interventionNames': ['Behavioral: questionary']}, {'label': 'childbearing age women', 'description': "Women of childbearing age, who are coming for a gynecological consultation. A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators.\n\nChildbearing age women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally.", 'interventionNames': ['Behavioral: questionary']}], 'interventions': [{'name': 'questionary', 'type': 'BEHAVIORAL', 'description': "A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators.\n\nWomen can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally.", 'armGroupLabels': ['childbearing age women', 'pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Alice Rousseaux', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Hirson'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier HIRSON', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}