Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-03-28 @ 4:14 PM
Study NCT ID:
NCT04823104
Status:
TERMINATED
Last Update Posted:
2025-08-12
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'whyStopped': 'Due to recruitment and implementation difficulties, the study was stopped prematurely', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adequate pregnancy follow-up according to the French recommendations', 'timeFrame': '9 months', 'description': 'number of consultations, In all, 8 consultations should take place in a pregnancy that goes to term'}, {'measure': 'adequate pregnancy follow-up according to the French recommendations', 'timeFrame': '9 months', 'description': 'number of ultrasound exams, Three systematic or screening ultrasound examinations, one per trimester, are recommended'}, {'measure': 'adequate pregnancy follow-up according to the French recommendations', 'timeFrame': '9 months', 'description': 'number of biological exams of recommended laboratory tests for antenatal care'}], 'secondaryOutcomes': [{'measure': 'Adherence to antenatal care consultations of women', 'timeFrame': '9 months', 'description': 'Adherence to the applicable French regulations concerning the term and number of consultations that must be performed until delivery'}, {'measure': 'Adherence to antenatal care complementary exams of women by the mobile antenatal care clinic', 'timeFrame': '9 months', 'description': 'The performance of all of the recommended ultrasounds at the recommended dates and all of the mandatory or recommended laboratory tests for antenatal care'}, {'measure': 'adverse neonatal outcome', 'timeFrame': '9 months', 'description': 'prematurity, in utero death, small or large for gestational age, transfer in intensive unit'}, {'measure': 'adverse maternal outcome', 'timeFrame': '10 months', 'description': 'gestational hypertension, preeclampsia, gestational diabetes, post-partum hemmorage, maternal death, transfer in intensive unit'}, {'measure': 'economic analyse of the intervention', 'timeFrame': '24 months', 'description': 'cost of equipment, human resources, balanced to income inherent to the project in accordance with the standards of cost budget accounting by insurance perspective.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Home visitation', 'Isolated geographic area'], 'conditions': ['Pregnancy', 'Living in an Isolated Area']}, 'referencesModule': {'references': [{'pmid': '36797021', 'type': 'DERIVED', 'citation': "Debost-Legrand A, Legrand G, Duclos-Medard J, Thomazet J, Pranal M, Langlois E, Mourgues C, Vendittelli F. Opti'care protocol: a randomised control trial to evaluate the impact of a mobile antenatal care clinic in isolated rural areas on prenatal follow-up. BMJ Open. 2023 Feb 16;13(2):e060337. doi: 10.1136/bmjopen-2021-060337."}]}, 'descriptionModule': {'briefSummary': 'Pregnant women who live in rural area have fewer prenatal consultations. It has been demonstrated that maternal and neonatal morbidity and mortality increase if time travel to a maternity ward is longer than 30 min.\n\nHome visitation in isolated area may improve prenatal follow-up as it gives full access to women to health care professionals as well as biological and ultrasound exams without travelling.\n\nOur aim is to assess the impact of home visitation on prenatal follow-up as compared to prenatal follow-up in maternity ward and in primary care.\n\nIsolated areas will be randomized, for women living in areas included in the intervention group, home visitations will be planned for prenatal follow-up. Ultrasound screening as well as blood exams will be performed during home visitations. For women living in control areas, they will be free to choose prenatal follow-up modalities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At the first antenatal consultation, confirming the pregnancy.\n* Pregnant women who live in an area of geographic vulnerability covered by a perinatal network\n* The women must be informed about the study, understand, read, and speak French, and must be able to consent to participate in medical research\n\nExclusion Criteria:\n\n* Pregnant women who live outside an area of geographic vulnerability covered by a perinatal network\n* Women who give birth in a maternity ward outside Auvergne\n* Women from another region giving birth in a maternity ward in Auvergne'}, 'identificationModule': {'nctId': 'NCT04823104', 'acronym': "OPTI'SOINS", 'briefTitle': 'Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health Network', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health', 'orgStudyIdInfo': {'id': 'PREPS 2019 DEBOST-LEGRAND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group with home visitation', 'description': 'pregnant women who are included in this group will be assigned an intervention by home visitation for pregnancy follow-up', 'interventionNames': ['Other: Home visitation']}, {'type': 'NO_INTERVENTION', 'label': 'control group without home visitation', 'description': 'pregnant women will be free to choose their pregnancy follow-up without home visitation'}], 'interventions': [{'name': 'Home visitation', 'type': 'OTHER', 'description': 'Home visitation for pregnancy follow-up', 'armGroupLabels': ['Intervention group with home visitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'AURA', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}