Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 6:30 AM
Study NCT ID:
NCT04328532
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2020-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Screening of Placenta Adhesion Abnormalities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective interventional clinical cohort study, monocentric, controlled, open.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 71}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-10-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the ROC curve of the T2 relaxation time mean value', 'timeFrame': 'Through study completion, an average of 6 months'}, {'measure': 'Area under the ROC curve of the T2* relaxation time mean value', 'timeFrame': 'Through study completion, an average of 6 months'}, {'measure': 'Area under the ROC curve of the Apparent Diffusion Coefficient mean value', 'timeFrame': 'Through study completion, an average of 6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta; Implantation']}, 'descriptionModule': {'briefSummary': 'Placenta Adhesion Abnormalities (PAA) are the consequence of an excessive invasion of the placenta within the myometrium. PAA are related to severe maternal pregnancy outcomes, especially in case of incidental discovery during delivery that increase the risk of intraoperative massive bleeding, hysterectomy and even maternal death. Ultrasound is the standard modality for diagnosing PAA, but Magnetic Resonance Imaging (MRI) has been increasingly performed in the case of inconclusive sonographic findings. However, standard morphological MRI sequences appear as insufficient to improve the sensitivity and specificity values for detecting PAA, while quantitative MRI may be more efficient.\n\nThe main objective of this study is to characterize the diagnostic performance of quantitative MRI parameters (mainly Apparent Diffusion Coefficient, T2 and T2\\*) reflecting placental perfusion and/or oxygenation at high field, without injection of gadolinium-based agent, for the detection of PAA in women with ongoing pregnancy between 30 and 38 weeks of gestation with risk factors for PPA.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant participant between 30 and 38 weeks of gestation,\n* Age ≥18 years old,\n* Participant who completed the preliminary medical examination,\n* Participant who has received full information about the organization of the research and has signed her informed consent.\n* Participant planning to give birth at CHRU of Nancy\n* Participant presenting risk factors for PAA : low-lying or covering placenta or in front of the uterine scar.\n\nExclusion Criteria:\n\n* Multiple pregnancy,\n* Participant presenting at least one contraindication or restriction to performing an MRI as described in the protocol, in accordance with the current recommendations,\n* Participant unable to understand or follow study procedure,\n* Person referred to in Articles L. 1121-6 to L. 1121-8, L1122-2 and L. 1122-1-2 of the Public Health Code.'}, 'identificationModule': {'nctId': 'NCT04328532', 'acronym': 'DIANE', 'briefTitle': 'MRI Screening of Placenta Adhesion Abnormalities', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'MRI Screening of Placenta Adhesion Abnormalities', 'orgStudyIdInfo': {'id': '2019-A02794-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregnancy with risk factors for PPA', 'interventionNames': ['Device: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'MRI examination (45 min max) with potential oxygen delivery for 10 min', 'armGroupLabels': ['Pregnancy with risk factors for PPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charline BERTHOLDT, MI', 'role': 'CONTACT', 'email': 'c.bertholdt@chru-nancy.fr', 'phone': '+33 3 83 34 43 12'}], 'facility': 'Centre Hospitalier Régional Universitaire de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Charline BERTHOLDT, MI', 'role': 'CONTACT', 'email': 'c.bertholdt@chru-nancy.fr', 'phone': '+33 3 83 34 43 12'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'BERTHOLDT Charline', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}