Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-26 @ 5:46 PM
Study NCT ID:
NCT07236060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Model to Help Differentiate Between Placenta Accreta Spectrum and Uterine Dehiscence in 3rd Trimester Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010921', 'term': 'Placenta Accreta'}], 'ancestors': [{'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'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Model for percise diagnosis of placenta accreta spectrum Using 2d and/or 3d ultrasound doppler to assess: Placental site', 'timeFrame': '(gestational age 28wk-full term) till operation'}, {'measure': 'Model for percise diagnosis of placenta accreta spectrum Using 2d and/or 3d ultrasound doppler to assess: placental thickness', 'timeFrame': '(gestational age 28wk- full term) till operation'}, {'measure': 'Model for percise diagnosis of placenta accreta spectrum Using 2d and/or 3d ultrasound doppler to assess: placental size', 'timeFrame': '(gestational age 28wk- fullterm) till operation'}, {'measure': 'Model for percise diagnosis of placenta accreta spectrum Using 2d and/or 3d ultrasound doppler to assess: placental lacunae', 'timeFrame': '(gestational age 28wk-full term) till operation'}, {'measure': 'Model for percise diagnosis of placenta accreta spectrum Using 2d and/or 3d ultrasound doppler to assess: Loss of placental hypoechoic zone', 'timeFrame': '(gestattional age 28wk-full term) till operation'}, {'measure': 'Model for percise diagnosis of placenta accreta spectrum Using 2d and/or 3d ultrasound doppler to assess: Mean systolic velocity in both uterine arteries', 'timeFrame': '(gestational age 28wks-full term) till time of operation'}, {'measure': 'Model for percise diagnosis of placenta accreta spectrum Using 2d and/or 3d ultrasound doppler to assess: Peak systolic velocity in uteroplacental interface', 'timeFrame': '(gestational age 28wks- full term) till operation'}, {'measure': 'Model for percise diagnosis of placenta accreta spectrum Using 2d and/or 3d ultrasound doppler to assess: Peak systolic velocity in uterovesical interface', 'timeFrame': '(gestational age 28wks- full term) ill operation'}], 'secondaryOutcomes': [{'measure': 'precise diagnosis of uterine dehiscence Using 2d and/or 3d ultrasound doppler to assess: Placental site', 'timeFrame': '(gestational age 28wk- fullterm) till operation'}, {'measure': 'precise diagnosis of uterine dehiscence Using 2d and/or 3d ultrasound doppler to assess: Placental size', 'timeFrame': '(gestational age 28wk- full term)till the operation'}, {'measure': 'precise diagnosis of uterine dehiscence Using 2d and/or 3d ultrasound doppler to assess: Placental thickness', 'timeFrame': '(gestational age 28wk-full term) till operation'}, {'measure': 'precise diagnosis of uterine dehiscence Using 2d and/or 3d ultrasound doppler to assess: Placental lacunae', 'timeFrame': '(gestational age 28wk- fullterm) till operation'}, {'measure': 'precise diagnosis of uterine dehiscence Using 2d and/or 3d ultrasound doppler to assess: Loss of placental hypoechoic zone', 'timeFrame': '(gestational age 28wks - fullterm) till operation'}, {'measure': 'precise diagnosis of uterine dehiscence Using 2d and/or 3d ultrasound doppler to assess: Mean systolic velocity in both uterine arteries', 'timeFrame': '(gestational age 28wk- fullterm) till operation'}, {'measure': 'precise diagnosis of uterine dehiscence Using 2d and/or 3d ultrasound doppler to assess: Peak systolic velocity in uteroplacental interface', 'timeFrame': '(gestational age 28wk- fullterm) till operation'}, {'measure': 'precise diagnosis of uterine dehiscence Using 2d and/or 3d ultrasound doppler to assess: Peak systolic velocity in uterovesical interface', 'timeFrame': '(gestational age 28wk-full term) till operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Placenta Accreta, Third Trimester', 'Uterine Scar Dehiscence']}, 'descriptionModule': {'briefSummary': 'By using 2d Ultrasound on 3rd trimester pregnant women, a model is made to help differentiate between placenta accreta spectrum and uterine scar dehiscence before operative action to help prepare multi-disciplinary steps if needed', 'detailedDescription': 'A cross-sectional observational study'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients admitted to women health hospital, Assiut university, Assiut', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women in 3rd trimester pregnancy with low lying placenta previa\n* History of 1 or more C-section\n* Patients planning to deliver baby in Assiut women health hospital\n* Willing and able to participate\n\nExclusion Criteria:\n\n* Antepartum Hemorrhage(sever attack) as it hinders time for accurate diagnosis and calling expert team of diagnosis'}, 'identificationModule': {'nctId': 'NCT07236060', 'briefTitle': 'Ultrasound Model to Help Differentiate Between Placenta Accreta Spectrum and Uterine Dehiscence in 3rd Trimester Pregnancies', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Placenta Accreta Spectrum VS Uterine Scar Dehiscence: Accurate Ultrasound Model in 3rd Trimester Pregnancies for Percise Diagnosis', 'orgStudyIdInfo': {'id': '042025201333'}}, 'armsInterventionsModule': {'interventions': [{'name': '2D ultrasound doppler', 'type': 'DEVICE', 'description': 'using 2d ultrasound doppler to form a model that will help distinguish between placenta accreta spectrum and uterine scar dehiscence pre-operatively'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa A Askalany', 'role': 'CONTACT', 'email': 'mostafaaskalany90@yahoo.com', 'phone': '+201022554284'}, {'name': 'Hassan s Kamel', 'role': 'CONTACT', 'email': 'kamelhs108@gmail.com', 'phone': '+201006664910'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Mostafa Ahmed Mohammed Refaat Askalany', 'investigatorAffiliation': 'Assiut University'}}}}