Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-02 @ 1:51 AM
Study NCT ID:
NCT04938050
Status:
UNKNOWN
Last Update Posted:
2022-12-08
First Post:
2021-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-18', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign)', 'timeFrame': 'June 2021- July 2022'}, {'measure': 'Accuracy of our specialized pro forma in assessing extent of morbidly adherent placenta(focal , diffuse)', 'timeFrame': 'June 2021- July 2022'}, {'measure': 'Accuracy of our specialized pro forma in assessing depth of invasion of placenta accreta spectrum (accrete, increta and percreta)', 'timeFrame': 'June 2021- July 2022'}], 'secondaryOutcomes': [{'measure': '1- Correlation between US signs and intraoperative findings including morbidity and mortality', 'timeFrame': 'June 2021- July 2022'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Morbidly Adherent Placenta']}, 'descriptionModule': {'briefSummary': 'This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '28 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '21 pregnant females during their late 3rd trimester between (34 0/7: 37 0/7 weeks gestation)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group 28:42 years.\n* Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks).\n* With a single living fetus in the current pregnancy.\n* A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation)\n* Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.\n\nExclusion Criteria:\n\n* Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta.\n* Maternal chronic medical disorders( diabetes mellitus, hypertension)\n* Patients presented with severe attack of bleeding.\n* Patients presented with rupture of membrane.\n* Emergency delivery regardless the cause.'}, 'identificationModule': {'nctId': 'NCT04938050', 'briefTitle': 'Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings', 'orgStudyIdInfo': {'id': '23-2021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound evaluation, with grayscale and color Doppler imaging.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hassan Gaafar, M.D.', 'role': 'CONTACT', 'email': 'hassangaafar@kasralainy.edu.eg', 'phone': '01224022330'}], 'facility': 'Cairo university Kasr Alainy OBGYN hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Fatma Fathy Hafez Ismail', 'investigatorAffiliation': 'Cairo University'}}}}