Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT07135635
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-22
First Post:
2025-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Middle Cerebral Artery Doppler( MCA-PSV) & Perinatal Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-14', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Third Trimester Middle Cerebral artery Doppler ( MCA -PSV).', 'timeFrame': '1 year'}, {'measure': 'Assess correlation between MCA Doppler indices and neonatal Hemoglobin level', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Assess correlation between MCA Doppler indices and neonatal weight.', 'timeFrame': '1 year'}, {'measure': 'Assess correlation between MCA Doppler indices and NICU admission.', 'timeFrame': '1 year'}, {'measure': 'Assess correlation between MCA Doppler indices and APGAR Score.', 'timeFrame': '1year'}, {'measure': 'Assess correlation between MCA Doppler indices and placental weight.', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Anemia During Pregnancy', 'Anemia Complicating Pregnancy', 'Anemia']}, 'descriptionModule': {'briefSummary': 'can we predict neonatal outcome by the results of 3rd trimester MCA Doppler Indices In pregnant women with anemia?? --- the aim of this study is to evaluate values of MCA Doppler indices in determining fetal outcome in pregnant women with anemia.', 'detailedDescription': 'This Cross\\_ sectional study will be performed At OBS/ GYN Department Sohag University Hospital for 1 year duration between February 2025 to February 2026.\n\nAll cases of pregnant women diagnosed with anemia at 3rd trimester will have baseline assessment of history, clinical examination, HB level, obstetric ultrasonography done then they will have Middle Cerebral Artery Doppler done to assess correlation between MCA Doppler indices \\& neonatal outcomes. Then appropriate treatment of anemia will be taken.\n\nDoppler indices and placental weight.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women with anemia in sohag university hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- (1) Pregnant women diagnosed with anemia at 3rd trimester with hemoglobin level ≤ 11 g/dl.\n\n(2) Singleton pregnancy.\n\nExclusion Criteria:\n\n1. Multifetal pregnancy.\n2. Fetal Anomalies.\n3. Any other maternal systemic diseases other than anemia as DM, Preeclampsia, Autoimmune disease.'}, 'identificationModule': {'nctId': 'NCT07135635', 'briefTitle': 'Middle Cerebral Artery Doppler( MCA-PSV) & Perinatal Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'The Value of Doppler Indices Of Middle Cerebral Artery For Prediction Of Fetal Outcome In Pregnant Women With Anemia', 'orgStudyIdInfo': {'id': 'Soh-Med-25-5-1 MD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Middle Cerebral Artery doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'All cases of pregnant women diagnosed with anemia at 3rd trimester will have baseline assessment of history, clinical examination, HB level, obstetric ultrasonography done then they will have Middle Cerebral Artery Doppler done to assess correlation between MCA Doppler indices \\& neonatal outcomes. Then appropriate treatment of anemia will be taken.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Faculty of Medicine- Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Yasser Ahmed professor of obstetrics & gynecology sohag university, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'sohag faculty of medecine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist at elhelal hospital for health insurance', 'investigatorFullName': 'Mahmoud Mohamed Mahmoud', 'investigatorAffiliation': 'Sohag University'}}}}