Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT04264234
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2018-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}], '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': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Placenta previa cases will be followed up at 28th gestational week and evaluated at 32nd week by vaginal ultrasonography and MRI and this follow-up will continue until delivery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2018-11-03', 'studyFirstSubmitQcDate': '2020-02-09', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of placental invasion pathologies', 'timeFrame': '1 day', 'description': 'Placental invasion pathologies detected during delivery will be evaluated.'}, {'measure': 'The number of preterm birth', 'timeFrame': '1 day', 'description': 'The relation between preterm birth and placental invasion pathologies will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['placenta previa', 'placental invasion anomalies', 'timing of the birth'], 'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': "Placenta previa cases are one of the difficult groups of patients to manage in modern obstetrics. When the literature is evaluated extensively, no clear information can be seen especially in terms of hospitalization time. Inpatient follow-up of this patients has negative effects like hospital infections in terms of the patient, workload in terms of health personnel and financial losses in terms of the country's economy. Placenta previa cases are complicated patients in which generalizations cannot be easily performed and they should be monitored at third level hospitals. In addition, care should be personalized considering the many reasons. In this study, placenta previa cases will be followed up at 28th gestational week and evaluated at 32nd week by vaginal ultrasonography and MRI and this follow-up will continue until delivery. Thus, in this study, it was aimed to determine the parameters that would allow systematic personalization of health service in this particular patient group by making risk assessment of placenta previa cases."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Pregnant participant', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Monitoring of placenta previa\n* To apply before the 28th week\n* To have a low-risk second trimester screening test\n* No malformation detected in the anomaly screening\n\nExclusion Criteria:\n\n* Multiple pregnancies\n* Pregnancy complicated with preeclampsia\n* Pregnancy complicated by gestational hypertension\n* Pregnancy complicated by gestational diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT04264234', 'briefTitle': 'Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria', 'orgStudyIdInfo': {'id': '18-9.1/27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placenta Previa', 'description': 'Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography and MRI.', 'interventionNames': ['Diagnostic Test: Vaginal Ultrasonography', 'Diagnostic Test: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Vaginal Ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography for invasion anomaly and preterm birth.', 'armGroupLabels': ['Placenta Previa']}, {'name': 'Magnetic Resonance Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Placenta previa cases will be evaluated at 32nd week by MRI for invasion anomaly and preterm birth.', 'armGroupLabels': ['Placenta Previa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Sabahattin a Arı, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sabahattin Anıl Arı', 'investigatorAffiliation': 'Ege University'}}}}