Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 1:31 AM
Study NCT ID:
NCT06356493
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010921', 'term': 'Placenta Accreta'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-30', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'calculated blood loss', 'timeFrame': 'peroperatively', 'description': 'The blood losses were calculated by weighing the surgical drapes and compresses and quantifying the aspirated bleeding'}, {'measure': 'Transfusion peroperatively', 'timeFrame': 'First 24 hours]', 'description': 'peroperatively'}, {'measure': 'Duration of surgery', 'timeFrame': 'peroperatively', 'description': 'MINUTES'}, {'measure': 'Postoperative hospital stay', 'timeFrame': 'up to 40 days postpartum', 'description': 'DAYS'}, {'measure': 'Postoperative transfer to the intensive care unit', 'timeFrame': 'up to 40 days postpartum', 'description': 'NUMBER'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'time from surgery up to 30 days postoperative', 'description': 'surgical site infection, bladder injury, need for surgical revision, and pulmonary embolism'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['haemorrhage', 'Placenta accreta spectrum disorder', 'caesarean hysterectomy', 'occlusion balloons', 'internal iliac artery'], 'conditions': ['Hemorrhage', 'Placenta Accreta Spectrum', 'Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons.\n\nThe aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders.', 'detailedDescription': 'Study population:\n\nIn the study, the population was divided into two groups:\n\nGroup1: Patients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries.\n\nGroup2: Patients treated by caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries.\n\nService Protocol:\n\nAll patients received dexamethasone for foetal lung maturation. Preoperative placement of prophylactic occlusion balloons of both internal iliac arteries (OBIIA) was performed at radiology department. Access to the internal iliac arteries was achieved by retrograde transcutaneous introduction of hydrophilic sheath kits of 8.5 mm under fluoroscopic guidance from both femoral arteries. Once in the lumens of the two internal iliac arteries, the radiologist inflated the balloons until blood flow ceased. The pressure at which occlusion of both internal iliac arteries was achieved was recorded for subsequent replication in the operating room. The radiologist secured the two kits to the skin and applied a compressive dressing. The patient was then directly transferred to the operating room.\n\nGeneral anaesthesia was preferred. Blood loss was estimated by weighing surgical sponges and drapes and quantifying aspirated blood.\n\nInitially, a JJ stent was inserted for both groups to limit urinary tract injuries. Caesarean hysterectomy was performed through a midline infraumbilical incision. The bladder-uterine peritoneum was dissected, followed by a vertical fundal hysterotomy away from the placenta, and the foetus was delivered. Inflation of the occlusion balloons of both internal iliac arteries was performed simultaneously with extraction by the radiologist. This was followed by clamping the umbilical cord and closure of the hysterotomy while leaving the placenta in situ without any attempt at traction or delivery and without oxytocin administration.\n\nthe surgeon proceeded with the remaining steps of hysterectomy. The radiologist deflated the balloons at the end of the hysterectomy. The inflation of the OBIIA did not exceed 60 minutes. Haemostasis was verified, and an intraperitoneal drainage system was installed. A video was developed summarizing the procedure in Group 2.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We collected 38 patients who were divided into two groups: Group 1 (n=22), Group 2 (n=16).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* placenta accreta spectrum disorder (PASD) confirmed by histopathological examination.\n* caesarean hysterectomy.\n\nExclusion Criteria:\n\n* placenta accreta suspected in MRI fundings but disproved in in histopathological examination.\n* conservative treatment of PASD'}, 'identificationModule': {'nctId': 'NCT06356493', 'briefTitle': 'Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD', 'organization': {'class': 'OTHER', 'fullName': 'Tunis University'}, 'officialTitle': 'Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for Placenta Accreta Spectrum Disorder Reduces Blood Loss: a Retrospective Comparative Study', 'orgStudyIdInfo': {'id': 'OBIIA CMNT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1', 'description': 'Patients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries', 'interventionNames': ['Procedure: caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries']}, {'label': 'Group2:', 'description': 'Patients treated by caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries', 'interventionNames': ['Procedure: caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries']}], 'interventions': [{'name': 'caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries', 'type': 'PROCEDURE', 'description': 'Preoperative placement of prophylactic occlusion balloons of both internal iliac arteries (OBIIA) was performed at radiology department. Access to the internal iliac arteries was achieved by retrograde transcutaneous introduction of hydrophilic sheath kits of 8.5 mm under fluoroscopic guidance from both femoral arteries. Once in the lumens of the two internal iliac arteries, the radiologist inflated the balloons until blood flow ceased. The pressure at which occlusion of both internal iliac arteries was achieved was recorded for subsequent replication in the operating room. The radiologist secured the two kits to the skin and applied a compressive dressing. The patient was then directly transferred to the operating room.', 'armGroupLabels': ['Group2:']}, {'name': 'caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries', 'type': 'PROCEDURE', 'description': 'Caesarean hysterectomy was performed through a midline infraumbilical incision. The bladder-uterine peritoneum was dissected, followed by a vertical fundal hysterotomy away from the placenta, and the baby was delivered This was followed by clamping the umbilical cord and closure of the hysterotomy while leaving the placenta in situ without any attempt at traction or delivery and without oxytocin administration.\n\nWe proceeded with the remaining steps of hysterectomy.', 'armGroupLabels': ['Group1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Manouba', 'state': 'Nabeul Governorate', 'country': 'Tunisia', 'facility': 'Haithem Aloui'}, {'zip': '2010', 'city': 'Tunis', 'state': 'Nabeul Governorate', 'country': 'Tunisia', 'facility': 'Haithem Aloui'}], 'overallOfficials': [{'name': 'Haithem Aloui, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tunis University Manar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tunis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'university hospital assistant', 'investigatorFullName': 'Haithem Aloui', 'investigatorAffiliation': 'Tunis University'}}}}