Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT05471102
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2022-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ligation of Anterior Internal Iliac Artery With Conservative Management of Partial or Focal Placenta Accreta Spectrum
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-27', 'studyFirstSubmitDate': '2022-07-03', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of blood loss intra-operative', 'timeFrame': 'during operation', 'description': 'Amount of blood loss intra-operative'}, {'measure': 'Amount of blood loss 24 hours post-operative', 'timeFrame': '24 hours post-operative', 'description': 'Amount of blood loss 24 hours post-operative'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'during operation', 'description': 'duration of the surgery'}, {'measure': 'Number of blood units transfused', 'timeFrame': 'within 24 hours after surgery', 'description': 'Number of blood units transfused within 24 hours after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Accreta']}, 'descriptionModule': {'briefSummary': "The patients will be divided into 2 groups:\n\nGroup (A) - Study group: Cases managed by lower segment resection with ligation of the anterior division of the internal iliac artery\n\nGroup (B) - Control group: Cases managed by lower segment resection without ligation of the anterior division of the internal iliac artery\n\nThe following operative details will be recorded:\n\n* Estimation of total blood loss\n* Pre and 24-h post-operative hemoglobin (g/dl).\n* The need for blood transfusion and its amount intra or postoperative will be recorded\n* Operative time and postoperative hospital stay will be recorded.\n* Close post-operative monitoring of the patients' vital signs, drain output, and urine output\n* Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.\n* Monitoring for postoperative morbidities", 'detailedDescription': "The patients will be divided into 2 groups:\n\nGroup (A) - Study group: Cases managed by uterine lower segment resection with ligation of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery).\n\nGroup (B) - Control group: Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery.\n\nIn both groups, bilateral uterine artery ligation at 2 levels will be done; bilateral ligation at a level below the lower most placental part, followed by bilateral uterine artery ligation at the level of the hysterotomy incision.\n\nThe following operative details will be recorded:\n\n* Estimation of total blood loss\n* Pre and 24-h post-operative hemoglobin (g/dl).\n* The need for blood transfusion and its amount intra or post-operative will be recorded\n* Operative time and postoperative hospital stay will be recorded.\n* Close post-operative monitoring of the patients' vital signs, drain output, and urine output\n* Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.\n* Monitoring for postoperative morbidities"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20-40 years old.\n* Pregnancy of singleton living fetus.\n* Previous one or more cesarean sections.\n* Gestational age: \\> 36 weeks.\n* Elective termination of pregnancy.\n* Cases not requiring preoperative blood transfusion.\n* Cases with focal area of placental adherence or invasion leaving sufficient healthy myometrial tissue for uterine repair and preservation.\n* The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesical hypervascularity".\n\nExclusion Criteria:\n\n* Multifetal pregnancy.\n* More than four previous sections.\n* Emergency termination of pregnancy due to antepartum hemorrhage, placental separation or rupture uterus.\n* Intrauterine fetal death.\n* Women with history of any medical disorder with pregnancy eg. Gestational diabetes and hypertension.\n* Premature rupture of membranes.\n* Cases misdiagnosed as placenta accreta by ultrasound preoperatively, and spontaneous full placental separation occurred intraoperative. "will be excluded before randomization"\n* Cases with PAS with total invasion involving all placental lobules.\n* Cases who will be managed by cesarean hysterectomy due to uncontrolled intraoperative bleeding.'}, 'identificationModule': {'nctId': 'NCT05471102', 'briefTitle': 'Ligation of Anterior Internal Iliac Artery With Conservative Management of Partial or Focal Placenta Accreta Spectrum', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Role of Ligation of the Anterior Division of the Internal Iliac Artery in Conservative Management of Patients Diagnosed With Partial or Focal Placenta Accreta Spectrum', 'orgStudyIdInfo': {'id': 'MS-38-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': 'Cases managed by uterine lower segment resection with ligation ((suturing)) of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery); in addition to the bilateral uterine artery ligation at 2 levels; bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision.', 'interventionNames': ['Procedure: Study group: lower segment resection with ligation of the anterior division of the internal iliac artery']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery. (i.e., only bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision).', 'interventionNames': ['Procedure: Control group: lower segment resection without ligation of the anterior division of the internal iliac artery']}], 'interventions': [{'name': 'Study group: lower segment resection with ligation of the anterior division of the internal iliac artery', 'type': 'PROCEDURE', 'description': 'Cases managed by uterine lower segment resection with ligation ((suturing)) of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery); in addition to the bilateral uterine artery ligation at 2 levels; bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision.', 'armGroupLabels': ['Study group']}, {'name': 'Control group: lower segment resection without ligation of the anterior division of the internal iliac artery', 'type': 'PROCEDURE', 'description': 'Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery. (i.e., only bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision).', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Abdalla Mousa', 'investigatorAffiliation': 'Cairo University'}}}}