Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-25 @ 1:49 PM
Study NCT ID:
NCT04427592
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2020-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Conservative Technique for 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'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2020-05-31', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'new ultrasound sign the pouch', 'timeFrame': 'pre-operative', 'description': 'number of participants that the investigators detected the previously noticed pouch by ultrasound.'}, {'measure': 'significance of the pouch', 'timeFrame': 'peri-operative', 'description': 'the investigators determine the relation of the pouch to estimated blood loss'}, {'measure': 'Pathology', 'timeFrame': 'From the operation time for 48 hours', 'description': 'Histopathological examination of 1 cm specimen from the myometriam attached to the placenta in random cases'}], 'primaryOutcomes': [{'measure': 'surgical outcome', 'timeFrame': 'from the time of the surgery until 48 hours after.', 'description': 'number of participants whom their uterus were preserved without major hemorrhage'}, {'measure': 'intra-operative blood loss', 'timeFrame': 'intraoperative', 'description': 'the amount of blood loss during operation was estimated for each participant.'}, {'measure': 'surgical complications', 'timeFrame': 'intraoperative', 'description': 'number of participants had bladder, ureter injury or hysterectomy,'}, {'measure': 'internal iliac artery ligation', 'timeFrame': 'intra-operative', 'description': 'number of participants had with either unilateral or bilateral internal iliac artery ligation'}, {'measure': 'high dependency unit admission', 'timeFrame': 'from 0 to 48 hours postoperative', 'description': 'number of participants needed high dependency unit admission'}, {'measure': 'wound complications', 'timeFrame': 'up to 2 weeks postoperative', 'description': 'number of patients suffered wound infection'}, {'measure': 'change in the hemoglobin level', 'timeFrame': 'from 48 hours pre operative to 48 hours post operative', 'description': "participant's hemoglobin was measured"}, {'measure': 'blood transfusion', 'timeFrame': 'from 48 hours preoperative to 48 hours postoperative.', 'description': "number of units of blood and it's products transfused to participants"}, {'measure': 'hematuria', 'timeFrame': 'post-operative up to 24 hours', 'description': 'number of participants suffered hematuria'}, {'measure': 'manual cervical assesment', 'timeFrame': 'before skin incision', 'description': 'participants were subjected to vaginal examination to asses the cervix lenght'}, {'measure': 'placental separation', 'timeFrame': 'intra-operative', 'description': 'number of participants whom their placenta was separated manually'}, {'measure': 'surgical grading of the placenta', 'timeFrame': 'intra-operative', 'description': 'number of participants who had accreta, increta, percreta or mixed type'}, {'measure': 'ultrasound grading of the placenta', 'timeFrame': 'pre-operative', 'description': 'number of participants who were diagnosed by ultrasound as accreta, increta or percreta'}, {'measure': 'manual assessment of vaginal fornices', 'timeFrame': 'before skin incision', 'description': 'participants were subjected to vaginal examination to assess fornices'}, {'measure': 'repair time', 'timeFrame': 'intra-operative', 'description': 'the time recorded from the end of the placental separation to the closure of the first layer of the uterus'}, {'measure': 'total operation time', 'timeFrame': 'intra-operative', 'description': 'the time taken from the start of the skin incision to the skin closure'}], 'secondaryOutcomes': [{'measure': 'placental bed', 'timeFrame': 'intra-operative', 'description': 'number of participants that investigators detected a well delineated placental bed like a pouch'}, {'measure': 'pouch site', 'timeFrame': 'intra-operative', 'description': 'the site of the pouch in relation to the cervix'}, {'measure': 'defect site', 'timeFrame': 'intra-operative', 'description': 'the location of the myometrium defects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Accreta Spectrum']}, 'referencesModule': {'references': [{'pmid': '29405320', 'type': 'RESULT', 'citation': 'Sentilhes L, Kayem G, Chandraharan E, Palacios-Jaraquemada J, Jauniaux E; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Conservative management. Int J Gynaecol Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.\n\nInvestigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed.\n\nData were collected about the outcome.', 'detailedDescription': 'Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to help sure diagnosis of PAS.\n\nCesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels.\n\nUterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal Iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age.\n\nExclusion Criteria:\n\n* pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders.\n\npregnant women had 5 or more previous Cesarean sections or their age more than 40 years'}, 'identificationModule': {'nctId': 'NCT04427592', 'acronym': 'percreta', 'briefTitle': 'New Conservative Technique for Placenta Accreta Spectrum', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Placenta Accreta; A Vision for Conservative Surgery', 'orgStudyIdInfo': {'id': 'H.R501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pregnant women with placenta accreta spectrum', 'description': 'The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.', 'interventionNames': ['Diagnostic Test: ultrasound', 'Procedure: closure of uterine wall defect']}], 'interventions': [{'name': 'ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode', 'armGroupLabels': ['pregnant women with placenta accreta spectrum']}, {'name': 'closure of uterine wall defect', 'type': 'PROCEDURE', 'otherNames': ['Double compression suture'], 'description': 'uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.', 'armGroupLabels': ['pregnant women with placenta accreta spectrum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21131', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mahmoud AH Hamdy, A. lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine department of obstetrics and gyneacology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after publication by 1 month', 'ipdSharing': 'YES', 'description': 'all IPD that underlies results in publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mahmoud A Hamdy', 'investigatorAffiliation': 'Alexandria University'}}}}