Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-02-01 @ 6:26 PM
Study NCT ID:
NCT03707132
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2018-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010921', 'term': 'Placenta Accreta'}, {'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], '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'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2018-10-07', 'studyFirstSubmitQcDate': '2018-10-12', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated blood loss', 'timeFrame': 'peroperatively', 'description': 'Blood spoliation during procedure'}, {'measure': 'Hemoglobin variation', 'timeFrame': 'First 24 hours', 'description': 'the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure'}, {'measure': 'Transfusion requirements', 'timeFrame': 'First 24 hours', 'description': 'Number of red blood cells units transfused'}, {'measure': 'procedure duration', 'timeFrame': 'peroperatively', 'description': 'Time needed to perform hysterectomy from incision to skin closure'}, {'measure': 'Intensive care transfer rate', 'timeFrame': 'first 24 hours', 'description': 'Intensive care transfer following hysterectomy for placenta accreta'}], 'secondaryOutcomes': [{'measure': 'length of stay in ICU', 'timeFrame': 'time from surgery up to 30 days postoperative', 'description': 'duration of the stay in the ICU following hysterectomy for placenta accreta'}, {'measure': 'clotting disorders', 'timeFrame': 'time from surgery up to 30 days postoperative', 'description': 'Assessed by the incidence of Intravascular disseminated coagulopathy'}, {'measure': 'Bladder wound', 'timeFrame': 'time from surgery up to 30 days postoperative', 'description': 'Incidence of accidental bladder damage'}, {'measure': 'Digestive wound', 'timeFrame': 'time from surgery up to 30 days postoperative', 'description': 'Incidence of accidental digestive lesion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tourniquet', 'low uterus segment', 'placenta accreta', 'hysterectomy', 'massive blood loss management'], 'conditions': ['Placenta Accreta', 'Post Partum Hemorrhage', 'Blood Loss Massive']}, 'descriptionModule': {'briefSummary': 'Monocentric prospective observational study comparing the use of tourniquet in low uterus segement versus standard procedure in hysterectomy owing to placenta accreta', 'detailedDescription': 'It is a monocentric prospective observational case-control study in the Department "C" of Gynecology and Obstetrics in the Maternity and Neonatology Center of Tunis during three years from October 2014 to September 2017.\n\nAll parturient were informed about the possibility of performing a hysterectomy if accretization was clinically confirmed preoperatively. After obtaining written formal consent. all patients who underwent scheduled or emergency cesarean section for placenta accreta were included. Either it was highly suspected or confirmed by obstetrical imaging. MRI was always performed in cases of scheduled cesarean delivery. However, in cases of delayed transfer or if parturient was already in labor, only ultrasonography was done and considered as sufficient. Delivery was usually scheduled at 36 weeks of gestation.\n\nPatients were allocated into two group: Group TG in which a tourniquet was systematically applied on the lower segment of the uterus during emergent hysterectomy, control group CG when the emergent caesarian hysterectomy was performed without a tourniquet. Allocation depended on the technique and the decision of the surgeon in charge.\n\nAfter appropriate conditioning and monitoring, the cesarean section was performed under general anesthesia. The laparotomy was performed through a mid-line incision from the umbilicus to the pubic symphysis. Hysterotomy was made far from the placental insertion which was previously located by ultrasonography. The accretization was clinically checked immediately after delivery but no attempt was made to manually remove the placenta. The umbilical cord was ligated to its insertion and the uterus was quickly sutured with the placenta kept in place. Careful detachment of the bladder-uterus peritoneum was then carried out in order to lower the bladder and reduce the risk of bladder wounds. Tourniquet application procedure is described as following\n\n1. Suturing hysterotomy with placenta kept in place.\n2. After a cautious dissection a Folley catheter is placed in the lower segment of the uterus as tourniquet.\n3. complete hysterectomy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All parturients with suspected placenta accreta either on MRI if the C section is scheduled or on Ultrasound if an emmergent delivery is set', 'genderDescription': 'female pregnant subject', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* . All patients undergoing scheduled or emergency cesarean section for placenta accreta\n\nExclusion Criteria:\n\n* No signs of accretetization upon artificial delivery'}, 'identificationModule': {'nctId': 'NCT03707132', 'briefTitle': 'Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold', 'orgStudyIdInfo': {'id': 'Garrot-Accreta'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tourniquet Group', 'description': "'Tourniquet: Folley catheter in the low segment of the uterus", 'interventionNames': ['Procedure: Tourniquet: Folley catheter in the low segment of the uterus']}, {'label': 'Control Group', 'description': 'Standard hysterectomy is performed'}], 'interventions': [{'name': 'Tourniquet: Folley catheter in the low segment of the uterus', 'type': 'PROCEDURE', 'armGroupLabels': ['Tourniquet Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hayen Maghrebi, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tunis Maternity Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical associate professor', 'investigatorFullName': 'Ben marzouk Sofiene', 'investigatorAffiliation': 'University Tunis El Manar'}}}}