Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT01285258
Status:
COMPLETED
Last Update Posted:
2011-01-27
First Post:
2011-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emergency Peripartum Hysterectomy: A Prospective Study in Iran
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}, {'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': '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'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007044', 'term': 'Hysterectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-26', 'studyFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death rate', 'timeFrame': 'at 2 minutes after operation'}], 'secondaryOutcomes': [{'measure': 'urological complication', 'timeFrame': 'at 2 minutes after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peripartum', 'hysterectomy', 'placenta accreta', 'mortality'], 'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of peripartum hysterectomy for maternal hemorrhage.', 'detailedDescription': 'Emergency peripartum hysterectomy is a life-saving surgical procedure which performed to control massive hemorrhage. This study was conducted to determine the factors leading to and maternal mortality and morbidity rates among the women whose underwent peripartum hysterectomy with the focus on referral or non-referral patient status.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who have nonresponse hemorrhage after delivery\n\nExclusion Criteria:\n\n* Women who delivered before 24 weeks'}, 'identificationModule': {'nctId': 'NCT01285258', 'briefTitle': 'Emergency Peripartum Hysterectomy: A Prospective Study in Iran', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Study of Peripartum Hysterectomy for Maternal Hemorrhage', 'orgStudyIdInfo': {'id': 'ASD-1213-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'peripartum', 'description': 'patients whom underwent peripartum hysterectomy', 'interventionNames': ['Procedure: hysterectomy']}], 'interventions': [{'name': 'hysterectomy', 'type': 'PROCEDURE', 'description': 'excluding the uterus with saving ovaries', 'armGroupLabels': ['peripartum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Al-zahra university hospital', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'hamidreza shemshaki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD,research comittee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Alireza Yousefy, Associate Professor of Medical Education', 'oldOrganization': 'Isfahan University of Medical Sciences'}}}}