Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT02374827
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-02-23', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete sterilization procedure', 'timeFrame': 'At time of procedure', 'description': 'The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure'}, {'measure': 'Completion rate of sterilization procedure', 'timeFrame': 'At time of procedure', 'description': 'The primary outcome will involve assessing the completion rate of assigned sterilization procedure'}], 'secondaryOutcomes': [{'measure': 'Total operative time', 'timeFrame': 'At time of procedure', 'description': 'Includes cesarean delivery and sterilization procedure time'}, {'measure': 'Mean post-operative pain score', 'timeFrame': 'Postpartum admission (3-4 days)'}, {'measure': 'Perioperative complication rate', 'timeFrame': 'From time of procedure to 6 weeks postpartum', 'description': 'Composite assessment of the following: estimated blood loss, need for blood transfusion, intra-abdominal hemorrhage/hematoma, need for readmission, need for reoperation, need for additional surgical procedure, major post-operative complication'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['complete salpingectomy', 'standard tubal ligation', 'cesarean delivery', 'feasibility', 'safety', 'partial salpingectomy'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '35728603', 'type': 'DERIVED', 'citation': 'Ostby SA, Blanchard CT, Sanjanwala AR, Szychowski JM, Leath CA 3rd, Huh WK, Subramaniam A. Feasibility, Safety, and Provider Perspectives of Bipolar Electrosurgical Cautery Device for (Opportunistic or Complete) Salpingectomy at the Time of Cesarean Delivery. Am J Perinatol. 2024 Apr;41(6):804-813. doi: 10.1055/s-0042-1748525. Epub 2022 Jun 21.'}, {'pmid': '30477808', 'type': 'DERIVED', 'citation': 'Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath CA 3rd, Biggio JR, Huh WK. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019 Jan;152(1):127-132. doi: 10.1016/j.ygyno.2018.11.009. Epub 2018 Nov 23.'}, {'pmid': '29889762', 'type': 'DERIVED', 'citation': 'Subramaniam A, Blanchard CT, Erickson BK, Szychowski J, Leath CA, Biggio JR, Huh WK. Feasibility of Complete Salpingectomy Compared With Standard Postpartum Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):20-27. doi: 10.1097/AOG.0000000000002646.'}]}, 'descriptionModule': {'briefSummary': 'To compare the feasibility and surgical outcomes between complete salpingectomy and standard postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.', 'detailedDescription': 'All pregnant women receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat) will be approached about the study. Patients will be randomized to receive either the standard tubal ligation practice at our institution (modified Pomeroy procedure or Parkland) or a complete salpingectomy. The objective of this trial is to evaluate if a complete salpingectomy can be performed safely and comparable to a standard postpartum tubal ligation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant women \\> 25 years receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat)\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Inability to obtain informed consent\n* Fetal death or anomalies\n* Preterm delivery \\< 36 weeks gestation\n* Immune-compromising disease\n* Chronic steroid use\n* Chronic prophylactic or therapeutic anti-coagulation\n* Patients no followed in our regional health system\n* Known BRCA mutation carrier status\n* Age \\< 25 years'}, 'identificationModule': {'nctId': 'NCT02374827', 'acronym': 'SCORE', 'briefTitle': 'Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'F140630003 (ST)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard postpartum tubal ligation', 'description': 'In this arm, patients will receive the standard postpartum tubal ligation by accepted methods (procedure names are the following: Modified pomeroy technique or Parkland method). These methods are procedures for completing a partial salpingectomy.', 'interventionNames': ['Procedure: Standard postpartum tubal ligation']}, {'type': 'EXPERIMENTAL', 'label': 'Complete Salpingectomy', 'description': 'In this arm, patients will receive a complete salpingectomy by documented accepted methods.', 'interventionNames': ['Procedure: Complete Salpingectomy']}], 'interventions': [{'name': 'Standard postpartum tubal ligation', 'type': 'PROCEDURE', 'description': 'Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)', 'armGroupLabels': ['Standard postpartum tubal ligation']}, {'name': 'Complete Salpingectomy', 'type': 'PROCEDURE', 'description': 'Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.', 'armGroupLabels': ['Complete Salpingectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Akila Subramaniam, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Britt K Erickson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maternal-Fetal Medicine Fellow', 'investigatorFullName': 'Akila Subramaniam, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}