Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT03830502
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2019-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2019-02-03', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motivators for sterilization type', 'timeFrame': 'Evaluation at preoperative 32th gestational weeks', 'description': 'A non-validated data collection tool with open-ended questions assessing the factors behind the decision of salpingectomy or tubal ligation. Data collection tool questions why patients choosed or refused salpingectomy in detail. It is not a scale and does not have a range.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prophylactic salpingectomy', 'Opportunistic salpingectomy', 'Risk-reducing'], 'conditions': ['Salpingectomy', 'Sterilization, Tubal']}, 'referencesModule': {'references': [{'pmid': '30591122', 'type': 'BACKGROUND', 'citation': 'Zamorano AS, Mutch DG. Postpartum salpingectomy: a procedure whose time has come. Am J Obstet Gynecol. 2019 Jan;220(1):8-9. doi: 10.1016/j.ajog.2018.09.041. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Prophylactic (Opportunistic) salpingectomy is a cost-effective strategy recommended for reducing the risk of ovarian cancer at the time of gynecologic surgery in women who have completed childbearing. Similar evidence for cesarean section is growing. However, salpingectomy refers to the surgical removal of a female reproductive organ. Some women may have hesitations about salpingectomy with regard to religious concerns, reduced self-image, tubal reanastomosis or lack of knowledge.\n\nThe investigators aimed to explore the underlying factors that motivate women for either decisions.', 'detailedDescription': 'Prophylactic and opportunistic bilateral salpingectomy is an increasing trend among surgeons and also proven as an effective risk-reducing method for ovarian cancer.\n\nThe investigators have experienced denials among women who were seeking tubal ligation as a sterilization procedure during cesarean section after a comprehensive counseling for prophylactic salpingectomy. Therefore, the investigators aimed to assess the driving factors of decision making for prophylactic salpingectomy or tubal ligation. It is planned to preoperatively have a non-validated questionnaire for the women after a detailed briefing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who aged over 18 years old and seek for sterilization at the time of cesarean section.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women seeking for surgical sterilization during their cesarean section\n* Elective and Category 2 or more planned cesarean sections\n\nExclusion Criteria:\n\n* Clinical conditions that lead to planned cesarean hysterectomy such as placenta percreata\n* History of ovarian cancer, previous chemotherapy or radiation\n* Women who previously underwent sterilization'}, 'identificationModule': {'nctId': 'NCT03830502', 'briefTitle': 'Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bartin State Hospital'}, 'officialTitle': 'Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section', 'orgStudyIdInfo': {'id': 'EtfalSalp'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Salpingectomy', 'description': 'Women who gave consent for opportunistic prophylactic bilateral salpingectomy during cesarean section as a Surgical sterilization procedure', 'interventionNames': ['Procedure: Surgical sterilization']}, {'label': 'Tubal ligation', 'description': 'Women who refused salpingectomy and gave consent for tubal ligation during cesarean section as a Surgical sterilization procedure', 'interventionNames': ['Procedure: Surgical sterilization']}], 'interventions': [{'name': 'Surgical sterilization', 'type': 'PROCEDURE', 'description': 'Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique', 'armGroupLabels': ['Salpingectomy', 'Tubal ligation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bartın', 'country': 'Turkey (Türkiye)', 'facility': 'Bartin State Hospital', 'geoPoint': {'lat': 41.63583, 'lon': 32.3375}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Medicalpark Gaziosmanpasa Hospital, Istinye University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Murat Yassa, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Specialist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bartin State Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Murat Yassa', 'investigatorAffiliation': 'Bartin State Hospital'}}}}