Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT04766567
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2021-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002585', 'term': 'Cesarean Section'}, {'id': 'D063186', 'term': 'Uterine Myomectomy'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2021-02-21', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications of cesarean myomectomy', 'timeFrame': 'Post-cesarean 12 months', 'description': 'The difference in the rate of complications associated with the cesarean myomectomy (presence of adhesion formation, time to achieve pregnancy (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental abnormalities) in patients undergoing endometrial myomectomy, serosal myomectomy, or not receiving myomectomy during cesarean section'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean section', 'Cesarean myomectomy'], 'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'The present study aims to investigate whether there is a difference in short- and long-term complications in patients undergoing cesarean myomectomy (endometrial or serosal myomectomy) during cesarean section.', 'detailedDescription': 'Myomectomy is frequently performed during cesarean section. Infertility, myoma recurrence, adhesions , uterine rupture (complete/incomplete), impaired uterine healing (partial or complete dehiscence/poor/good), placental abnormalities, and perinatal complications in subsequent pregnancy are may be associated with cesarean myomectomy. In this study, patients who underwent cesarean myomectomy during cesarean section in our institute were analyzed in a retrospective manner. Patients were divided into three groups as those receiving serosal myomectomy, endometrial myomectomy and those who only underwent cesarean section. The groups were compared with respect to the presence of adhesion formation, time to achieve pregnancy (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental abnormalities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants should have singleton pregnancy delivered by cesarean section\n* Cesarean section technique should include: Transverse hysterotomy to enter the uterine cavity, single layer closure of the uterine wall, non-sutured visceral and parietal peritoneum\n* Myomectomy during cesarean section should include: only patients, who have undergone a single myomectomy and have been applied a single layer suture technique with the preservation of the pseudocapsule-for all cesarean myomectomy cases\n\nExclusion Criteria:\n\n* Patients having history of any malignancy\n* Patients with coagulation disorders\n* Patients with a history of previous intraabdominal surgery on reproductive organs\n* Patients with a history of endometriosis'}, 'identificationModule': {'nctId': 'NCT04766567', 'briefTitle': 'Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'Bilge Hospital'}, 'officialTitle': 'Long Term Obstetric, Perinatal and Surgical Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serosal myomectomy', 'description': 'Patients with singleton pregnancy, who had serosal myomectomy during cesarean section', 'interventionNames': ['Procedure: Cesarean section with cesarean myomectomy (serosal)']}, {'type': 'EXPERIMENTAL', 'label': 'Endometrial myomectomy', 'description': 'Patients with singleton pregnancy, who had endometrial myomectomy during cesarean section', 'interventionNames': ['Procedure: Cesarean section with cesarean myomectomy (serosal)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients with singleton pregnancy, who did not have myomectomy during cesarean section', 'interventionNames': ['Procedure: Cesarean section without myomectomy']}], 'interventions': [{'name': 'Cesarean section with cesarean myomectomy (serosal)', 'type': 'PROCEDURE', 'otherNames': ['Cesarean section with cesarean myomectomy (endometrial)'], 'description': 'Serosal or endometrial myomectomy performed during cesarean section', 'armGroupLabels': ['Endometrial myomectomy', 'Serosal myomectomy']}, {'name': 'Cesarean section without myomectomy', 'type': 'PROCEDURE', 'description': 'Cesarean delivery without performing myoemctomy', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Medicana Samsun Hospital', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Oguz Guler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bilge Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bilge Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Oguz Guler', 'investigatorAffiliation': 'Bilge Hospital'}}}}