Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT04799457
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2021-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013536', 'term': 'Suture Techniques'}], 'ancestors': [{'id': 'D058106', 'term': 'Wound Closure Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'One study control person is organizing the whole trial and provides blinding to both sides (participants and care provider).'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double Blinded Randomised Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants for each group for study', 'timeFrame': 'Up to 9 months', 'description': 'We will try to reach fifty participants for each group (study group as classical cesarean with supporting suture and control group as classical cesarean) . When we reach to all participants we will stop to enroll the participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['niche', 'caesarean section', 'technique', 'uterine closure'], 'conditions': ['Uterine Niche', 'Closure; Incomplete, Uterus']}, 'referencesModule': {'references': [{'pmid': '26489989', 'type': 'RESULT', 'citation': 'Bennich G, Rudnicki M, Wilken-Jensen C, Lousen T, Lassen PD, Wojdemann K. Impact of adding a second layer to a single unlocked closure of a Cesarean uterine incision: randomized controlled trial. Ultrasound Obstet Gynecol. 2016 Apr;47(4):417-22. doi: 10.1002/uog.15792.'}, {'pmid': '26522861', 'type': 'RESULT', 'citation': 'Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11.'}, {'pmid': '24680843', 'type': 'RESULT', 'citation': 'Sevket O, Ates S, Molla T, Ozkal F, Uysal O, Dansuk R. Hydrosonographic assessment of the effects of 2 different suturing techniques on healing of the uterine scar after cesarean delivery. Int J Gynaecol Obstet. 2014 Jun;125(3):219-22. doi: 10.1016/j.ijgo.2013.11.013. Epub 2014 Feb 28.'}, {'pmid': '29215795', 'type': 'RESULT', 'citation': 'Stegwee SI, Jordans I, van der Voet LF, van de Ven PM, Ket J, Lambalk CB, de Groot C, Hehenkamp W, Huirne J. Uterine caesarean closure techniques affect ultrasound findings and maternal outcomes: a systematic review and meta-analysis. BJOG. 2018 Aug;125(9):1097-1108. doi: 10.1111/1471-0528.15048. Epub 2018 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'Caesarean section scar may have result as isthmocele or scar detachment during pregnancy which is in few years after previous delivery. Uterine niche is the most effectively used measurement side of uterus to estimate for these detachment complications. The aim of this study is to support this niche site by supporting the classical uterine closure technique.', 'detailedDescription': 'Cesarean delivery rate continues to increase in world in concern with uterine scar complications as placental invasion abnormalities, isthmocele or previous scar detachment during pregnancy (post surgical long term complications). Uterine niche is the presence of a hypoechoic area within the myometrium on the lower uterine segment, showing a defect of the myometrium at the site of a previous cesarean delivery. Some surgical techniques have been trying to support this area to prevent the post surgical long term complications. In this study the investigators have been trying to find out a new technique by applying supporting sutures during uterine closure in cesarean section. Three months after the surgery, the uterine niche measurement will be examined with ultrasonography for both study and classical groups and results will be compared between the groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This trial will be conducted at an obstetrics and gynecology clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primigravid elective caesarian delivery candidates\n* The participants will have not any uterine contraction or cervical dilatation before delivery.\n* Having no systemic or obstetric illnesses\n* Participants who are accept to participate in this study with their written consent.\n\nExclusion Criteria:\n\n* Previous caesarian delivery\n* Having uterine contraction or cervical dilatation\n* Smoking cigarettes\n* Having systemic or obstetric illnesses'}, 'identificationModule': {'nctId': 'NCT04799457', 'briefTitle': 'Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.', 'orgStudyIdInfo': {'id': '2021/0077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Classical caesarean group', 'description': 'Care providers are applying standard caesarean procedure for participants.'}, {'type': 'EXPERIMENTAL', 'label': 'Study caesarean group', 'description': 'Care providers are applying additional sutures to standard caesarean procedure for participants.', 'interventionNames': ['Other: Suture technique']}], 'interventions': [{'name': 'Suture technique', 'type': 'OTHER', 'description': 'We wil apply additional sutures to classical caesarean procedure.', 'armGroupLabels': ['Study caesarean group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34722', 'city': 'Istanbul', 'state': 'Kadikoy', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ergul Demircivi Bor', 'role': 'CONTACT', 'email': 'drergul@yahoo.com', 'phone': '+902166065200'}, {'name': 'Ergul Demircivi Bor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mehmet Kucukbas', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Prof Dr Suleyman Yalcin Goztepe City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ergul Demircivi Bor', 'role': 'CONTACT', 'email': 'drergul@yahoo.com', 'phone': '+902166065200', 'phoneExt': '360206'}], 'overallOfficials': [{'name': 'Ergul Demircivi Bor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof Dr Suleyman Yalcin Goztepe City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ergul Demircivi Bor', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}