Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT06695793
Status:
RECRUITING
Last Update Posted:
2024-11-19
First Post:
2024-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-17', 'studyFirstSubmitDate': '2024-11-17', 'studyFirstSubmitQcDate': '2024-11-17', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of caesarean scar niche and its dimensions.', 'timeFrame': '6-12 weeks post-cesarean section', 'description': "Follow-up visits will be scheduled at 6-12 weeks post-cesarean section to assess caesarean section niche formation using trans-vaginal ultrasound using Samsung Elite with endovaginal probe of frequency 6 - 12 MHz. Trained sonographers, blinded to the participants' suturing group, will perform the ultrasound examinations to evaluate caesarean section niche presence and its dimensions."}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'during operation'}, {'measure': 'Estimate blood loss', 'timeFrame': 'during operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caesarean Scar Niche']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the impact of three different suturing techniques (Running, Interrupted \\& Locked) that used to close the uterine incision at the cesarean section on the formation of a cesarean scar niche'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Women with a singleton pregnancy scheduled for elective cesarean section\n2. Gestational age at the time of cesarean section between 38 and 40 weeks.\n3. Willingness to participate in the study and provide informed consent\n4. Age between 18 and 35 years old.\n5. BMI \\<30\n\nExclusion Criteria:\n\n1. Known uterine anomalies or previous uterine surgery (e.g, myomectomy, uterine septum resection)\n2. Pre-existing medical conditions contraindicating cesarean delivery or affecting uterine healing (e.g., Anemia, Diabetes)\n3. Current smokers.\n4. Non-cephalic presentation of the fetus.\n5. Low-lying anterior wall placenta and placenta previa.\n6. Inability to provide informed consent (e.g., cognitive impairment, language barrier)\n7. Any condition deemed by the attending physician to pose a risk to the participant or compromise the study's integrity, for example, Patients who will require excessive suturing for further hemostasis or those who require ligation of one or both uterine arteries"}, 'identificationModule': {'nctId': 'NCT06695793', 'briefTitle': 'Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)', 'orgStudyIdInfo': {'id': 'MD-308-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (A)', 'description': 'Interrupted Sutures: The first layer of the uterine incision will be closed using individual, separate sutures placed at regular intervals along the incision line. Each suture will be tied independently, ensuring adequate apposition of uterine tissue, followed by a second layer of running continuous sutures.', 'interventionNames': ['Procedure: Interrupted Sutures']}, {'type': 'EXPERIMENTAL', 'label': 'Group (B)', 'description': 'Locked Sutures: The first layer of the uterine incision will be closed using continuous sutures placed along the uterine incision, incorporating a locking technique at specified intervals to prevent unraveling. The knots will be securely tied to maintain tissue approximation, followed by a second layer of running continuous sutures.', 'interventionNames': ['Procedure: Locked Sutures']}, {'type': 'EXPERIMENTAL', 'label': 'Group (C)', 'description': 'Running Continuous Sutures: Double layer closure of uterine incision using running continuous suture used to close the uterine incision without interruption, providing seamless tissue approximation throughout the incision length.', 'interventionNames': ['Biological: Running Continuous Sutures']}], 'interventions': [{'name': 'Interrupted Sutures', 'type': 'PROCEDURE', 'description': 'The first layer of uterine incision will be closed using individual, separate sutures placed at regular intervals along the incision line. Each suture will be tied independently, ensuring adequate apposition of uterine tissue, followed by a second layer of running continuous sutures.', 'armGroupLabels': ['Group (A)']}, {'name': 'Locked Sutures', 'type': 'PROCEDURE', 'description': 'The first layer of uterine incision will be closed using continuous sutures placed along the uterine incision, incorporating a locking technique at specified intervals to prevent unraveling. The knots will be securely tied to maintain tissue approximation, followed by a second layer of running continuous sutures.', 'armGroupLabels': ['Group (B)']}, {'name': 'Running Continuous Sutures', 'type': 'BIOLOGICAL', 'description': 'Double layer closure of uterine incision using running continuous suture used to close the uterine incision without interruption, providing seamless tissue approximation throughout the incision length.', 'armGroupLabels': ['Group (C)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'amr essam', 'role': 'CONTACT', 'email': 'amro_394@hotmail.com', 'phone': '+201004365349'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdalla Mousa', 'role': 'CONTACT', 'email': 'Dr_abdallamousa@yahoo.com', 'phone': '+201277664430'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Moutaz ElSherbiny', 'role': 'CONTACT', 'email': 'mizoelsherbini@yahoo.com', 'phone': '+20100158300'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Soliman', 'role': 'CONTACT', 'email': 'dr_mahmoudsoliman@yahoo.com', 'phone': '+201222251268'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ibrahim Fawzy', 'role': 'CONTACT', 'email': 'ibrahimfawzyibrahimfawzy@gmail.com', 'phone': '+201062641235'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Abdalla Moussa', 'role': 'CONTACT', 'email': 'Dr_abdallamousa@yahoo.com', 'phone': '+20127664430'}, {'name': 'Sally Collins', 'role': 'CONTACT', 'email': 'sally.collins@wrh.ox.ac.uk', 'phone': '+44 7958 656885'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of obgyn Cairo university', 'investigatorFullName': 'Abdalla Mousa', 'investigatorAffiliation': 'Cairo University'}}}}