Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-03 @ 1:50 PM
Study NCT ID:
NCT06531356
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2024-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of wound healing', 'timeFrame': '1,2,6 weeks postoperative', 'description': 'Scars will be assessed objectively regarding Color, Thickness, Pliability, Exudate in participants and controls'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['amniotic fluid', 'cesarean section scar (healing)'], 'conditions': ['High Risk Pregnancy', 'Healing Surgical Wounds']}, 'descriptionModule': {'briefSummary': "The goal of this randomized controlled trial is to investigate the effect of injection of autologous amniotic fluid in the healing of the scar of cesarean section among high-risk population. Investigator's aim is to know : quality of wound healing, rate of infection and time needed for complete healing. Participants will be divided into two groups. All participants will undergo cesarean section. We will inject autologous amniotic fluid in the edges of the wound during skin closure in half of the participants. Wound healing will be assessed at 1st, 2nd and 6th week postoperatively.", 'detailedDescription': 'After surgery, participants will be observed along 6 weeks (at 1, 2 and 6 weeks intervals) and scars will be assessed regarding color, thickness, pliability and presence of exudate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 30 years old.\n* Anemic patients\n* Maternal chronic disease e.g., Diabetes and Hypertension\n* BMI of \\> 25 Kg/m2.\n* Underwent previous CS.\n\nExclusion Criteria:\n\n* Rupture of membrane.\n* No previous section.\n* Anhydraminos.\n* Congenital malformation of the fetus.'}, 'identificationModule': {'nctId': 'NCT06531356', 'briefTitle': 'Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population', 'orgStudyIdInfo': {'id': 'MS-141-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cases', 'interventionNames': ['Biological: autologous amniotic fluid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'interventionNames': ['Other: No amniotic fluid injected in skin edges']}], 'interventions': [{'name': 'autologous amniotic fluid', 'type': 'BIOLOGICAL', 'description': '10 cc of amniotic fluid aspirated after opening uterine incision in cesarean section, then Injected in edges of skin before closure', 'armGroupLabels': ['cases']}, {'name': 'No amniotic fluid injected in skin edges', 'type': 'OTHER', 'description': 'conventional closure of skin', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'state': 'Old Cairo', 'country': 'Egypt', 'facility': 'kasr Al Aini, Faculty of Medicine, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology, Cairo University', 'investigatorFullName': 'Hend Mahmoud Abdelghany', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}