Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-26 @ 5:48 AM
Study NCT ID:
NCT03602950
Status:
UNKNOWN
Last Update Posted:
2018-07-27
First Post:
2018-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRP Use in Diabetic Patients Undergoing Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The intervention group will receive PRP at surgery, whereas the control group will receive the usual care. All patients will be evaluated at baseline, one week, four weeks and eight week after the cesarean section.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2018-07-06', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in wound healing', 'timeFrame': 'one week post-operatively', 'description': 'REEDA descriptive scale will assess degree of wound healing which formed of 4 points in a categorical score assessing 5 items of healing, redness, edema,ecchymosis,discharge ,approximation of the wound edges. each item is rated on a scale of 0-3 and total score may range between 0-15. lower scores indicating good healing'}], 'secondaryOutcomes': [{'measure': 'morbidly wound healing', 'timeFrame': '4-8weeks', 'description': 'at 4 and 8 weeks post-operatively the wound healing will be completed and will be assessed using VSS,Vancouver scar scale, which detect formation of keloid or hypertrophic scars. it will assess vascularity, scar thickness, pliability and pigmentation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes, Gestational', 'Wound Complication']}, 'descriptionModule': {'briefSummary': 'this study will investigate the effectiveness of PRP in wound healing among diabetic patients undergoing elective cesarean sections', 'detailedDescription': 'In this balanced, randomized, and controlled prospective study, 100 pregnant ladies at full term diabetic patients will be admitted to Minia University hospital. The patients will be randomly assigned into two groups. The intervention group will receive PRP at surgery, whereas the control group will receive the usual care. All patients will be evaluated at baseline, one week, two weeks, four weeks and eight week after the cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria will be a fixed factor along with age(18 y:45 y),diabetic patients(any type of diabetes),elective delivery,average body mass index(BMI) (17 : 24.9),Non previously scared uterus ,single pregnancy\n\nExclusion Criteria:\n\n* The exclusion criteria will be younger ages below 18 years ,older ages above 45 years, emergency caesarean delivery, previous scared uterus, underweight BMI below 17, overweight BMI above 24.9, no other medical problems, associated other diseases, and multiple pregnancy'}, 'identificationModule': {'nctId': 'NCT03602950', 'briefTitle': 'PRP Use in Diabetic Patients Undergoing Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Role of Autologous Platelet-Rich Plasma Solution in Wound Healing in Diabetic Patients Undergoing Elective Cesarean Delivery', 'orgStudyIdInfo': {'id': 'MiniaU2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '50 diabetic ladies at full term will undergo elective CS and will receive the usual surgical care routinely done at our hospital'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'study group', 'description': '50 diabetic ladies will undergo elective CS at full term and autologous PRP will be injected subcutaneously before skin closure.', 'interventionNames': ['Biological: PRP']}], 'interventions': [{'name': 'PRP', 'type': 'BIOLOGICAL', 'description': 'autologous PRP will be injected subcutaneously before skin closure at time of elective CS', 'armGroupLabels': ['study group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Hany Hassan Kamel', 'investigatorAffiliation': 'Minia University'}}}}