Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-28 @ 9:48 AM
Study NCT ID:
NCT07053995
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFECTIVENESS OF PREOPERATIVE VAGINAL CLEANING IN REDUCING POST CAESAREAN INFECTIOUS MORBIDITY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endometrial Infection', 'timeFrame': '14 days', 'description': 'Body temperature was measured postoperatively along with any dicharge of pain around uterine region 24hrs after surgery'}, {'measure': 'Surgical site infection', 'timeFrame': '14 days', 'description': 'Incision site was inspected on 4th and 14th post operative day and documented any evidence of infection signs according to Southampton wound grading system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial', 'Infection', 'Surgical Site Infection Following Cesarean Delivery']}, 'descriptionModule': {'briefSummary': 'After obtaining an informed consent a detailed history and clinical examination was performed. Labs were carried out to fulfill inclusion and exclusion criteria. Women were randomly divided into two groups. In Intervention group vaginal cleaning was done with 50cc diluted antiseptic solution where as control group had abdominal scrub only. Participants were followed and incision site was checked at day 14.', 'detailedDescription': 'After obtaining an informed consent a detailed history and clinical examination was performed. Labs were carried out to fulfill inclusion and exclusion criteria. Women were randomly divided into two groups. In Intervention group vaginal cleaning was done with 50cc diluted antiseptic solution as single push where as control group had abdominal scrub only. Participants were followed and incision site was checked at day 14. Data was recorded and analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 18-40 years\n* Gestational age greater than 36 weeks undergoing elective C section\n\nExclusion Criteria:\n\n* Pregnant women with history of allergic reactions to chlorhexidine\n* Placenta previa on ultrasound scan\n* Diabetes Mellitus on fasting blood sugar\n* Anemia (Hb less than 7g/dl)'}, 'identificationModule': {'nctId': 'NCT07053995', 'briefTitle': 'EFFECTIVENESS OF PREOPERATIVE VAGINAL CLEANING IN REDUCING POST CAESAREAN INFECTIOUS MORBIDITY', 'organization': {'class': 'OTHER', 'fullName': 'Khyber Teaching Hospital'}, 'officialTitle': 'EFFECTIVENESS OF PREOPERATIVE VAGINAL CLEANING IN REDUCING POST CAESAREAN INFECTIOUS MORBIDITY', 'orgStudyIdInfo': {'id': '978'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with vaginal cleaning', 'description': 'Total of 38 participants included randomly after informed consent. Vaginal cleaning with 50cc (0.5cc chlorhexidine) along with abdominal scrubbing was done before giving incision for C-section. Prophylactic antibiotics were given. Participants were followed and incision site was inspected on day 14. Data was recorded.', 'interventionNames': ['Procedure: Vaginal cleaning']}, {'type': 'OTHER', 'label': 'Participants with non vaginal cleansing', 'description': 'Total of 38 participants included randomly after informed consent. Only routine abdominal scrubbing was done before giving incision for C-section. Prophylactic antibiotics were given. Participants were followed and incision site was inspected on day 14. Data was recorded.', 'interventionNames': ['Other: Non vaginal cleansing']}], 'interventions': [{'name': 'Vaginal cleaning', 'type': 'PROCEDURE', 'description': 'Before giving incision for C-section surgery, vaginal cleaning was done with 50cc diluted antiseptic solution as a single push.', 'armGroupLabels': ['Participants with vaginal cleaning']}, {'name': 'Non vaginal cleansing', 'type': 'OTHER', 'description': 'Routine abdominal scrubbing was carried out before incision. No vaginal cleaning was done before incision.', 'armGroupLabels': ['Participants with non vaginal cleansing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23301', 'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Khyber Teaching Hospital Peshawar Pakistan', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Dr Hira Hassan, MBBS FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Khyber Teaching Hospital Peshawar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khyber Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Naba Rehman', 'investigatorAffiliation': 'Khyber Teaching Hospital'}}}}