Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:24 AM
Study NCT ID:
NCT07474194
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound infection (surgical site infection SSI)', 'timeFrame': '3 weeks', 'description': 'erythema, tenderness or wound edge separation with purulent discharge involving the cesarean incision site.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection Control / Methods', 'Surgical Site Infection (SSI)']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of preoperative prophylactic administration of clindamycin vaginal cream compared to preoperative vaginal cleansing using a 10% povidone-iodine solution on postpartum infectious morbidity.', 'detailedDescription': "All patients (interventions and control group) are informed not to practice coitus, or use any vaginal products (such as douches, tampons or any type of pessary) during the period of intervention. Also, no vaginal examination was performed to all participants within 3 days of the CS.\n\nThe circulating nurse will clean the skin to all participants by following the manufacturer's guidelines.\n\nThe antiseptic (Povidone-Iodine) is opened, and the surgical site is scrubbed with it. A period of waiting for 3 min was allowed between the application of the antiseptic agent and skin incision to allow the adhesive surgical drapes to stick properly over dry skin.\n\nThe skin of all eligible individuals is aseptically treated in the same technique, using the same materials in an equal amount to control variances.\n\nAll the enrolled participants receive the same health education and wound care advice from the professional health team.\n\nAll participants will be given spinal anesthesia. Patients are catheterized with Foley's catheter no 16 F under complete aseptic conditions then abdominal scrub is performed as usual using povidone iodine. Pfannenstiel incision is performed as usual.\n\nTransverse incision is performed in the lower uterine segment followed by delivery of the baby and the placenta and membrane.\n\nAntibiotics are given according to hospital protocol (ceftriaxone 1gm and metronidazole iv /12 hours in first 24 hours starting within 1 hour from skin incision ) followed by Amoxicillin -clavulanic acid for 5 days after discharge Follow up after cesarean section\n\n* All patients receive routine postoperative care without further interventions.\n* All patients are advised to return to hospital if they develop symptoms of infections such as hotness of the body, foul smelling vaginal discharge, persistent/increasing lower abdominal pain, wound discharge, swelling, redness, or dehiscence"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* female participants with singleton pregnancies scheduled for elective cesarean sections at term, specifically between 37 and 40 weeks of gestation\n* free from any medical disorders.\n* The participants' ages ranged from 18 to 40 years\n* body mass index (BMI) ranged from 18 to 30 kg/m2\n\nExclusion Criteria:\n\n1. Cases of urgent or emergent CS.\n2. Abnormal vaginal secretion (bad smelling yellowish secretion, whitish cheesy discharge with pruritus, bloody discharge; etc…).\n3. Women with medical disorders such as pre-gestational diabetes, anemia, hypertension, preeclampsia, or immunosuppressant pregnant women.\n4. Women who had a skin infection adjacent to the operative site.\n5. Allergy to topical povidone-iodine or clindamycin\n6. Feverish patients or history of premature rupture of membranes or with placenta previa.\n7. patients lost during follow-up were excluded from the final analysis."}, 'identificationModule': {'nctId': 'NCT07474194', 'acronym': 'SSI', 'briefTitle': 'Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Comparative Study of the Effect of Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section', 'orgStudyIdInfo': {'id': 'FMBSUREC/07092025/Salama'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'the control group has only prophylactic antibiotics according to hospital protocols.'}, {'type': 'EXPERIMENTAL', 'label': 'Clindamycin vaginal cream', 'description': 'Clindamycin vaginal cream one applicator each night for 3 nights before CS.', 'interventionNames': ['Drug: Clindamycin vaginal cream']}, {'type': 'EXPERIMENTAL', 'label': 'Vaginal preparation with povidone- iodide solution 10 %', 'description': 'Vaginal preparation with povidone- iodide solution 10 % before skin incision with sponge sticks prior to caesarean section.', 'interventionNames': ['Drug: Vaginal preparation with povidone- iodide solution 10 %']}], 'interventions': [{'name': 'Clindamycin vaginal cream', 'type': 'DRUG', 'description': 'Clindamycin vaginal cream one applicator each night for 3 nights before CS.', 'armGroupLabels': ['Clindamycin vaginal cream']}, {'name': 'Vaginal preparation with povidone- iodide solution 10 %', 'type': 'DRUG', 'description': 'Vaginal preparation with povidone- iodide solution 10 %', 'armGroupLabels': ['Vaginal preparation with povidone- iodide solution 10 %']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sara Abdallah Salem, MD', 'role': 'CONTACT', 'email': 'sara.abdalla@med.bsu.edu.eg', 'phone': '201272842226'}], 'facility': 'Beni suef university', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Sara Abdallah Salem, MD', 'role': 'CONTACT', 'email': 'sara.abdalla@med.bsu.edu.eg', 'phone': '201272842226'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of obstetrics and gynecology', 'investigatorFullName': 'Sara Abdallah Mohamed Salem', 'investigatorAffiliation': 'Beni-Suef University'}}}}