Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT05122169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-11-26
First Post:
2021-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011206', 'term': 'Povidone-Iodine'}, {'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participant with episiotomy site infection', 'timeFrame': '21 days', 'description': 'Superficial or deep infection of episiotomy site'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chlorhexidine-alcohol', 'Povidone-iodine', 'Perineal infection', 'Surgical site infection'], 'conditions': ['Vaginal Delivery', 'Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '36810189', 'type': 'DERIVED', 'citation': 'Jung YM, Lee SM, Kim SY, Chung JH, Won HS, Lee KA, Park MH, Cho GJ, Oh MJ, Choi ES, Ahn KH, Hong SC, Sung JH, Roh CR, Kim SM, Kim BJ, Kim HJ, Oh KJ, Hong S, Park IY, Park JS. The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial. Trials. 2023 Feb 21;24(1):130. doi: 10.1186/s13063-023-07101-w.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, controlled trial study to find whether use of chlorhexidine-alcohol or povidone-iodine for pre-vaginal delivery skin prep is superior to reduce postpartum infection in pregnant women with vaginal delivery. The primary outcome is the episiotomy site infection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with singleton pregnancy\n* Women who will undergo vaginal delivery after 37+0/7 weeks of gestation\n\nExclusion Criteria:\n\n* Women who are allergy to chlorhexidine, alcohol, iodine, or shellfish\n* Women with any infection at perineum (before vaginal delivery)'}, 'identificationModule': {'nctId': 'NCT05122169', 'briefTitle': 'Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns', 'orgStudyIdInfo': {'id': 'Vaginal Delivery Skin Prep'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chlorhexidine', 'description': 'Pre-vaginal delivery skip prep using chlorhexidine-alcohol', 'interventionNames': ['Drug: Chlorhexidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Povidone-iodine', 'description': 'Pre-vaginal delivery skip prep using Povidone-iodine', 'interventionNames': ['Drug: Povidone-Iodine']}], 'interventions': [{'name': 'Povidone-Iodine', 'type': 'DRUG', 'otherNames': ['Povidone-iodine 10%'], 'description': 'Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.', 'armGroupLabels': ['Povidone-iodine']}, {'name': 'Chlorhexidine', 'type': 'DRUG', 'otherNames': ['Hexitanol 2% Soln., Chlorhexidine Gluconate Solution'], 'description': 'Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.', 'armGroupLabels': ['chlorhexidine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joong Shin Park', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}