Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT03442218
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2018-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D004716', 'term': 'Endometritis'}], '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'}, {'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2018-02-21', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cases of endometritis after cesarean section', 'timeFrame': '15 days', 'description': 'Endometritis'}], 'secondaryOutcomes': [{'measure': 'Number of cases of cesarean site infection', 'timeFrame': '15 days', 'description': 'Operative site infection'}, {'measure': 'Number of cases of fever (38°C or above) in the puerperium', 'timeFrame': '15 days', 'description': 'Puerperal fever'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean', 'Operative site infection', 'Vaginal wash', 'Clorhexidine', 'Endometritis'], 'conditions': ['Operation Wound; Infection', 'Endometritis']}, 'referencesModule': {'references': [{'pmid': '35051671', 'type': 'DERIVED', 'citation': 'Urena N, Reyes O. Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100572. doi: 10.1016/j.ajogmf.2022.100572. Epub 2022 Jan 17.'}, {'pmid': '32335895', 'type': 'DERIVED', 'citation': 'Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with gestation between 34 and 41 6/7 weeks.\n* Premature rupture of membranes (\\> 6 hours).\n* Use of prophylactic antibiotic 1 hour previous to cesarean section.\n\nExclusion Criteria:\n\n* Any source of infection diagnosed previous to surgery.\n* Fever of unknown origin previous to surgery.'}, 'identificationModule': {'nctId': 'NCT03442218', 'briefTitle': 'Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.', 'orgStudyIdInfo': {'id': 'MHST2014-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clorhexidine', 'description': 'Vaginal wash with clorhexidine solution', 'interventionNames': ['Drug: Clorhexidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline solution', 'description': 'Vaginal wash with saline solution', 'interventionNames': ['Drug: Saline solution']}], 'interventions': [{'name': 'Clorhexidine', 'type': 'DRUG', 'description': 'Vaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes.', 'armGroupLabels': ['Clorhexidine']}, {'name': 'Saline solution', 'type': 'DRUG', 'description': 'Vaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes.', 'armGroupLabels': ['Saline solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'country': 'Panama', 'facility': 'Saint Thomas Maternity Hospital', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sistema Nacional de Investigación (SNI) - Panamá', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head - Research Department', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}