Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 6:55 AM
Study NCT ID:
NCT04048356
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D059952', 'term': 'Pelvic Floor Disorders'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pjeppson@salud.unm.edu', 'phone': '505-967-8428', 'title': 'Peter Jeppson, site contact for study', 'organization': 'University of New Mexico'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Chlorhexidine Gluconate', 'description': 'Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Povidone Iodine', 'description': 'Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Surgical Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SSI'}, {'term': 'Bronchitis', 'notes': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Bronchitis'}, {'term': 'Suture reaction', 'notes': 'suture abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Suture reaction'}, {'term': 'Skin irritation', 'notes': 'self-limited delayed vulvar skin irritation 72 hours after surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Vuvlar irritation'}, {'term': 'Bacterial Vaginosis', 'notes': 'BV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'BV'}, {'term': 'Urethral injury', 'notes': 'urethral injury at the time of aborted midurethral sling placement.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Urethral injury'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Urinary Tract Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Gluconate', 'description': 'Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}, {'id': 'OG001', 'title': 'Povidone Iodine', 'description': 'Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks post operatively', 'description': 'Urinary tract infection as defined by positive urine culture of \\>10,000 cfu, or empirically treated symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Gluconate', 'description': 'Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}, {'id': 'OG001', 'title': 'Povidone Iodine', 'description': 'Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days postoperatively', 'description': 'Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vaginal Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Gluconate', 'description': 'Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}, {'id': 'OG001', 'title': 'Povidone Iodine', 'description': 'Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}], 'classes': [{'categories': [{'title': 'Vaginal irritation - 0', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'title': 'Vaginal irritation - 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Vaginal irritation - 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Vaginal irritation - 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Vaginal irritation - 4 or 5', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post operative day 1', 'description': 'Vaginal irritation (including specific symptoms of discomfort, burning, or itching) based on a 5-point scale (Likert type, from 0 minimum/better to 5 maximum/worse, total score reported))', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chlorhexidine Gluconate', 'description': 'Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}, {'id': 'FG001', 'title': 'Povidone Iodine', 'description': 'Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chlorhexidine Gluconate', 'description': 'Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}, {'id': 'BG001', 'title': 'Povidone Iodine', 'description': 'Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.\n\nVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '13', 'groupId': 'BG000'}, {'value': '57', 'spread': '12', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Latinx', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'American Indian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-22', 'size': 284895, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-20T11:59', 'hasProtocol': True}, {'date': '2020-10-22', 'size': 154719, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-20T12:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be anesthetized during the intervention and will not be informed of the arm of their randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2019-08-02', 'resultsFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-20', 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Urinary Tract Infection', 'timeFrame': '2 weeks post operatively', 'description': 'Urinary tract infection as defined by positive urine culture of \\>10,000 cfu, or empirically treated symptoms.'}], 'secondaryOutcomes': [{'measure': 'Rate of Surgical Site Infection', 'timeFrame': '14 days postoperatively', 'description': 'Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf'}, {'measure': 'Vaginal Irritation', 'timeFrame': 'Post operative day 1', 'description': 'Vaginal irritation (including specific symptoms of discomfort, burning, or itching) based on a 5-point scale (Likert type, from 0 minimum/better to 5 maximum/worse, total score reported))'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urogynecology', 'Surgery', 'Antiseptic Preparation'], 'conditions': ['Pelvic Organ Prolapse', 'Urinary Incontinence', 'Pelvic Floor Disorders', 'Gynecologic Disease', 'Post-Op Infection', 'Surgical Site Infection', 'Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '34973179', 'type': 'DERIVED', 'citation': 'Rockefeller NF, Petersen TR, Komesu YM, Meriwether K, Dunivan G, Ninivaggio C, Jeppson PC. Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. Am J Obstet Gynecol. 2022 Jul;227(1):66.e1-66.e9. doi: 10.1016/j.ajog.2021.12.260. Epub 2021 Dec 29.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.', 'detailedDescription': 'The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female Subjects \\>18 years of age\n* English or Spanish speaking/reading\n* Must be able to provide informed consent\n* Undergoing urogynecologic procedures or surgery\n\nExclusion Criteria:\n\n* Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient.\n* Inability to return for follow-up visits\n* No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation\n* Lack of telephone\n* Known allergy to either antiseptic agent\n* Prisoners will not be eligible to participate in this study'}, 'identificationModule': {'nctId': 'NCT04048356', 'acronym': 'CLNUP', 'briefTitle': 'Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures', 'orgStudyIdInfo': {'id': '19-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine gluconate', 'description': 'Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.', 'interventionNames': ['Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Povidone Iodine', 'description': 'Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.', 'interventionNames': ['Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.']}], 'interventions': [{'name': 'Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.', 'type': 'DRUG', 'description': 'Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.', 'armGroupLabels': ['Chlorhexidine gluconate', 'Povidone Iodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Karen Taylor, BA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of New Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}