Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-28 @ 6:11 AM
Study NCT ID:
NCT04622267
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2020-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Barbed Suture for Hysterotomy Closure During Cesarean Section
Sponsor:
Organization:
Raw JSON
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control arm', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Barbed Suture', 'description': 'Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 1, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'intrapartum hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quantitative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Suture', 'description': 'Standard antimicrobial suture (vicryl) to close a C-section incision - control arm'}, {'id': 'OG001', 'title': 'Barbed Suture', 'description': 'Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision'}], 'classes': [{'categories': [{'measurements': [{'value': '641.8', 'spread': '300.2', 'groupId': 'OG000'}, {'value': '596.5', 'spread': '283.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, At delivery', 'description': 'Quantification of blood loss (QBL)', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time for Hysterotomy Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Suture', 'description': 'Standard antimicrobial suture (vicryl) to close a C-section incision - control arm'}, {'id': 'OG001', 'title': 'Barbed Suture', 'description': 'Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision'}], 'classes': [{'categories': [{'measurements': [{'value': '326.3', 'spread': '122.1', 'groupId': 'OG000'}, {'value': '277.9', 'spread': '97.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, At delivery', 'description': 'Time for hysterotomy closure', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Need Additional Hemostatic Sutures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Suture', 'description': 'Standard antimicrobial suture (vicryl) to close a C-section incision - 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control arm'}, {'id': 'OG001', 'title': 'Barbed Suture', 'description': 'Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1, At delivery', 'description': 'Number of Participants to assess rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Surgical Site Infections (SSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Suture', 'description': 'Standard antimicrobial suture (vicryl) to close a C-section incision - control arm'}, {'id': 'OG001', 'title': 'Barbed Suture', 'description': 'Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision'}], 'timeFrame': '6 weeks', 'description': 'Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)', 'reportingStatus': 'POSTED', 'populationDescription': 'not collected'}, {'type': 'SECONDARY', 'title': 'Change in Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Suture', 'description': 'Standard antimicrobial suture (vicryl) to close a C-section incision - control arm'}, {'id': 'OG001', 'title': 'Barbed Suture', 'description': 'Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, At delivery and 2 weeks', 'description': 'Change in pain score at 2 weeks from baseline. Pain score from 0 to 10, with higher score indicating more pain.\n\nFollow up pain assessment by a telephone screening 2 weeks following delivery.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Suture', 'description': 'Standard antimicrobial suture (vicryl) to close a C-section incision - control arm'}, {'id': 'FG001', 'title': 'Barbed Suture', 'description': 'Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'recruitment and enrollment conducted from 21 July 2021 through 27 November 2023, and was conducted solely at the Icahn School of Medicine at Mount Sinai Hospital Labor \\& Delivery Unit at 1176 Fifth Avenue, New York, NY 10029.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Suture', 'description': 'Standard antimicrobial suture (vicryl) to close a C-section incision - control arm'}, {'id': 'BG001', 'title': 'Barbed Suture', 'description': 'Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '35.9', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '35.3', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-06', 'size': 346685, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-10T13:47', 'hasProtocol': True}, {'date': '2023-08-15', 'size': 365218, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-10T13:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly assigned to either the treatment arm or control arm of the study prior to commencement of the cesarean section and following informed consent. Allocation will be concealed to all researchers/providers until this point. The patients will be randomly allocated by block randomization. Generation of random sequence will be done by independent personnel, usually a statistician, who is not going to be involved in the conduct of the RCT. The access to this sequence should be restricted to only a few individuals who absolutely need to have access.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2020-11-04', 'resultsFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-14', 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Blood Loss', 'timeFrame': 'Day 1, At delivery', 'description': 'Quantification of blood loss (QBL)'}], 'secondaryOutcomes': [{'measure': 'Time for Hysterotomy Closure', 'timeFrame': 'Day 1, At delivery', 'description': 'Time for hysterotomy closure'}, {'measure': 'Number of Participants Who Need Additional Hemostatic Sutures', 'timeFrame': 'Day 1, At delivery'}, {'measure': 'Number of Hemostatic Sutures', 'timeFrame': 'Day 1, At delivery', 'description': 'Number of hemostatic sutures needed during procedure'}, {'measure': 'Number of Participants With Surgical Site Infections (SSI)', 'timeFrame': 'Day 1, At delivery', 'description': 'Number of Participants to assess rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)'}, {'measure': 'Rate of Surgical Site Infections (SSI)', 'timeFrame': '6 weeks', 'description': 'Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)'}, {'measure': 'Change in Pain Score', 'timeFrame': 'Day 1, At delivery and 2 weeks', 'description': 'Change in pain score at 2 weeks from baseline. Pain score from 0 to 10, with higher score indicating more pain.\n\nFollow up pain assessment by a telephone screening 2 weeks following delivery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Barbed suture', 'Blood loss', 'Hysterotomy', 'Cesarean section'], 'conditions': ['Hysterotomy']}, 'referencesModule': {'references': [{'pmid': '23596641', 'type': 'BACKGROUND', 'citation': 'Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010. 2013 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #149. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/'}, {'pmid': '24920976', 'type': 'BACKGROUND', 'citation': 'Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial. The purpose of this study is to see if patients whose uterine incision (hysterotomy), at the time of scheduled cesarean section, is closed with barbed suture, have less blood loss compared to women whose incision is closed with the standard suture (vicryl). The primary outcome is quantification of blood loss (QBL). Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.\n\nStudy participation will last 1 year and will include the following research procedures :\n\n1. Randomization to barbed suture vs. standard suture\n2. Collection of data for primary and secondary outcomes\n3. Telephone survey 2 weeks following the procedure to assess pain, bowel/bladder habits, and evidence of wound infection. The barbed suture is approved by the FDA for use in soft tissue approximation and this is not an off-label usage.', 'detailedDescription': 'This is a prospective, randomized controlled trial (RCT) evaluating whether using a barbed suture to close a C-section incision can reduce blood loss. Patients undergoing C-section will be randomized with equal allocation to a barbed suture or a standard antimicrobial suture. The primary outcome is quantification of blood loss (QBL). Differences between the groups will be assessed using a 0.05 level Wilcoxon rank-sum test. Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis/SSI (superficial wound infection, deep wound infection, and endometritis) within 6 weeks postpartum, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women are the only subjects eligible for this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing a scheduled primary cesarean section at Mount Sinai Hospital\n* age 18-64.\n\nExclusion Criteria:\n\n* Multifetal gestations\n* Placenta previas\n* Pre-term patients\n* Patients with prior uterine incisions or a coagulopathy (DIC, Von Willebrands Disease, etc)\n* Patients undergoing an unplanned or emergency cesarean section'}, 'identificationModule': {'nctId': 'NCT04622267', 'briefTitle': 'Barbed Suture for Hysterotomy Closure During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Barbed Suture: A Look at Its Use for Hysterotomy Closure During Cesarean Section', 'orgStudyIdInfo': {'id': 'GCO 20-2571'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard suture', 'description': 'Standard antimicrobial suture (vicryl) - control arm', 'interventionNames': ['Procedure: Standard antimicrobial suture']}, {'type': 'EXPERIMENTAL', 'label': 'Barbed suture', 'description': 'Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue', 'interventionNames': ['Device: Barbed suture']}], 'interventions': [{'name': 'Barbed suture', 'type': 'DEVICE', 'otherNames': ['STRATAFIX Symmetric PDS Plus Knotless Tissue'], 'description': 'to close a C-section incision', 'armGroupLabels': ['Barbed suture']}, {'name': 'Standard antimicrobial suture', 'type': 'PROCEDURE', 'otherNames': ['vicryl'], 'description': 'to close a C-section incision', 'armGroupLabels': ['Standard suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Calvin Lambert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor-MSH/MSQ/QHC/SSVS/ELM OBGYN FACULTY - ISM', 'investigatorFullName': 'Calvin Lambert', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}