Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-21 @ 1:20 AM
Study NCT ID:
NCT06488092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IC-CS Risk: Patient Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a quality improvement randomized roll-out pre-implementation and post-implementation study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cesarean delivery rate (for any indication)', 'timeFrame': 'at time of delivery'}, {'measure': 'Maternal morbidity', 'timeFrame': 'from delivery to 30 days postpartum', 'description': 'one or more of the following: endometritis, postpartum hemorrhage greater than or equal to one liter, wound infection requiring antibiotics, venous thromboembolism, hysterectomy, intensive care unit admission, readmission within 30 days, and death'}], 'secondaryOutcomes': [{'measure': 'Neonatal morbidity', 'timeFrame': 'delivery admission', 'description': 'one or more of the following: severe respiratory distress, neonatal resuscitation outside of delivery room, and sepsis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Delivery']}, 'descriptionModule': {'briefSummary': 'This study is looking at the impact of the implementation of a cesarean risk calculator on cesarean delivery and maternal morbidity rates.', 'detailedDescription': 'In this study a cesarean risk calculator will be instituted as a part of standard of care in a randomized rollout at 14 labor and delivery clinical sites across 4 institutions. The leadership at all of the sites have planned to implement this intervention for routine use at both sites. This study will evaluate cesarean delivery rates and maternal morbidity before and after implementation at each site.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll postpartum patients who were eligible for cesarean risk calculator utilization:\n\n* delivery of a full-term (greater than or equal to 37 weeks) singleton gestation after presenting\n* with intact membranes\n* undergoing an induction of labor from cervical dilation less than or equal to 2cm\n\nExclusion Criteria:\n\nPostpartum patient who had a prior pregnancy resulting in Cesarean delivery'}, 'identificationModule': {'nctId': 'NCT06488092', 'briefTitle': 'IC-CS Risk: Patient Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Implementation of Calculated Cesarean Section Risk Study: Patient-focused Outcomes', 'orgStudyIdInfo': {'id': '854955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Pre-utilization of cesarean risk calculator', 'description': 'The time prior to the implementation of the cesarean risk calculator at the labor and delivery unit.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Implementation of cesarean risk calculator', 'description': 'The cesarean risk calculator will be incorporated into routine care at the site', 'interventionNames': ['Other: Cesarean Risk Calculator']}], 'interventions': [{'name': 'Cesarean Risk Calculator', 'type': 'OTHER', 'description': 'The cesarean risk calculator will be incorporated into routine care at the site', 'armGroupLabels': ['Implementation of cesarean risk calculator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Macomb Hospital', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'E.W. Sparrow Hospital', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '08536', 'city': 'Plainsboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Princeton Medical Center', 'geoPoint': {'lat': 40.33344, 'lon': -74.60043}}, {'zip': '44307', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Akron General', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '44111', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Fairview Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hillcrest Hospital', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '17602', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster General Health', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19380', 'city': 'West Chester', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Chester County Hosptial', 'geoPoint': {'lat': 39.96097, 'lon': -75.60804}}, {'zip': '84341', 'city': 'Logan', 'state': 'Utah', 'country': 'United States', 'facility': 'Logan Regional Hospital-Intermountain Healthcare', 'geoPoint': {'lat': 41.73549, 'lon': -111.83439}}, {'zip': '84403', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'McKay-Dee Hospital', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '84065', 'city': 'Riverton', 'state': 'Utah', 'country': 'United States', 'facility': 'Riverton Hospital-Intermountain Healthcare', 'geoPoint': {'lat': 40.52189, 'lon': -111.9391}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Rebecca Hamm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rebecca Feldman Hamm', 'investigatorAffiliation': 'University of Pennsylvania'}}}}