Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT04421768
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2020-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Systematic Cervical Exam Training on Labor and Delivery Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004420', 'term': 'Dystocia'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The total number of exams per hour of labor or triage stay and exam discrepancy between 2 examiners will be compared between the 6 month time period before training and 6 months after all nurses have completed the training'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of repetitions needed to obtain competence', 'timeFrame': '3 month training period', 'description': 'The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.'}, {'measure': 'Number of exams patients receive', 'timeFrame': 'Six months period before training', 'description': 'Number of exams per hour of labor or triage visit'}, {'measure': 'Number of exams patients receive', 'timeFrame': 'Six month post training', 'description': 'Number of exams per hour of labor or triage visit'}], 'secondaryOutcomes': [{'measure': 'Discrepancy between 2 cervical exam assessments--retrospective', 'timeFrame': 'Six months period before training and Six months period post training completion', 'description': 'Discrepancy between 2 exam assessments performed less than 30 minutes apart by 2 different examiners:\n\nCervix Dilation will be reported as 1-10 cm Cervix Effacement will be reported as 0% -100%'}, {'measure': 'Discrepancy between 2 cervical exam assessments--prospective', 'timeFrame': 'Six months period before training and Six months period post training completion', 'description': 'Discrepancy between 2 exam assessments performed one after the other by 2 different examiners:\n\nCervix Dilation will be reported as 1-10 cm Cervix Effacement will be reported as 0% -100%'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaginal delivery', 'labor cervical exam', 'labor and delivery'], 'conditions': ['Delivery Problem', 'Cervix; Pregnancy', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'All physicians, nurses, and nurse midwives working on Labor and Delivery will be required to complete cervical exam simulation training. Data before and after institution of the training will be compared to determine if the training leads to less cervical exams during labor and increases consistency between examiners', 'detailedDescription': 'The labor cervical exam is the cornerstone of the management of labor as the accurate assessment of cervical dilation and effacement are crucial in recognizing a normal labor from and abnormal one. To enhance accuracy and precision among healthcare providers working on Labor and Delivery we have created a high fidelity cervical exam simulator. All providers working on Labor and Delivery Repetitive will be required to practice on the simulators until a pre-specified level or accuracy is achieved. We will prospectively and retrospectively assess the number of cervical exams a women receives and the discrepancy between exams performed by 2 different providers both before and after the training is instituted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Physicians, nurses and nurse midwives: any gender Patients: pregnant women only', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthcare providers:\n\n• physicians, midwives, and labor and delivery nurses working on the Labor and Delivery unit within the Wake Forest Baptist Birth Center\n\nPatients:\n\n• any pregnant women receiving care on the Labor and Delivery unit of Wake Forest Baptist Birth Center\n\nExclusion Criteria:\n\nHealthcare providers:\n\n• none\n\nPatients:\n\n* placenta previa\n* vasa previa\n* any other contraindication to cervical exam'}, 'identificationModule': {'nctId': 'NCT04421768', 'briefTitle': 'Effects of Systematic Cervical Exam Training on Labor and Delivery Care', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Effects of Systematic Cervical Exam Training on Labor and Delivery Care', 'orgStudyIdInfo': {'id': 'IRB00064273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'systematic cervical exam training--retrospective measures', 'description': 'Effects of systematic cervical exam training on Labor and Delivery Care The total number of exams per hour of labor or triage stay and exam discrepancy between 2 examiners who performed exams less than 30 minutes apart will be compared between the 6 month time period before the unit wide training and 6 months after completing training', 'interventionNames': ['Behavioral: cervical exam training']}, {'type': 'EXPERIMENTAL', 'label': 'systematic cervical exam training--prospective measures', 'description': 'Effects of systematic cervical exam training on Labor and Delivery care Patient will be approached to obtain consent for them to have 2 cervical exams performed one after the other when an exam is clinically indicated. The discrepancy between the 2 examiners will be compared between the 6 month time period before the unit wide training and 6 months after completion of the training.', 'interventionNames': ['Behavioral: cervical exam training']}], 'interventions': [{'name': 'cervical exam training', 'type': 'BEHAVIORAL', 'description': 'Each nurse will then examine 1 sets of 10 high-fidelity silicone task trainers approximately three per week for a maximum of 20 sessions (200 repetitions total). For each set of 10 exams, the estimates will recorded on an answer sheet. A cumulative summation analysis will be performed on each participant. When an individual nurse achieves competence her training will be suspended', 'armGroupLabels': ['systematic cervical exam training--prospective measures', 'systematic cervical exam training--retrospective measures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua F Nitsche, MD', 'role': 'CONTACT', 'email': 'jnitsche@wakehealth.edu'}], 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Joshua F Nitsche, MD', 'role': 'CONTACT', 'email': 'jnitsche@wakehealth.edu', 'phone': '336.716.6893'}, {'name': 'Devin M Fariss', 'role': 'CONTACT', 'email': 'dfariss@wakehealth.edu', 'phone': '336.716.4594'}], 'overallOfficials': [{'name': 'Joshua F Nitsche, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}