Effects of Systematic Cervical Exam Training on Labor and Delivery Care
1 other identifier
interventional
1,125
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
July 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
December 18, 2025
June 1, 2025
5.9 years
June 4, 2020
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of repetitions needed to obtain competence
The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.
3 month training period
Number of exams patients receive
Number of exams per hour of labor or triage visit
Six months period before training
Number of exams patients receive
Number of exams per hour of labor or triage visit
Six month post training
Secondary Outcomes (2)
Discrepancy between 2 cervical exam assessments--retrospective
Six months period before training and Six months period post training completion
Discrepancy between 2 cervical exam assessments--prospective
Six months period before training and Six months period post training completion
Study Arms (2)
systematic cervical exam training--retrospective measures
EXPERIMENTALEffects 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
systematic cervical exam training--prospective measures
EXPERIMENTALEffects 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Healthcare providers:
- physicians, midwives, and labor and delivery nurses working on the Labor and Delivery unit within the Wake Forest Baptist Birth Center
- Patients:
- any pregnant women receiving care on the Labor and Delivery unit of Wake Forest Baptist Birth Center
You may not qualify if:
- Healthcare providers:
- none
- Patients:
- placenta previa
- vasa previa
- any other contraindication to cervical exam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua F Nitsche, MD
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2020
First Posted
June 9, 2020
Study Start
July 23, 2020
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
December 18, 2025
Record last verified: 2025-06