Effects of Systematic Cervical Exam Training on Labor and Delivery Care

Pregnancy Related Clinical Trial

Official title:

Effects of Systematic Cervical Exam Training on Labor and Delivery Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04421768
• Other study ID #: IRB00064273
• Status: Recruiting
• Phase: N/A
• Start date: July 23, 2020
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Wake Forest University Health Sciences
• Contact: Joshua F Nitsche, MD
• Phone: 336.716.6893
• Email: jnitsche[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1125
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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 Exclusion Criteria:

Healthcare providers:

• none

Patients:

• placenta previa
• vasa previa
• any other contraindication to cervical exam

Related Conditions & MeSH terms

• Cervix; Pregnancy
• Delivery Problem
• Dystocia
• Pregnancy Related

Intervention

Behavioral:
• cervical exam training
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

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of exams patients receive	Number of exams per hour of labor or triage visit	Six months period before training
Primary	Number of exams patients receive	Number of exams per hour of labor or triage visit	Six month post training
Secondary	Discrepancy between 2 cervical exam assessments--retrospective	Discrepancy between 2 exam assessments performed less than 30 minutes apart by 2 different examiners: Cervix Dilation will be reported as 1-10 cm Cervix Effacement will be reported as 0% -100%	Six months period before training and Six months period post training completion
Secondary	Discrepancy between 2 cervical exam assessments--prospective	Discrepancy between 2 exam assessments performed one after the other by 2 different examiners: Cervix Dilation will be reported as 1-10 cm Cervix Effacement will be reported as 0% -100%	Six months period before training and Six months period post training completion