Effects of Systematic Cervical Exam Training on Labor and Delivery Care

Not Applicable

Recruiting

• Conditions: Delivery Problem; Cervix; Pregnancy; Pregnancy Related

• Registration Number: NCT04421768
• Lead Sponsor: Wake Forest University Health Sciences

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-07-23
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-01
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Number of repetitions needed to obtain competence	3 month training period	The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.
Number of exams patients receive	Six month post training	Number of exams per hour of labor or triage visit

Secondary Outcome Measures

Name	Time	Method
Discrepancy between 2 cervical exam assessments--retrospective	Six months period before training and Six months period post training completion	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%
Discrepancy between 2 cervical exam assessments--prospective	Six months period before training and Six months period post training completion	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%

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States