Effects of Systematic Cervical Exam Training on Labor and Delivery Care

January 29, 2024 updated by: Wake Forest University Health Sciences
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: systematic cervical exam training--retrospective measures
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
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
Experimental: systematic cervical exam training--prospective measures
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of repetitions needed to obtain competence
Time Frame: 3 month training period
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
Time Frame: Six months period before training
Number of exams per hour of labor or triage visit
Six months period before training
Number of exams patients receive
Time Frame: Six month post training
Number of exams per hour of labor or triage visit
Six month post training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrepancy between 2 cervical exam assessments--retrospective
Time Frame: 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%
Six months period before training and Six months period post training completion
Discrepancy between 2 cervical exam assessments--prospective
Time Frame: 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%
Six months period before training and Six months period post training completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Joshua F Nitsche, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2020

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00064273

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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