search
Back to results

Effects of Systematic Cervical Exam Training on Labor and Delivery Care

Primary Purpose

Delivery Problem, Cervix; Pregnancy, Pregnancy Related

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cervical exam training
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Delivery Problem focused on measuring vaginal delivery, labor cervical exam, labor and delivery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

systematic cervical exam training--retrospective measures

systematic cervical exam training--prospective measures

Arm 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

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.

Outcomes

Primary Outcome Measures

Number of repetitions needed to obtain competence
The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.
Number of exams patients receive
Number of exams per hour of labor or triage visit
Number of exams patients receive
Number of exams per hour of labor or triage visit

Secondary Outcome Measures

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%
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%

Full Information

First Posted
June 4, 2020
Last Updated
June 14, 2023
Sponsor
Wake Forest University Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04421768
Brief Title
Effects of Systematic Cervical Exam Training on Labor and Delivery Care
Official Title
Effects of Systematic Cervical Exam Training on Labor and Delivery Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery Problem, Cervix; Pregnancy, Pregnancy Related
Keywords
vaginal delivery, labor cervical exam, labor and delivery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
systematic cervical exam training--retrospective measures
Arm Type
Experimental
Arm 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
Arm Title
systematic cervical exam training--prospective measures
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
cervical exam training
Intervention 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
Primary Outcome Measure Information:
Title
Number of repetitions needed to obtain competence
Description
The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.
Time Frame
3 month training period
Title
Number of exams patients receive
Description
Number of exams per hour of labor or triage visit
Time Frame
Six months period before training
Title
Number of exams patients receive
Description
Number of exams per hour of labor or triage visit
Time Frame
Six month post training
Secondary Outcome Measure Information:
Title
Discrepancy between 2 cervical exam assessments--retrospective
Description
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%
Time Frame
Six months period before training and Six months period post training completion
Title
Discrepancy between 2 cervical exam assessments--prospective
Description
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%
Time Frame
Six months period before training and Six months period post training completion

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Physicians, nurses and nurse midwives: any gender Patients: pregnant women only
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua F Nitsche, MD
Phone
336.716.6893
Email
jnitsche@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Devin M Fariss
Phone
336.716.4594
Email
dfariss@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua F Nitsche, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua F Nitsche, MD
Email
jnitsche@wakehealth.edu

12. IPD Sharing Statement

Learn more about this trial

Effects of Systematic Cervical Exam Training on Labor and Delivery Care

We'll reach out to this number within 24 hrs