1125 Participants Needed

Cervical Exam Training for Childbirth

JF
DM
Overseen ByDevin M Fariss
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment Cervical Exam Training for Childbirth?

Research shows that using simulation models for cervical exam training helps improve the accuracy and skills of medical students and residents in performing cervical exams, which are important for assessing labor progress during childbirth.12345

How does Cervical Exam Training differ from other treatments for childbirth?

Cervical Exam Training is unique because it uses low-cost, homemade simulation models to teach healthcare professionals how to perform cervical exams during childbirth. This approach is different from traditional on-the-job training, which can be uncomfortable for patients and may increase infection risk. The simulation models provide a safe and effective way to learn and practice these skills without needing real patients.23678

What is the purpose of this trial?

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

Research Team

JF

Joshua F Nitsche, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for physicians, midwives, and labor & delivery nurses at Wake Forest Baptist Birth Center. It also includes pregnant women receiving care there. The goal is to see if special training on cervical exams can improve childbirth outcomes.

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

Patients: any other contraindication to cervical exam
Patients: placenta previa
Patients: vasa previa

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

All providers practice on cervical exam simulators until a pre-specified level of accuracy is achieved

3 months

Prospective Assessment

Prospective assessment of cervical exams performed by two different providers to measure discrepancy

6 months

Retrospective Assessment

Retrospective assessment of cervical exams to compare the number of exams and discrepancies before and after training

6 months

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

Treatment Details

Interventions

  • Cervical Exam Training
Trial Overview The study tests whether cervical exam simulation training for healthcare providers can reduce the number of cervical exams during labor and make the results more consistent among different examiners.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: systematic cervical exam training--retrospective measuresExperimental Treatment1 Intervention
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
Group II: systematic cervical exam training--prospective measuresExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Findings from Research

Medical students showed significant improvement in accurately assessing cervical dilation and effacement over time, with accuracy rates increasing from 52% to 84% for dilation and from 35% to 93% for effacement as they progressed in their training.
Initially, students tended to overestimate both dilation and effacement, but as they gained experience, their estimations became more balanced, indicating a need for targeted training to address these common errors in early practice.
Evaluation of the Patterns of Learning in the Labor Cervical Examination.Nitsche, JF., Goodridge, E., Kim, SM., et al.[2020]
The report details the creation of low-cost cervical exam models designed to teach essential obstetrical skills such as cervical dilation and effacement, as well as artificial rupture of membranes (AROM) and fetal scalp electrode (FSE) placement.
These models are intended for use in educational settings for nurses, medical students, and residents, aiming to enhance their ability to assess labor progress effectively.
A Novel Approach to Teaching the Cervical Exam: A Versatile, Low-Cost Simulation for Labor and Delivery Learners.Perry, JD., Maples, JM., Deisher, HN., et al.[2022]
Training with a PVC pipe-based cervical exam model significantly improved the accuracy of first-year family medicine and OB-GYN residents in assessing cervical dilation after an 8-day simulation course.
Interns who used the simulation model were more accurate and had less variability in their assessments compared to more experienced OB-GYN residents who received traditional training, highlighting the effectiveness of simulation in medical education.
Effectiveness of a Labor Cervical Exam Model in Family Medicine and OB-GYN Residents.Nitsche, JF., Fino, NF., Palomo, JM., et al.[2018]

References

Evaluation of the Patterns of Learning in the Labor Cervical Examination. [2020]
A Novel Approach to Teaching the Cervical Exam: A Versatile, Low-Cost Simulation for Labor and Delivery Learners. [2022]
Effectiveness of a Labor Cervical Exam Model in Family Medicine and OB-GYN Residents. [2018]
Using Simulation to Define the Learning Curve for the Digital Cervical Examination. [2021]
Effectiveness of different numbers of simulation training models on medical students' cervical examination performance. [2018]
Learning Obstetrical Cervical Exam Skills : Development of a Novel Model to Demystify Blind Procedures. [2023]
A cervical cerclage task trainer for maternal-fetal medicine fellows and obstetrics/gynecology residents. [2019]
A guide on how to build a novel home-made part task training simulator for cervical cerclage training. [2017]
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