Cervical Exam Training for Childbirth

Overseen By Devin M Fariss

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Placenta previa, vasa previa, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1125 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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

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

Group I: systematic cervical exam training--retrospective measures Experimental Treatment 1 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 measures Experimental Treatment 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Labor Cervical Exam Model in Family Medicine and OB-GYN Residents. Nitsche, JF., Fino, NF., Palomo, JM., et al.[2018]

In a study involving 25 medical students who completed 200 simulated cervical examinations, all students achieved a median accuracy of 69% for dilation and 80% for effacement, indicating effective skill acquisition through practice.

The study found that students required an average of 89 repetitions for dilation and 48 for effacement to reach competence, with skills persisting for 1 month for dilation and 2 months for effacement, suggesting the need for ongoing practice and monitoring of skills post-training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Simulation to Define the Learning Curve for the Digital Cervical Examination. Nitsche, JF., Knupp, RJ., Tooze, JA., et al.[2021]

Medical students who practiced cervical examinations on a larger number of simulation models (10 dilation and 9 effacement/consistency models) showed significantly higher accuracy in assessing cervical dilation and effacement compared to those who practiced on fewer models (4 dilation and 3 effacement/consistency models).

While both training groups improved their confidence, only the larger training group demonstrated significant improvements in accuracy for specific assessments, indicating that while fewer models can enhance basic skills, more extensive practice is necessary for mastering complex evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of different numbers of simulation training models on medical students' cervical examination performance. Lin, W., Song, Y.[2018]

A homemade cervical exam model made from stretchy fabric and pipe cleaners significantly improved the cervical examination skills of interns, demonstrating its effectiveness as a training tool.

Participants reported high satisfaction with the workshop using the model, indicating that this low-cost, easily replicable approach could enhance obstetrical training in residency programs and improve patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning Obstetrical Cervical Exam Skills : Development of a Novel Model to Demystify Blind Procedures. Little, SH., Heinrich, LEA., Sen, A., et al.[2023]

A new low-cost task trainer for cervical cerclage allows medical learners to practice this complex procedure in a safe, nonclinical environment, enhancing their surgical skills.

The trainer is adjustable to simulate various anatomical conditions, making it useful for both beginners and experienced practitioners to maintain proficiency in cervical cerclage placement, which is infrequently performed in modern obstetrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cervical cerclage task trainer for maternal-fetal medicine fellows and obstetrics/gynecology residents. Nitsche, JF., Brost, BC.[2019]

The study introduces a cost-effective and easy-to-build training model for cervical cerclage, addressing the challenges residents and fellows face in gaining hands-on experience with this complex procedure.

This training model aims to enhance the skills of medical trainees, potentially improving patient safety and outcomes in real clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A guide on how to build a novel home-made part task training simulator for cervical cerclage training. Sahbaz, A., Aynioglu, O., Isik, H.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Patterns of Learning in the Labor Cervical Examination. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A Novel Approach to Teaching the Cervical Exam: A Versatile, Low-Cost Simulation for Labor and Delivery Learners. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Labor Cervical Exam Model in Family Medicine and OB-GYN Residents. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Using Simulation to Define the Learning Curve for the Digital Cervical Examination. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of different numbers of simulation training models on medical students' cervical examination performance. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Learning Obstetrical Cervical Exam Skills : Development of a Novel Model to Demystify Blind Procedures. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A cervical cerclage task trainer for maternal-fetal medicine fellows and obstetrics/gynecology residents. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

A guide on how to build a novel home-made part task training simulator for cervical cerclage training. [2017]