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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether special training for healthcare providers can enhance the quality of cervical exams during labor. The goal is to determine if this training can reduce the number of exams and ensure consistency among different examiners. Healthcare providers at a specific birth center and pregnant women receiving care there participate in the trial. Women with conditions such as placenta previa (when the placenta covers the cervix) are not eligible. As an unphased trial, this study allows participants to contribute to improving healthcare practices and outcomes for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that this cervical exam training is safe?

Research has shown that training healthcare professionals to perform cervical exams is generally safe. While specific safety data for the training itself isn't provided, similar programs are common in medical education and are usually well-tolerated.

Cervical exams are a routine part of managing labor, involving the assessment of cervical dilation during childbirth. The training ensures that doctors and nurses perform these exams consistently, leading to better care during childbirth.

The trial is in a "Not Applicable" phase, focusing on training methods rather than testing new medical treatments. No evidence suggests harm from participating in this training. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve accuracy in cervical exams during childbirth through systematic training. Unlike standard practices where discrepancies between examiners might occur, this approach focuses on reducing those differences by comparing exams conducted before and after the training. By refining exam consistency, the trial could enhance patient care during labor and delivery, leading to more reliable assessments and potentially better outcomes for both mothers and babies.

What evidence suggests that cervical exam training is effective for improving labor and delivery care?

Research has shown that training for cervical exams can greatly improve the accuracy and consistency of these exams. In one study, 65-100% of students became skilled in their exam techniques after practicing with simulations. Another study found that medical students became more accurate in performing cervical exams with this training. This trial will evaluate the effects of systematic cervical exam training on labor and delivery care. One arm of the trial will use prospective measures to assess the impact of training, while another arm will use retrospective measures. Standardized training has been linked to better adherence to recommended exam schedules, which can help lower the number of cesarean sections. Overall, these findings suggest that cervical exam training improves the quality and consistency of exams, potentially leading to better outcomes during labor and delivery. ^{1 6 7 8 9}

Who Is on the Research Team?

Joshua F Nitsche, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26375554/

Effectiveness of Labor Cervical Examination Simulation in ... In the cumulative summation analyses, 65-100% of students attained competence during the clerkship depending on the level of accuracy and cervical parameter ...

2. journals.lww.com journals.lww.com/greenjournal/fulltext/2015/10001/Effectiveness_of_Labor_Cervical_Examination.4.aspx?generateEpub=Article%7Cgreenjournal:2015:10001:00004%7C10.1097/aog.0000000000001027%7C

Effectiveness of Labor Cervical Examination Simulation in ... To estimate whether simulation training improves medical students' cervical examination accuracy. The training paradigm for the labor cervical examination ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8511352/

Identifying the effective components of a standardized ... Within a standardized labor induction protocol, adherence to cervical exams every 1–2 h in active labor was associated with reduced cesarean rate, and adherence ...

4. journals.stfm.org journals.stfm.org/familymedicine/2023/january/little-2022-0112/

Learning Obstetrical Cervical Exam Skills : Development of ... Results: Interns demonstrated a significant improvement in cervical exam skills using the model, and participants reported very high satisfaction with the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1871519224003032

The effectiveness of antenatal education on improving ... Antenatal education programs studied improve some labour and birth outcomes, although with substantial heterogeneity regarding mode of birth and epidural ...

6. ajog.org ajog.org/article/S0002-9378(25)00473-9/fulltext

Clinical outcomes following implementation of an operative ... Objective. To compare clinical outcomes from operative vaginal birth before and after the implementation of a safety bundle at Monash Health, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6984379/

The Effects of Childbirth Education on Maternity Outcomes ... This study explored the relationship between attendance of set curriculum childbirth education class and the labor and birth process, as well as maternal ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933321000239

Novel device vs manual examinations for the measurement ... This randomized controlled trial compares a novel device with the standard method of manual examination for the measurement of cervical dilation.

9. acog.org acog.org/clinical/clinical-guidance/clinical-practice-guideline/articles/2024/01/first-and-second-stage-labor-management

First and Second Stage Labor Management This guideline provides definitions for labor arrest, along with recommendations for management of dystocia in the first and second stages of labor.