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Effects of Systematic Cervical Exam Training on Labor and Delivery Care

Effects of Systematic Cervical Exam Training on Labor and Delivery Care

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04421768
Enrollment
1125
Registered
2020-06-09
Start date
2020-07-23
Completion date
2026-12-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix; Pregnancy, Delivery Problem, Pregnancy Related

Keywords

vaginal delivery, labor cervical exam, labor and delivery

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.

Interventions

BEHAVIORALcervical 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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of repetitions needed to obtain competence3 month training periodThe number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.
Number of exams patients receiveSix months period before trainingNumber of exams per hour of labor or triage visit

Secondary

MeasureTime frameDescription
Discrepancy between 2 cervical exam assessments--retrospectiveSix months period before training and Six months period post training completionDiscrepancy 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--prospectiveSix months period before training and Six months period post training completionDiscrepancy 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%

Countries

United States

Contacts

CONTACTJoshua F Nitsche, MD
Joshua.Nitsche@advocatehealth.org336.716.6893
CONTACTDevin M Fariss
Devin.Fariss@Advocatehealth.org336.716.4594
PRINCIPAL_INVESTIGATORJoshua F Nitsche, MD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026