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NCT Number: NCT04421768

Effects of Systematic Cervical Exam Training on Labor and Delivery Care

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

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Key information

Conditions

Delivery Problem Cervix; Pregnancy Dystocia Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Pregnancy Related Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Joshua F Nitsche, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cervical exam training

Behavioral

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 outcomes

  1. Number of repetitions needed to obtain competence

    Time frame: 3 month training period

    The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.

  2. Number of exams patients receive

    Time frame: Six months period before training

    Number of exams per hour of labor or triage visit

  3. Number of exams patients receive

    Time frame: Six month post training

    Number of exams per hour of labor or triage visit

Secondary outcomes

  1. Discrepancy between 2 cervical exam assessments--retrospective

    Time frame: Six months period before training and Six months period post training completion

    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%

  2. Discrepancy between 2 cervical exam assessments--prospective

    Time frame: Six months period before training and Six months period post training completion

    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%

Study contacts

Contact information is provided by the study sponsor or research team.

Devin M Fariss

CONTACT

[email protected]

336.716.4594

Joshua F Nitsche, MD

CONTACT

[email protected]

336.716.6893

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2020
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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