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Recruiting NCT04421768

Effects of Systematic Cervical Exam Training on Labor and Delivery Care

No phase Interventional Delivery Problem Cervix; Pregnancy Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cervical exam training.
Who it may be relevant to
Registry conditions: Delivery Problem, Cervix; Pregnancy, Pregnancy Related. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Behavioral cervical 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

Primary outcome measures

  • Number of repetitions needed to obtain competence [Time frame: 3 month training period]
  • Number of exams patients receive [Time frame: Six months period before training]
  • Number of exams patients receive [Time frame: Six month post training]
Secondary outcome measures (2)
  • Discrepancy between 2 cervical exam assessments--retrospective [Time frame: Six months period before training and Six months period post training completion]
  • Discrepancy between 2 cervical exam assessments--prospective [Time frame: Six months period before training and Six months period post training completion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT04421768 · IRB00064273

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗