An interventional study of cervical exam training in Delivery Problem, Cervix; Pregnancy and Pregnancy Related, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive 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
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 1,125 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Healthcare providers:
Patients:
Exclusion Criteria:
Healthcare providers:
Patients:
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Contraindication
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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
Behavioral: cervical exam training
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.
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
Number of repetitions needed to obtain competence
The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.
Time frame: 3 month training period
Number of exams patients receive
Number of exams per hour of labor or triage visit
Time frame: Six months period before training
Number of exams patients receive
Number of exams per hour of labor or triage visit
Time frame: Six month post training
Discrepancy between 2 cervical exam assessments--retrospective
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%
Time frame: Six months period before training and Six months period post training completion
Discrepancy between 2 cervical exam assessments--prospective
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%
Time frame: Six months period before training and Six months period post training completion
Started Jul 2020 (actual). Primary completion is estimated for Dec 2026, 77 months after the start.
Of 18 interventional studies with no phase under Dystocia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 40. This study's planned 77 months is above that.
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