Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04421768

Conditions

Delivery Problem

Cervix; Pregnancy

Pregnancy Related

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

cervical exam training

Study Details

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

Conditions

Delivery Problem

Cervix; Pregnancy

Pregnancy Related

Study ID

NCT04421768

Start date

Jul 23, 2020

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1125 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: systematic cervical exam training--retrospective measures

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

experimental: systematic cervical exam training--prospective measures

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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Joshua F Nitsche, MD

336.716.6893Joshua.Nitsche@advocatehealth.org

Devin M Fariss

336.716.4594Devin.Fariss@Advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Joshua F Nitsche, MD

Joshua.Nitsche@advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • vaginal delivery
  • labor cervical exam
  • labor and delivery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-17.