Delivery ProblemNCT04421768
Effects of Systematic Cervical Exam Training on Labor and Delivery Care
A study testing cervical exam training in people with Delivery Problem and Cervix; Pregnancy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Delivery Problem, Cervix; Pregnancy, Pregnancy Related
- What is being tested?
- cervical exam training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,125 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Healthcare providers:
- none
- Patients:
- placenta previa
- vasa previa
- any other contraindication to cervical exam
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Joshua F Nitsche, MD, Joshua.Nitsche@advocatehealth.org
About this study
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
Read the 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.
- Conditions
- Delivery Problem, Cervix; Pregnancy, Pregnancy Related
- Being tested
- cervical exam training
- Keywords
- vaginal delivery, labor cervical exam, labor and delivery
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical exam trainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| systematic cervical exam training--retrospective measures | Experimental | 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 Receives: Behavioral: cervical exam training |
| systematic cervical exam training--prospective measures | Experimental | 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. Receives: Behavioral: cervical exam training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of repetitions needed to obtain competence
The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.
Measured: 3 month training period
Number of exams patients receive
Number of exams per hour of labor or triage visit
Measured: Six months period before training
Number of exams patients receive
Number of exams per hour of labor or triage visit
Measured: Six month post training
Secondary outcomes (2)
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%
Measured: 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%
Measured: Six months period before training and Six months period post training completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start23 Jul 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ProblemStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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
- Masking
- None (open label)
- Enrolment
- 1,125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua F Nitsche, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421768
- Sponsor's protocol ID
- IRB00064273
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2020
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Systematic Cervical Exam Training on Labor and Delivery Care
- ClinicalTrials.gov ID
- NCT04421768
- Acronym / sponsor ID
- IRB00064273
- Conditions
- Delivery Problem, Cervix; Pregnancy, Pregnancy Related
- Keywords
- vaginal delivery, labor cervical exam, labor and delivery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,125 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| systematic cervical exam training--retrospective measures | Experimental | Behavioral: cervical exam trainingEffects 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 |
| systematic cervical exam training--prospective measures | Experimental | Behavioral: cervical exam trainingEffects 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- physicians, midwives, and labor and delivery nurses working on the Labor and Delivery unit within the Wake Forest Baptist Birth Center
- any pregnant women receiving care on the Labor and Delivery unit of Wake Forest Baptist Birth Center
Key exclusion criteria (6 listed)
- none
- placenta previa
- vasa previa
- any other contraindication to cervical exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical exam trainingEach 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 | Behavioural | systematic cervical exam training--prospective measures, systematic cervical exam training--retrospective measures |
Primary outcome
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.
Number of exams patients receive
Time frame: Six months period before training
Number of exams per hour of labor or triage visit
Number of exams patients receive
Time frame: Six month post training
Number of exams per hour of labor or triage visit
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua F Nitsche, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical exam training in people with Delivery Problem and Cervix; Pregnancy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua F Nitsche, MD (336.716.6893, Joshua.Nitsche@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of repetitions needed to obtain competence (time frame: 3 month training period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.