<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421768</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00064273</org_study_id>
    <nct_id>NCT04421768</nct_id>
  </id_info>
  <brief_title>Effects of Systematic Cervical Exam Training on Labor and Delivery Care</brief_title>
  <official_title>Effects of Systematic Cervical Exam Training on Labor and Delivery Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      All physicians, nurses, and nurse midwives working on Labor and Delivery will be required to&#xD;
      complete cervical exam simulation training. Data before and after institution of the training&#xD;
      will be compared to determine if the training leads to less cervical exams during labor and&#xD;
      increases consistency between examiners&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The labor cervical exam is the cornerstone of the management of labor as the accurate&#xD;
      assessment of cervical dilation and effacement are crucial in recognizing a normal labor from&#xD;
      and abnormal one. To enhance accuracy and precision among healthcare providers working on&#xD;
      Labor and Delivery we have created a high fidelity cervical exam simulator. All providers&#xD;
      working on Labor and Delivery Repetitive will be required to practice on the simulators until&#xD;
      a pre-specified level or accuracy is achieved. We will prospectively and retrospectively&#xD;
      assess the number of cervical exams a women receives and the discrepancy between exams&#xD;
      performed by 2 different providers both before and after the training is instituted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_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</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of repetitions needed to obtain competence</measure>
    <time_frame>3 month training period</time_frame>
    <description>The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of exams patients receive</measure>
    <time_frame>Six months period before training</time_frame>
    <description>Number of exams per hour of labor or triage visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of exams patients receive</measure>
    <time_frame>Six month post training</time_frame>
    <description>Number of exams per hour of labor or triage visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Discrepancy between 2 cervical exam assessments--retrospective</measure>
    <time_frame>Six months period before training and Six months period post training completion</time_frame>
    <description>Discrepancy between 2 exam assessments performed less than 30 minutes apart by 2 different examiners:&#xD;
Cervix Dilation will be reported as 1-10 cm Cervix Effacement will be reported as 0% -100%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discrepancy between 2 cervical exam assessments--prospective</measure>
    <time_frame>Six months period before training and Six months period post training completion</time_frame>
    <description>Discrepancy between 2 exam assessments performed one after the other by 2 different examiners:&#xD;
Cervix Dilation will be reported as 1-10 cm Cervix Effacement will be reported as 0% -100%</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1125</enrollment>
  <condition>Delivery Problem</condition>
  <condition>Cervix; Pregnancy</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>systematic cervical exam training--retrospective measures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>systematic cervical exam training--prospective measures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cervical exam training</intervention_name>
    <description>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</description>
    <arm_group_label>systematic cervical exam training--prospective measures</arm_group_label>
    <arm_group_label>systematic cervical exam training--retrospective measures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthcare providers:&#xD;
&#xD;
        • physicians, midwives, and labor and delivery nurses working on the Labor and Delivery&#xD;
        unit within the Wake Forest Baptist Birth Center&#xD;
&#xD;
        Patients:&#xD;
&#xD;
        • any pregnant women receiving care on the Labor and Delivery unit of Wake Forest Baptist&#xD;
        Birth Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Healthcare providers:&#xD;
&#xD;
        • none&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  placenta previa&#xD;
&#xD;
          -  vasa previa&#xD;
&#xD;
          -  any other contraindication to cervical exam&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Physicians, nurses and nurse midwives: any gender Patients: pregnant women only</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua F Nitsche, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joshua F Nitsche, MD</last_name>
    <phone>336.716.6893</phone>
    <email>jnitsche@wakehealth.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Devin M Fariss</last_name>
    <phone>336.716.4594</phone>
    <email>dfariss@wakehealth.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua F Nitsche, MD</last_name>
      <email>jnitsche@wakehealth.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaginal delivery</keyword>
  <keyword>labor cervical exam</keyword>
  <keyword>labor and delivery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dystocia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421768
org study id: IRB00064273
nct id: NCT04421768
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention 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
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of repetitions needed to obtain competence
time frame: 3 month training period
description: The number of simulated cervical exams each provider needs to reach a pre-specified level of accuracy.
measure: Number of exams patients receive
time frame: Six months period before training
description: Number of exams per hour of labor or triage visit
measure: Number of exams patients receive
time frame: Six month post training
description: Number of exams per hour of labor or triage visit
measure: Discrepancy between 2 cervical exam assessments--retrospective
time frame: Six months period before training and Six months period post training completion
description: 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%
measure: Discrepancy between 2 cervical exam assessments--prospective
time frame: Six months period before training and Six months period post training completion
description: 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%
arm group label: systematic cervical exam training--retrospective measures
arm group type: Experimental
description: 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
arm group label: systematic cervical exam training--prospective measures
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: cervical exam training
description: 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
arm group label: systematic cervical exam training--prospective measures
arm group label: systematic cervical exam training--retrospective measures
criteria: 
gender: All
gender based: Yes
gender description: Physicians, nurses and nurse midwives: any gender Patients: pregnant women only
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joshua F Nitsche, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Joshua F Nitsche, MD
phone: 336.716.6893
email: jnitsche@wakehealth.edu
last name: Devin M Fariss
phone: 336.716.4594
email: dfariss@wakehealth.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Dystocia