Clinical trial NCT04421768: Effects of Systematic Cervical Exam Training on Labor and Delivery Care
Official title: Effects of Systematic Cervical Exam Training on Labor and Delivery Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delivery Problem
Cervix; Pregnancy
Pregnancy Related
Keywords: vaginal delivery
labor cervical exam
labor and delivery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 1125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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

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

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.

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

Primary outcomes:
measure: Number of repetitions needed to obtain competence
timeFrame: 3 month training period
measure: Number of exams patients receive
timeFrame: Six months period before training
measure: Number of exams patients receive
timeFrame: Six month post training
Secondary outcomes:
measure: Discrepancy between 2 cervical exam assessments--retrospective
timeFrame: Six months period before training and Six months period post training completion
measure: Discrepancy between 2 cervical exam assessments--prospective
timeFrame: Six months period before training and Six months period post training completion
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joshua F Nitsche, MD
role: PRINCIPAL_INVESTIGATOR
References: