Role of Simulators in Improving Obstetric Vaginal Examination Skills

A Prospective Study of the Benefits of Simulators in Improving Obstetric Vaginal Examination Skills

A prospective study will be performed at the Department of Obstetrics and Gynecology at (VESSALKA unit),at El kasr Al_Ainy hospital, cairo university. Sample of house officers without obstetric experience in vaginal examination that will begin their clinical rotation in the department will be eligible for inclusion in the study. All patients involved in the study must not be high risk pregnancy nor have any indication of cesarean section and they will be examined by house officers in the first stage of labor. House officers and patients will provide verbal informed consent for participation in the study .all house officers assigned in the obstetric and gynecology department for their clinical rotation at the time of study will receive about a (30-mins) standardized course summarizing how to perform an obstetric vaginal examination . All house officers assigned in the study will be trained on vaginal examination simulators in about (15) training sessions and giving them a score to each one about their performing results on simulators.

Study Overview

• Status: Completed
• Conditions: Labour
• Intervention / Treatment: Device: Use simulators in Obstetrics vaginal examination

Detailed Description

This prospective study will be done on a group of house officers without obstetric experience in vaginal examination.

They will perform multiple vaginal examination training procedures using a simulators in about (15) training sessions and giving them a score to each one then testing them on patients who are in the 1st stage of labor and giving them another score after collection of their results .

All house officers will report the findings of examinations of each time in terms of six items (1): cervical dilatation. (2): cervical effacement. (3): presenting part and position. (4): caput or not. (5): station. (6): condition of membrane intact or ruptured.

The findings that will be obtained by the house officers will then be revised by the same staff experienced obstetrician and gynaecologist {whose answers will be considered to be the gold standard} who will examine the same patients at the same time for accuracy of results.

Two simulators will be used in the study:

1. st ) : PROMPT Flex Birthing Simulator Advanced - Light (PRODUCT NO. 80106).UK, 2020 .
2. nd) : PROMPT Flex Cervical Dilatation & Effacement Module -Light (PRODUCT NO. 80102),Uk,2020

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Obstetrics and gynecology department at kasralainy hospital
  • Cairo, Egypt, 11562
    • Kasr Alainy hospital-cairo University
  • Giza, Egypt, 12613
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

- House officers must be without any experience in vaginal examination at the start of study.

Description

Inclusion Criteria:

• House officers must be without any experience in vaginal examination at the start of study.
• Study group must attend at least (15) simulator training sessions before testing them.

Exclusion Criteria:

• House officers with any experience in vaginal examination.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
learning curve and efficiency of vaginal examination interpretation. Learning curve and efficiency of vaginal examination interpretation.	Simulation training on non experienced house officers will improving or not their vaginal examination skills before performing it on real pregnant women in labor	Five months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Simulator_vaginal examination_labour
• Other Study ID Numbers: Simulators in obstetrics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Should vaginal examination simulator be included in the training curriculum for each house officers during their clinical rotation in gynecology and obstetric department?

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No