Role of Simulators in Improving Obstetric Vaginal Examination Skills

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05190692
Collaborator
(none)
39
3
4
13
3.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
39 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Prospective Study of the Benefits of Simulators in Improving Obstetric Vaginal Examination Skills
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Outcome Measures

Primary Outcome Measures

  1. learning curve and efficiency of vaginal examination interpretation. Learning curve and efficiency of vaginal examination interpretation. [Five months]

    Simulation training on non experienced house officers will improving or not their vaginal examination skills before performing it on real pregnant women in labor

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kasr Alainy hospital-cairo University Cairo Egypt 11562
2 Obstetrics and gynecology department at kasralainy hospital Cairo Egypt 11562
3 Cairo University Giza Egypt 12613

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shaimaa Mostafa Mohammed Refaay El shemy, Lecturer of Obstetrics and Gynecoloy department, Cairo University
ClinicalTrials.gov Identifier:
NCT05190692
Other Study ID Numbers:
  • Simulators in obstetrics
First Posted:
Jan 13, 2022
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shaimaa Mostafa Mohammed Refaay El shemy, Lecturer of Obstetrics and Gynecoloy department, Cairo University

Study Results

No Results Posted as of Mar 9, 2022