NCT05190692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
Last Updated

August 2, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

December 29, 2021

Last Update Submit

August 1, 2022

Conditions

Keywords

Simulator_vaginal examination_labour

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Two simulators will be used in the study: (1st ) : PROMPT Flex Birthing Simulator Advanced - Light (PRODUCT NO. 80106).UK, 2020 . 2nd): PROMPT Flex Cervical Dilatation \& Effacement Module -Light (PRODUCT NO. 80102),Uk,2020. Both will be used to perform obstetric vaginal examination before examination of patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • House officers with any experience in vaginal examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kasr Alainy hospital-cairo University

Cairo, 11562, Egypt

Location

Obstetrics and gynecology department at kasralainy hospital

Cairo, 11562, Egypt

Location

Cairo University

Giza, 12613, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecoloy department

Study Record Dates

First Submitted

December 29, 2021

First Posted

January 13, 2022

Study Start

March 1, 2022

Primary Completion

July 10, 2022

Study Completion

July 10, 2022

Last Updated

August 2, 2022

Record last verified: 2022-08

Locations