Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05190692 |
| Other study ID # |
Simulators in obstetrics |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
July 10, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
