LabourNCT05190692
Role of Simulators in Improving Obstetric Vaginal Examination Skills
An observational study of Labour, run by Cairo University at 3 sites in Egypt.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Labour
- What is being tested?
- Use simulators in Obstetrics vaginal examination
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Mar 2022to 10 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: - House officers must be without any experience in vaginal examination at the start of study.
Who may be able to join
- 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.
Who cannot join
- House officers with any experience in vaginal examination.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Kasr Alainy hospital-cairo University
Cairo, 11562
Obstetrics and gynecology department at kasralainy hospital
Cairo, 11562
Cairo University
Giza, 12613
About this study
Official title: 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.
Read the 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:
- st ) : PROMPT Flex Birthing Simulator Advanced - Light (PRODUCT NO. 80106).UK, 2020 .
- nd) : PROMPT Flex Cervical Dilatation \& Effacement Module -Light (PRODUCT NO. 80102),Uk,2020
- Conditions
- Labour
- Being tested
- Use simulators in Obstetrics vaginal examination
- Keywords
- Simulator_vaginal examination_labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use simulators in Obstetrics vaginal examinationDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Mar 2022
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LabourStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190692
- Sponsor's protocol ID
- Simulators in obstetrics
- Status last verified
- Aug 2022
- First submitted
- 29 Dec 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Should vaginal examination simulator be included in the training curriculum for each house officers during their clinical rotation in gynecology and obstetric department?
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Benefits of Simulators in Improving Obstetric Vaginal Examination Skills
- ClinicalTrials.gov ID
- NCT05190692
- Acronym / sponsor ID
- Simulators in obstetrics
- Conditions
- Labour
- Keywords
- Simulator_vaginal examination_labour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- st ) : PROMPT Flex Birthing Simulator Advanced - Light (PRODUCT NO. 80106).UK, 2020 .
- nd) : PROMPT Flex Cervical Dilatation \& Effacement Module -Light (PRODUCT NO. 80102),Uk,2020
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - House officers must be without any experience in vaginal examination at the start of study.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- House officers with any experience in vaginal examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use simulators in Obstetrics vaginal examinationTwo 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 | Device | – |
Primary outcome
learning curve and efficiency of vaginal examination interpretation. Learning curve and efficiency of vaginal examination interpretation.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: Undecided. Should vaginal examination simulator be included in the training curriculum for each house officers during their clinical rotation in gynecology and obstetric department?
Related trials for Labour
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
Not yet recruitingObservational study
Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
Intrapartum Fetal Distress
Recruiting
A Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia
Labour Analgesia
Recruiting
Intravenous Papaverine for Term Prelabor Rupture of Membranes
Premature Rupture of Fetal Membranes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labour, run by Cairo University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
learning curve and efficiency of vaginal examination interpretation. Learning curve and efficiency of vaginal examination interpretation. (time frame: Five months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.