Obstetric TraumaPERFORMACNCT04670380
Optimizing the Obstetrician's Movement During a Simulated Forceps Operative Vaginal Delivery (PERFORMAC)
An observational study of Obstetric Trauma, run by Poitiers University Hospital.
Trial summary
Operative vaginal delivery is the main risk factor for pelvic floor trauma occurrence and especially for obstetric anal sphincter injuries. These complications are strongly and negatively impact women's health: fecal incontinence, perineal pain, sexual dysfunction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obstetric Trauma
- What is being tested?
- Posture and movement analysis during a simulated forceps vaginal operative delivery
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 2 Jun 2021
- 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: The population will be constituted of 40 volunteers that are medical doctor obstetricians or registrar in obstetrics with an experience of the operative vaginal delivery using Suzor's Forceps. All the participants will be aged of 18 or more and will give their informed and written free consent before any investigation. There is no patient in this study which is a simulation study performed on MD and registrar.
Who may be able to join
- Medical doctor or registrar that have an experience of operative vaginal delivery using forceps in their clinical activity
Who cannot join
- No practice of the forceps at all
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optimizing the Obstetrician's Movement During a Simulated Forceps Operative Vaginal Delivery. A Biomechanical Study Using Optometric Captation (PERFORMAC)
Operative vaginal delivery is the main risk factor for pelvic floor trauma occurrence and especially for obstetric anal sphincter injuries. These complications are strongly and negatively impact women's health: fecal incontinence, perineal pain, sexual dysfunction.
The risk appears higher in case of operative vaginal delivery assisted by forceps compared to a vacuum delivery. This considered it is likely that optimizing the performance of the operator that perform the operative vaginal delivery will reduce the morbidity associated with this intervention. There are data bout how to optimize the placement of the forceps on the fetal head before performing the delivery but there are no data about the movement of the obstetrician during this intervention.
Read more
The objective is to analyse the posture and the movement of the obstetrician during a simulated forceps operative vaginal delivery using a 3D cinematic analysis. Secondary objectives are to analyse the traction force applied on the forceps during the delivery, to describe the different postures in terms of stability and last to compare the self-declared practice to the objectively observed.
This is a prospective study including 40 volunteers (medical doctors and registrars).
Each volunteer will perform a simulated operative vaginal delivery using a Suzor's Forceps on a high fidelity mannequin. Postures and movement will be assessed using optometric analysis. The force of traction will be assessed during the operative delivery thank to a force sensor on the forceps. The self declared practice collected thanks to individual questionnaires will be compared to the observed practice during the simulation.
The prospects are to identify the best posture and movement for performing an operative vaginal delivery and to promote tools for simulation of medical students.
- Conditions
- Obstetric Trauma
- Being tested
- Posture and movement analysis during a simulated forceps vaginal operative delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posture and movement analysis during a simulated forceps vaginal operative deliveryOther
It will be request from each volunteer to perform a vaginal operative delivery using a Suzor's forceps on a mannequin. The condition will be standardized (anterior occiput low fetal presentation). Each participant will be equipped with 34 reflecting markers allowing to record their movement using infra red cameras (VICON system).
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the postures and the movement during the simulated operative vaginal delivery
measures of angles on joints for the different phases of the operative vaginal delivery
Measured: Day of inclusion
Secondary outcomes (3)
Analysis of the traction force during the operative delivery
Continuous measure of the traction force during the delivery (in Newton) thanks to a force sensor implemented in the forceps
Measured: Day of inclusion
Analysis of the postures in terms of stability
Measure of the gravity center projection, the support basis
Measured: Day of inclusion
Compare self-declared practice to the observed practice
Comparison of the postures self-declared in a questionnaire immediately before the simulation to those observed during the simulation
Measured: Day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion2 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric TraumaStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670380
- Sponsor's protocol ID
- PERFORMAC
- Acronym
- PERFORMAC
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Obstetrician's Movement During a Simulated Forceps Operative Vaginal Delivery. A Biomechanical Study Using Optometric Captation (PERFORMAC)
- ClinicalTrials.gov ID
- NCT04670380
- Acronym / sponsor ID
- PERFORMAC / PERFORMAC
- Conditions
- Obstetric Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 2 Jun 2021 (estimated)
- First posted
- 17 Dec 2020 (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.
Operative vaginal delivery is the main risk factor for pelvic floor trauma occurrence and especially for obstetric anal sphincter injuries. These complications are strongly and negatively impact women's health: fecal incontinence, perineal pain, sexual dysfunction.
The risk appears higher in case of operative vaginal delivery assisted by forceps compared to a vacuum delivery. This considered it is likely that optimizing the performance of the operator that perform the operative vaginal delivery will reduce the morbidity associated with this intervention. There are data bout how to optimize the placement of the forceps on the fetal head before performing the delivery but there are no data about the movement of the obstetrician during this intervention.
The objective is to analyse the posture and the movement of the obstetrician during a simulated forceps operative vaginal delivery using a 3D cinematic analysis. Secondary objectives are to analyse the traction force applied on the forceps during the delivery, to describe the different postures in terms of stability and last to compare the self-declared practice to the objectively observed.
This is a prospective study including 40 volunteers (medical doctors and registrars).
Each volunteer will perform a simulated operative vaginal delivery using a Suzor's Forceps on a high fidelity mannequin. Postures and movement will be assessed using optometric analysis. The force of traction will be assessed during the operative delivery thank to a force sensor on the forceps. The self declared practice collected thanks to individual questionnaires will be compared to the observed practice during the simulation.
The prospects are to identify the best posture and movement for performing an operative vaginal delivery and to promote tools for simulation of medical students.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population will be constituted of 40 volunteers that are medical doctor obstetricians or registrar in obstetrics with an experience of the operative vaginal delivery using Suzor's Forceps. All the participants will be aged of 18 or more and will give their informed and written free consent before any investigation. There is no patient in this study which is a simulation study performed on MD and registrar.
Key inclusion criteria (1 listed)
- Medical doctor or registrar that have an experience of operative vaginal delivery using forceps in their clinical activity
Key exclusion criteria (1 listed)
- No practice of the forceps at all
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 |
|---|---|---|
| Posture and movement analysis during a simulated forceps vaginal operative deliveryIt will be request from each volunteer to perform a vaginal operative delivery using a Suzor's forceps on a mannequin. The condition will be standardized (anterior occiput low fetal presentation). Each participant will be equipped with 34 reflecting markers allowing to record their movement using infra red cameras (VICON system). | Other | – |
Primary outcome
Analysis of the postures and the movement during the simulated operative vaginal delivery
Time frame: Day of inclusion
measures of angles on joints for the different phases of the operative vaginal delivery
3 secondary outcomes
Analysis of the traction force during the operative delivery
Time frame: Day of inclusion
Analysis of the postures in terms of stability
Time frame: Day of inclusion
Compare self-declared practice to the observed practice
Time frame: Day of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Trauma, run by Poitiers University Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand GACHON, MD; PhD Student (+33549443945, bertrand.gachon@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the postures and the movement during the simulated operative vaginal delivery (time frame: Day of inclusion). 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 17 Dec 2020.