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Optimizing the Obstetrician's Movement During a Simulated Forceps Operative Vaginal Delivery (PERFORMAC)

Optimizing the Obstetrician's Movement During a Simulated Forceps Operative Vaginal Delivery. A Biomechanical Study Using Optometric Captation (PERFORMAC)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04670380
Acronym
PERFORMAC
Enrollment
40
Registered
2020-12-17
Start date
2021-02-01
Completion date
2021-06-02
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Trauma

Brief 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. 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.

Interventions

OTHERPosture and movement analysis during a simulated forceps vaginal operative delivery

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).

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Medical doctor or registrar that have an experience of operative vaginal delivery using forceps in their clinical activity

Exclusion criteria

* No practice of the forceps at all

Design outcomes

Primary

MeasureTime frameDescription
Analysis of the postures and the movement during the simulated operative vaginal deliveryDay of inclusionmeasures of angles on joints for the different phases of the operative vaginal delivery

Secondary

MeasureTime frameDescription
Analysis of the traction force during the operative deliveryDay of inclusionContinuous measure of the traction force during the delivery (in Newton) thanks to a force sensor implemented in the forceps
Analysis of the postures in terms of stabilityDay of inclusionMeasure of the gravity center projection, the support basis
Compare self-declared practice to the observed practiceDay of inclusionComparison of the postures self-declared in a questionnaire immediately before the simulation to those observed during the simulation

Contacts

Primary ContactBertrand GACHON, MD; PhD Student
bertrand.gachon@chu-poitiers.fr+33549443945

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026