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

Obstetric Trauma Clinical Trial

— PERFORMAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04670380
• Other study ID #: PERFORMAC
• Status: Not yet recruiting
• Start date: February 1, 2021
• Est. completion date: June 2, 2021

Study information

• Verified date: December 2020
• Source: Poitiers University Hospital
• Contact: Bertrand GACHON, MD; PhD Student
• Phone: +33549443945
• Email: bertrand.gachon[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Trauma

Intervention

Other:
• Posture 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day of inclusion
Secondary	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	Day of inclusion
Secondary	Analysis of the postures in terms of stability	Measure of the gravity center projection, the support basis	Day of inclusion
Secondary	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	Day of inclusion