NCT05975411

Brief Summary

Pilot study in Lower Normandy concerning a total of 90 patients scheduled for a pre-anaesthesia consultation in obstetrics. These parturients who plan to give birth at the maternity hospital of the CHU will be invited to carry out their anesthesia consultation with a view to childbirth either by way of the telemedicine cabin installed in Dozulé, or by way of the telemedicine trolley installed in a center close to their place of residence, or at the CHU de Caen as usual. The validation of the adequacy of the possibilities of telemedicine with the requirements of the anesthesia consultation worked upstream is the main objective of this work, the appreciation of the parturient at this consultation, the appreciation of the consulting and validating professionals will also be collected with the aim of a maximum optimization of this new offer intended for the region.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
Last Updated

March 10, 2026

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 25, 2023

Last Update Submit

March 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of the airways via a telemedicine device

    * Composite score (rated from 5 to 14) evaluating the risk of difficult orotracheal intubation which is based on the five main elements of the airway evaluation during the anesthesia consultation which are: * Mouth opening * Mallampati score * Cervical spine mobility * Thyro-chin distance * Patient Profile * Lip test

    baseline

Study Arms (3)

telemedecine cabin

Anesthesia Consultation with telemedicine cabin installed in Dozulé

Other: Anesthesia Consultation with telemedicine

telemedicine trolley

Anesthesia Consultation with telemedicine by way of the telemedicine trolley installed in a center close to their place of residence

Other: Anesthesia Consultation with telemedicine

standard

Anesthesia Consultation at the CHU de Caen as usual.

Interventions

Anesthesia Consultation with telemedicine

telemedecine cabintelemedicine trolley

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnancy women

You may qualify if:

  • Pregnant woman
  • over 18 years old
  • beneficiary of social security/CMU
  • Non-emergency pre-anesthesia consultation
  • delivery planned at the maternity ward of the University Hospital of Caen
  • living in the vicinity of Dozulé or living near an establishment with a telemedicine cart equipped with the necessary equipment
  • Having received clear and honest information about the study, and having given their consent
  • Having given their consent for a telemedicine consultation
  • patient without comorbidity

You may not qualify if:

  • Patient refusal
  • Patient under guardianship
  • Patient with psychomotor disability; hearing impaired; visually impaired
  • Difficulties in understanding information, expression; foreign language
  • Pathological pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAEN University Hospital

Caen, France

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 3, 2023

Study Start

January 11, 2021

Primary Completion

March 15, 2021

Study Completion

December 31, 2021

Last Updated

March 10, 2026

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations