NCT07542197

Brief Summary

Quality of teleconsultation in comparison to face-to-face consultation for pre anesthetic evaluation in pregnant persons before delivery will be evaluated. Quality is evaluated with a composite criterion comprising 7 elements required for security of anesthesia. Discordance between this composite criterion during the pre anesthesia visit the day of delivery and pre anesthesia consultation several weeks before delivery will be assessed.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
250

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
23mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

April 14, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

pre anesthetic consultationanesthesiaobstetricscarbon footprinte-healthelectronic medical recordstelehealthtelemedicine

Outcome Measures

Primary Outcomes (1)

  • Composite quality criterion

    The primary endpoint will be the discordance between the pre-anesthetic consultation and the pre-anesthetic visit based on a composite quality criterion comprising 7 elements: * Assessment of difficult intubation, defined as a mouth opening \<35 mm * Description of pre-anesthesia medication reconciliation (except therapeutic adjustments in anticoagulants and antidiabetic treatments) * Anesthetic strategy associated with a documented chronic condition if a specific strategy is needed * Adherence to pre-transfusion assessment protocols * Documentation of hematologic assessment in the 6th month, or prescription of assessment in case of absence * Therapeutic approach in case of anemia described * Criteria of difficulty in performing epidural anesthesia This primary criterion will be assessed at the conclusion of the pre-anesthetic visit.

    during pre-anesthetic visit, up to 2 months after inclusion (pre-anesthetic consultation)

Secondary Outcomes (5)

  • Patient satisfaction

    2 weeks after inclusion (pre-anesthetic consultation)

  • Anesthesiologist satisfaction

    at inclusion (pre anesthetic consultation)

  • missed appointment

    at inclusion (pre anesthetic consultation)

  • Epidural anesthesia difficult to perform

    up to 2 month after inclusion

  • Carbon footprint

    at inclusion (pre anesthetic consultation)

Study Arms (2)

Teleconsultation

EXPERIMENTAL

Patients randomized in teleconsultation arm.

Procedure: Teleconsultation

In-person consultation

ACTIVE COMPARATOR

Patients randomized in on-site consultation arm

Procedure: on-site consultation

Interventions

pre-anesthetic consultation conducted conducted at the Bordeaux University Hospital by an obstetric anesthesia physician using the teleconsultation software provided by the hospital.

Teleconsultation

In-person consultation conducted at the Bordeaux University Hospital according to the usual procedure.

In-person consultation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant patients scheduled to give birth at the Bordeaux University Hospital, ASA score 1 or 2, for their primary pregnancy, who have booked an anesthesia appointment on one of the half-days when teleconsultation is available in the department
  • Have access to the internet and functional computer equipment (smartphone, computer)
  • Have a valid email address and telephone number

You may not qualify if:

  • Individuals not affiliated with or beneficiaries of a social security scheme
  • Patients who do not speak French
  • Persons under legal guardianship
  • Psychiatric conditions that impair the ability to consent to or participate in the study
  • Severe spinal pathology (scoliosis requiring a brace or surgery, ankylosing spondylitis), history of spinal surgery
  • Comorbidities with ASA score ≥3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Marion GRITON

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR
  • Karine NOUETTE-GAULAIN

    University Hospital, Bordeaux

    STUDY DIRECTOR
  • Florence SAILLOUR

    University Hospital, Bordeaux

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations