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Not yet recruiting NCT07542197

Pre-anesthetic Teleconsultations During Pregnancy

No phase Interventional Pregnancy Anesthesia Satisfaction Telemedicine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Teleconsultation, on-site consultation.
Who it may be relevant to
Registry conditions: Pregnancy, Anesthesia, Satisfaction, Telemedicine. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ECO-CAM: Pre-anesthetic Consultations During Pregnancy: Benefits of Teleconsultation for Patient Assessment, Information, and Ecological Impact

Overview

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.

Detailed description

In the third trimester of pregnancy, pre-anesthetic consultations are mandatory before childbirth, typically recommended between 32 and 36 weeks of gestation. These consultations assess risks associated with anesthesia and childbirth while providing information on anesthetic options, including neuraxial anesthesia. Since 2009, consultations can be conducted on-site or via teleconsultation. However, the quality of teleconsultations and patient satisfaction have not been evaluated in an obstetric context.

This study consists of two patient groups assigned following randomization:

* Teleconsultation: conducted at Bordeaux University Hospital by an obstetric anesthesia physician using the teleconsultation software provided by the hospital. * In-person consultation: conducted at Bordeaux University Hospital according to the usual procedure.

Following patient enrollment, the follow-up protocol proceeds as outlined below:

* Day -56 to Day -28: Patients with scheduled anesthesia appointments during designated teleconsultation periods are contacted. They are briefed about the study and provided with consent documents via email or in person if they opt to participate. * Day -56 to Day -10: Upon receipt of signed consent forms, patients undergo randomization. If necessary, their initial appointment is adjusted according to the assigned group. The rescheduled appointment is arranged for the same designated time slot, with timing aligned as closely as possible to the original appointment. For teleconsultation participants, the secretary sends anesthesia-related informational materials and instructions for connecting to the teleconsultation software. * Day 0: Pre-anesthetic consultations are conducted based on the assigned randomization modality (in-person or teleconsultation). * Day 14: Satisfaction and transportation modality questionnaires are distributed via email. * Upon childbirth, a pre-anesthetic visit is conducted.

Interventions

  • Procedure Teleconsultation
    pre-anesthetic consultation conducted conducted at the Bordeaux University Hospital by an obstetric anesthesia physician using the teleconsultation software provided by the hospital.
  • Procedure on-site consultation
    In-person consultation conducted at the Bordeaux University Hospital according to the usual procedure.

Primary outcome measures

  • Composite quality criterion [Time frame: during pre-anesthetic visit, up to 2 months after inclusion (pre-anesthetic consultation)]
Secondary outcome measures (5)
  • Patient satisfaction [Time frame: 2 weeks after inclusion (pre-anesthetic consultation)]
  • Anesthesiologist satisfaction [Time frame: at inclusion (pre anesthetic consultation)]
  • missed appointment [Time frame: at inclusion (pre anesthetic consultation)]
  • Epidural anesthesia difficult to perform [Time frame: up to 2 month after inclusion]
  • Carbon footprint [Time frame: at inclusion (pre anesthetic consultation)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Minor patient (under 18 years old at the time of inclusion)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • CHU de Bordeaux — Bordeaux

Identifiers

NCT: NCT07542197 · CHUBX 2025/049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗