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NCT Number: NCT07542197

Pre-anesthetic Teleconsultations During Pregnancy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teleconsultation

Procedure

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

on-site consultation

Procedure

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

Primary outcomes

  1. Composite quality criterion

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

    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.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 2 weeks after inclusion (pre-anesthetic consultation)

    This questionnaire will include an overall assessment based on the question: "To what extent are you satisfied with your appointment with the anesthesiologist?", rated on a 5-point Likert scale (Very satisfied / Somewhat satisfied / Neither satisfied nor dissatisfied / Somewhat dissatisfied / Very dissatisfied) The remainder of the questionnaire will be developed for this study based on the validated CARE questionnaire.

    The CARE questionnaire is a tool developed by Stewart W. Mercer, initially for general practice, and validated in 2004. It focuses on the empathy patients perceive during consultations. It consists of 10 questions, rated on Likert scales.

  2. Anesthesiologist satisfaction

    Time frame: at inclusion (pre anesthetic consultation)

    The experience of telemedicine consultations by anesthesiologists will be evaluated at the end of each half-day of consultations. Anesthesiologists and intensivists will be asked to complete a questionnaire consisting of 6 questions:

    Each response will be rated on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree"

  3. missed appointment

    Time frame: at inclusion (pre anesthetic consultation)

    A missed appointment is defined as the failure to conduct a pre-anesthetic consultations on the scheduled day due to the patient's absence or tardiness at the time of the appointment.

    Data on missed appointments will be collected for each patient included in the study.

    The rate of missed or rescheduled appointments will be calculated for each group.

  4. Epidural anesthesia difficult to perform

    Time frame: up to 2 month after inclusion

    The number of epidural anesthesias that are difficult to administer will be recorded. The criteria used to define a difficult administration are: more than three attempts at puncture or the involvement of a second practitioner.

  5. Carbon footprint

    Time frame: at inclusion (pre anesthetic consultation)

    The study will assess the carbon footprint of pre-anesthesia teleconsultations compared to in-person consultations by estimating greenhouse gas emissions associated with transportation.

    The carbon footprint of teleconsultations will be calculated using the emissions factor per minute of viewing time for teleconsultations, which depends on the energy consumption of the internet network and the carbon footprint of the internet infrastructure.

Study contacts

Contact information is provided by the study sponsor or research team.

Hela KLAY

CONTACT

[email protected]

05 40 45 12 34 ext. +33

Marion GRITON, MD

CONTACT

[email protected]

05 57 82 17 22 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: ECO-CAM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 21, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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