- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07542197
Pre-anesthetic Teleconsultations During Pregnancy (ECO-CAM)
ECO-CAM: Pre-anesthetic Consultations During Pregnancy: Benefits of Teleconsultation for Patient Assessment, Information, and Ecological Impact
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marion GRITON, MD
- Phone Number: +33 05 57 82 17 22
- Email: marion.griton@chu-bordeaux.fr
Study Contact Backup
- Name: Hela KLAY
- Phone Number: +33 05 40 45 12 34
- Email: hela.klay@chu-bordeaux.fr
Study Locations
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-
-
Bordeaux, France
- CHU de Bordeaux
-
Contact:
- Marion GRITON
- Phone Number: +33 05 57 82 17 22
- Email: marion.griton@chu-bordeaux.fr
-
Principal Investigator:
- Marion GRITON
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teleconsultation
Patients randomized in teleconsultation arm.
|
pre-anesthetic consultation conducted conducted at the Bordeaux University Hospital by an obstetric anesthesia physician using the teleconsultation software provided by the hospital.
|
|
Active Comparator: In-person consultation
Patients randomized in on-site consultation arm
|
In-person consultation conducted at the Bordeaux University Hospital according to the usual procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 weeks after inclusion (pre-anesthetic consultation)
|
|
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" |
at inclusion (pre anesthetic consultation)
|
|
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. |
at inclusion (pre anesthetic consultation)
|
|
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. |
at inclusion (pre anesthetic consultation)
|
|
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.
|
up to 2 month after inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marion GRITON, University Hospital, Bordeaux
- Study Director: Karine NOUETTE-GAULAIN, University Hospital, Bordeaux
- Study Chair: Florence SAILLOUR, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2025/049
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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