PregnancyECO-CAMNCT07542197
Pre-anesthetic Teleconsultations During Pregnancy
A study testing Teleconsultation and on-site consultation in people with Pregnancy and Anesthesia, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Anesthesia, Satisfaction
- What is being tested?
- Teleconsultation and on-site consultation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Bordeaux
Bordeaux
Marion GRITON, 05 57 82 17 22 ext. +33, marion.griton@chu-bordeaux.fr
Marion GRITON
About this study
Official title: ECO-CAM: Pre-anesthetic Consultations During Pregnancy: Benefits of Teleconsultation for Patient Assessment, Information, and Ecological Impact
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.
Read the 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.
- Conditions
- Pregnancy, Anesthesia, Satisfaction, Telemedicine
- Being tested
- Teleconsultation, on-site consultation
- Keywords
- pre anesthetic consultation, anesthesia, obstetrics, carbon footprint, e-health, electronic medical records, telehealth, telemedicine
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconsultationProcedure or surgery
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 consultationProcedure or surgery
In-person consultation conducted at the Bordeaux University Hospital according to the usual procedure.
| Study group | Role | What they receive |
|---|---|---|
| Teleconsultation | Experimental | Patients randomized in teleconsultation arm. Receives: Procedure: Teleconsultation |
| In-person consultation | Active comparator | Patients randomized in on-site consultation arm Receives: Procedure: on-site consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during pre-anesthetic visit, up to 2 months after inclusion (pre-anesthetic consultation)
Secondary outcomes (5)
Patient satisfaction
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.
Measured: 2 weeks after inclusion (pre-anesthetic consultation)
Anesthesiologist satisfaction
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"
Measured: at inclusion (pre anesthetic consultation)
missed appointment
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.
Measured: at inclusion (pre anesthetic consultation)
Epidural anesthesia difficult to perform
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.
Measured: up to 2 month after inclusion
Carbon footprint
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.
Measured: at inclusion (pre anesthetic consultation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start30 Jun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion GRITON, Principal investigator, University Hospital, BordeauxKarine NOUETTE-GAULAIN, Study director, University Hospital, BordeauxFlorence SAILLOUR, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542197
- Sponsor's protocol ID
- CHUBX 2025/049
- Acronym
- ECO-CAM
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECO-CAM: Pre-anesthetic Consultations During Pregnancy: Benefits of Teleconsultation for Patient Assessment, Information, and Ecological Impact
- ClinicalTrials.gov ID
- NCT07542197
- Acronym / sponsor ID
- ECO-CAM / CHUBX 2025/049
- Conditions
- Pregnancy, Anesthesia, Satisfaction, Telemedicine
- Keywords
- pre anesthetic consultation, anesthesia, obstetrics, carbon footprint, e-health, electronic medical records, telehealth, telemedicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teleconsultation | Experimental | Procedure: TeleconsultationPatients randomized in teleconsultation arm. |
| In-person consultation | Active comparator | Procedure: on-site consultationPatients randomized in on-site consultation arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teleconsultationpre-anesthetic consultation conducted conducted at the Bordeaux University Hospital by an obstetric anesthesia physician using the teleconsultation software provided by the hospital. | Procedure or surgery | Teleconsultation |
| on-site consultationIn-person consultation conducted at the Bordeaux University Hospital according to the usual procedure. | Procedure or surgery | In-person consultation |
Primary outcome
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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marion GRITON principal investigator
University Hospital, Bordeaux
Karine NOUETTE-GAULAIN study director
University Hospital, Bordeaux
Florence SAILLOUR study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation and on-site consultation in people with Pregnancy and Anesthesia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion GRITON, MD (05 57 82 17 22 ext. +33, marion.griton@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite quality criterion (time frame: during pre-anesthetic visit, up to 2 months after inclusion (pre-anesthetic consultation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.