Pregnancy RelatedCATmedONCT05975411
Telemedicine Anesthesia Consultation, Pilot Study in Obstetrics.
An observational study of Pregnancy Related, run by University Hospital, Caen at 1 site in France.
Trial summary
Pilot study in Lower Normandy concerning a total of 90 patients scheduled for a pre-anaesthesia consultation in obstetrics. These parturients who plan to give birth at the maternity hospital of the CHU will be invited to carry out their anesthesia consultation with a view to childbirth either by way of the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Anesthesia Consultation with telemedicine
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: pregnancy women
Who may be able to join
- Pregnant woman
- over 18 years old
- beneficiary of social security/CMU
- Non-emergency pre-anesthesia consultation
- delivery planned at the maternity ward of the University Hospital of Caen
- living in the vicinity of Dozulé or living near an establishment with a telemedicine cart equipped with the necessary equipment
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- Having received clear and honest information about the study, and having given their consent
- Having given their consent for a telemedicine consultation
- patient without comorbidity
Who cannot join
- Patient refusal
- Patient under guardianship
- Patient with psychomotor disability; hearing impaired; visually impaired
- Difficulties in understanding information, expression; foreign language
- Pathological pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Pilot study in Lower Normandy concerning a total of 90 patients scheduled for a pre-anaesthesia consultation in obstetrics. These parturients who plan to give birth at the maternity hospital of the CHU will be invited to carry out their anesthesia consultation with a view to childbirth either by way of the telemedicine cabin installed in Dozulé, or by way of the telemedicine trolley installed in a center close to their place of residence, or at the CHU de Caen as usual.
The validation of the adequacy of the possibilities of telemedicine with the requirements of the anesthesia consultation worked upstream is the main objective of this work, the appreciation of the parturient at this consultation, the appreciation of the consulting and validating professionals will also be collected with the aim of a maximum optimization of this new offer intended for the region.
- Conditions
- Pregnancy Related
- Being tested
- Anesthesia Consultation with telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia Consultation with telemedicineOther
Anesthesia Consultation with telemedicine
| Study group | Role | What they receive |
|---|---|---|
| telemedecine cabin | Anesthesia Consultation with telemedicine cabin installed in Dozulé Receives: Other: Anesthesia Consultation with telemedicine | |
| telemedicine trolley | Anesthesia Consultation with telemedicine by way of the telemedicine trolley installed in a center close to their place of residence Receives: Other: Anesthesia Consultation with telemedicine | |
| standard | Anesthesia Consultation at the CHU de Caen as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the airways via a telemedicine device
- Composite score (rated from 5 to 14) evaluating the risk of difficult orotracheal intubation which is based on the five main elements of the airway evaluation during the anesthesia consultation which are:
- Mouth opening
- Mallampati score
- Cervical spine mobility
- Thyro-chin distance
- Patient Profile
- Lip test
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start11 Jan 2021
- Primary completion15 Mar 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975411
- Sponsor's protocol ID
- 18-180
- Acronym
- CATmedO
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Anesthesia Consultation, Pilot Study in Obstetrics.
- ClinicalTrials.gov ID
- NCT05975411
- Acronym / sponsor ID
- CATmedO / 18-180
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Aug 2023 (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.
Pilot study in Lower Normandy concerning a total of 90 patients scheduled for a pre-anaesthesia consultation in obstetrics. These parturients who plan to give birth at the maternity hospital of the CHU will be invited to carry out their anesthesia consultation with a view to childbirth either by way of the telemedicine cabin installed in Dozulé, or by way of the telemedicine trolley installed in a center close to their place of residence, or at the CHU de Caen as usual.
The validation of the adequacy of the possibilities of telemedicine with the requirements of the anesthesia consultation worked upstream is the main objective of this work, the appreciation of the parturient at this consultation, the appreciation of the consulting and validating professionals will also be collected with the aim of a maximum optimization of this new offer intended for the region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| telemedecine cabin | – | Other: Anesthesia Consultation with telemedicineAnesthesia Consultation with telemedicine cabin installed in Dozulé |
| telemedicine trolley | – | Other: Anesthesia Consultation with telemedicineAnesthesia Consultation with telemedicine by way of the telemedicine trolley installed in a center close to their place of residence |
| standard | – | –Anesthesia Consultation at the CHU de Caen as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnancy women
Key inclusion criteria (9 listed)
- Pregnant woman
- over 18 years old
- beneficiary of social security/CMU
- Non-emergency pre-anesthesia consultation
- delivery planned at the maternity ward of the University Hospital of Caen
Key exclusion criteria (5 listed)
- Patient refusal
- Patient under guardianship
- Patient with psychomotor disability; hearing impaired; visually impaired
- Difficulties in understanding information, expression; foreign language
- Pathological pregnancy
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 |
|---|---|---|
| Anesthesia Consultation with telemedicineAnesthesia Consultation with telemedicine | Other | telemedecine cabin, telemedicine trolley |
Primary outcome
assessment of the airways via a telemedicine device
Time frame: baseline
* Composite score (rated from 5 to 14) evaluating the risk of difficult orotracheal intubation which is based on the five main elements of the airway evaluation during the anesthesia consultation which are: * Mouth opening * Mallampati score * Cervical spine mobility * Thyro-chin distance * Patient Profile * Lip test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by University Hospital, Caen 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the airways via a telemedicine device (time frame: baseline). 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 10 Mar 2026; AzTrials last refreshed its copy on 3 Nov 2026.