Cesarean SectionNCT03730090
Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia
An observational study of Cesarean Section, run by Oslo University Hospital.
Trial summary
To study the core temperature perioperatively in patients due for elective cesarean sectio in spinal anaesthesia. Core temperature will be registered by a zero-flux (SpotOn. 3m) probe on the forehead, starting in the holding area and continued until normotemperature post-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- zero flux skin termometer
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Dec 2019
- 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: consecutive, elective cesarean sectio
Who may be able to join
- Elective patients
- planned spinal anaesthesia
Who cannot join
- Conversion of procedure to general anaesthesia
- allergy to temperature probe (adhesive)
About this study
To study the core temperature perioperatively in patients due for elective cesarean sectio in spinal anaesthesia.
Core temperature will be registered by a zero-flux (SpotOn. 3m) probe on the forehead, starting in the holding area and continued until normotemperature post-operatively.
- Conditions
- Cesarean Section
- Being tested
- zero flux skin termometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zero flux skin termometerDevice
Core temperature is monitored continously, non-invasively
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of perioperative hypothermia, less than 36.0 degrees
mesured by zero flux in forehead
Measured: perioperatively
Secondary outcomes (3)
patient satisfaction: Patient will be asked to grade
Patient will be asked to grade their feeling of being Cold/warm
Measured: perioperatively, repeated
duration of perioperative hypothermia
number of minutes below 36.0 degrees
Measured: perioperatively, continously
shivering
any shivering due to being cold
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan C Ræder, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730090
- Sponsor's protocol ID
- Hypothermia Sectio OUS
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia
- ClinicalTrials.gov ID
- NCT03730090
- Acronym / sponsor ID
- Hypothermia Sectio OUS
- Conditions
- Cesarean Section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Nov 2018 (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.
To study the core temperature perioperatively in patients due for elective cesarean sectio in spinal anaesthesia.
Core temperature will be registered by a zero-flux (SpotOn. 3m) probe on the forehead, starting in the holding area and continued until normotemperature post-operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive, elective cesarean sectio
Key inclusion criteria (2 listed)
- Elective patients
- planned spinal anaesthesia
Key exclusion criteria (2 listed)
- Conversion of procedure to general anaesthesia
- allergy to temperature probe (adhesive)
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 |
|---|---|---|
| zero flux skin termometerCore temperature is monitored continously, non-invasively | Device | – |
Primary outcome
incidence of perioperative hypothermia, less than 36.0 degrees
Time frame: perioperatively
mesured by zero flux in forehead
3 secondary outcomes
patient satisfaction: Patient will be asked to grade
Time frame: perioperatively, repeated
duration of perioperative hypothermia
Time frame: perioperatively, continously
shivering
Time frame: perioperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section, run by Oslo University Hospital.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
incidence of perioperative hypothermia, less than 36.0 degrees (time frame: perioperatively). 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 5 Nov 2018.