Effects of; Anesthesia, Spinal and Epidural, in PregnancyNCT03488277
Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section
A study testing leg elevation in people with Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups: LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
- What is being tested?
- leg elevation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTunisia
- Study dates
- 10 Jan 2018to 31 Dec 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- full term parturients
- age> 18 Y
- scheduled of elective or urgent cesarean section under spinal anesthesia
Who cannot join
- patients who had general anesthesia
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Mongi Slim Hospital
La Marsa, Tunis Governorate, 2046
Mhamed Sami Mebazaa, professor, 0021622252589, msmebazaa@gmail.com
About this study
Official title: Evaluation of the Efficiency of Leg Elevation for Preventing Post Spinal Hypotension in Cesarean Section
Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:
LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.
Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil.
Read the detailed description
Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:
LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.
Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil. we will record the demographic data, pre and intraoperative hemodynamic parameters, the dose of ephedrine required to treat post spinal hypotension and fetal parameters: pH and blood lactates
- Being tested
- leg elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg elevationOther
intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels
| Study group | Role | What they receive |
|---|---|---|
| LE: leg elevation group | Experimental | the patients of this group will be positionned in supine with 15° left tilt and will have a leg elevation with a 30 cm pillow positionned under the heels. this position will be hold immediately after spinal anesthesia until fetal extraction Receives: Other: leg elevation |
| CG: Control group | No intervention | The patients of this group will be positiooned in supine with 15° left tlit after spinal anesthesia. no leg elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post spinal hypotension
change of systolic blood pressure from baseline< 90 mmHg
Measured: during the first 30minutes after the spinal anesthesia
Secondary outcomes (4)
Lowest systolic blood pressure
the lowest systolic blood pressure observed after spinal anesthesia
Measured: during the first 30 minutes following spinal anesthesia
ephedrine consumption
total dose of Ephedrine received to treat post spinal hypotension
Measured: during the first 30 minutes following the spinal anesthesia
Fetal ph
fetal ph measured with blood gas analysis
Measured: 30 minutes after spinal anesthesia
Fetal blood lactates
fetal blood lactates (mmol/L) measured with blood gas analysis
Measured: 30 minutes after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start10 Jan 2018
- Primary completion22 Mar 2018
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of; Anesthesia, Spinal and Epidural, in PregnancyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Mhamed Sami Mebazaa, Professor, Principal investigator, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488277
- Sponsor's protocol ID
- Mater1
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 4 Apr 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 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Leg Elevation for Preventing Post Spinal Hypotension in Cesarean Section
- ClinicalTrials.gov ID
- NCT03488277
- Acronym / sponsor ID
- Mater1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 4 Apr 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.
Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:
LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.
Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil.
Detailed description
Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:
LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.
Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil. we will record the demographic data, pre and intraoperative hemodynamic parameters, the dose of ephedrine required to treat post spinal hypotension and fetal parameters: pH and blood lactates
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LE: leg elevation group | Experimental | Other: leg elevationthe patients of this group will be positionned in supine with 15° left tilt and will have a leg elevation with a 30 cm pillow positionned under the heels. this position will be hold immediately after spinal anesthesia until fetal extraction |
| CG: Control group | No intervention | –The patients of this group will be positiooned in supine with 15° left tlit after spinal anesthesia. no leg elevation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- full term parturients
- age> 18 Y
- scheduled of elective or urgent cesarean section under spinal anesthesia
Key exclusion criteria (1 listed)
- patients who had general anesthesia
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 |
|---|---|---|
| leg elevationintra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels | Other | LE: leg elevation group |
Primary outcome
Incidence of post spinal hypotension
Time frame: during the first 30minutes after the spinal anesthesia
change of systolic blood pressure from baseline< 90 mmHg
4 secondary outcomes
Lowest systolic blood pressure
Time frame: during the first 30 minutes following spinal anesthesia
ephedrine consumption
Time frame: during the first 30 minutes following the spinal anesthesia
Fetal ph
Time frame: 30 minutes after spinal anesthesia
Fetal blood lactates
Time frame: 30 minutes after spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Individual participant dataSharing planned: Undecided
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.
Mhamed Sami Mebazaa, Professor principal investigator
Mongi Slim Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leg elevation in people with Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by Mongi Slim Hospital at 1 site in Tunisia.
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 1 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 4 Apr 2018. 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 Tunisia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mhamed Sami Mebazaa, professor (0021622252589, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post spinal hypotension (time frame: during the first 30minutes after the spinal anesthesia). 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 4 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.