Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section
Evaluation of the Efficiency of Leg Elevation for Preventing Post Spinal Hypotension in Cesarean Section
1 other identifier
interventional
200
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2018
CompletedFirst Submitted
Initial submission to the registry
March 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2018
CompletedFirst Posted
Study publicly available on registry
April 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedApril 4, 2018
March 1, 2018
2 months
March 22, 2018
March 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of post spinal hypotension
change of systolic blood pressure from baseline\< 90 mmHg
during the first 30minutes after the spinal anesthesia
Secondary Outcomes (4)
Lowest systolic blood pressure
during the first 30 minutes following spinal anesthesia
ephedrine consumption
during the first 30 minutes following the spinal anesthesia
Fetal ph
30 minutes after spinal anesthesia
Fetal blood lactates
30 minutes after spinal anesthesia
Study Arms (2)
LE: leg elevation group
EXPERIMENTALthe 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 INTERVENTIONThe patients of this group will be positiooned in supine with 15° left tlit after spinal anesthesia. no leg elevation
Interventions
intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels
Eligibility Criteria
You may qualify if:
- full term parturients
- age\> 18 Y
- scheduled of elective or urgent cesarean section under spinal anesthesia
You may not qualify if:
- patients who had general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mongi Slim Hospital
La Marsa, Tunis Governorate, 2046, Tunisia
Study Officials
- PRINCIPAL INVESTIGATOR
Mhamed Sami Mebazaa, Professor
Mongi Slim Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor head of the anesthesia and intensive care department
Study Record Dates
First Submitted
March 22, 2018
First Posted
April 4, 2018
Study Start
January 10, 2018
Primary Completion
March 22, 2018
Study Completion
December 31, 2018
Last Updated
April 4, 2018
Record last verified: 2018-03