Back to resultsDelayed Positioning in Cesarean Section
Primary Purpose
Hypotension
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lateral positioning
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension
Eligibility Criteria
Inclusion Criteria:
- singleton parturients undergoing elective cesarean section
- gestational age over 37 weeks
Exclusion Criteria:
- pregnancy with hypotension
- expecting fetal depression
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard
lateral
Arm Description
parturients were placed back to the supine position immediately after spinal injection following standard protocol of spinal anesthesia
the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position
Outcomes
Primary Outcome Measures
hypotension
hypotension incidence after intrathecal injection until baby delivery. Monitoring about for 20 minutes
Secondary Outcome Measures
sensory block level
highest sensory block level after intrathecal injection
Full Information
NCT ID
NCT01095315
First Posted
March 22, 2010
Last Updated
April 9, 2010
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01095315
Brief Title
Delayed Positioning in Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
Brief Summary
Maternal hypotension is a common problem during cesarian section under spinal anesthesia. The possible explanation for this is combined aortocaval compression by gravid uterus in parturient in addition to reduced systemic vascular resistance by spinal anesthesia. The investigators evaluated if the incidence of hypotension would be decreased by delayed supine positioning, by maintaining lateral position for 6 min after spinal injection, in patients undergoing elective cesarean section.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard
Arm Type
No Intervention
Arm Description
parturients were placed back to the supine position immediately after spinal injection following standard protocol of spinal anesthesia
Arm Title
lateral
Arm Type
Experimental
Arm Description
the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position
Intervention Type
Other
Intervention Name(s)
lateral positioning
Intervention Description
the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position
Primary Outcome Measure Information:
Title
hypotension
Description
hypotension incidence after intrathecal injection until baby delivery. Monitoring about for 20 minutes
Time Frame
after intrathecal injection until delivery (for 20 minutes)
Secondary Outcome Measure Information:
Title
sensory block level
Description
highest sensory block level after intrathecal injection
Time Frame
during cesarean section
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
singleton parturients undergoing elective cesarean section
gestational age over 37 weeks
Exclusion Criteria:
pregnancy with hypotension
expecting fetal depression
12. IPD Sharing Statement
Learn more about this trial
Delayed Positioning in Cesarean Section
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