Seated Time for 90% Incidence of Hypotension
Primary Purpose
Cesarean Section Complications
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
seated time
Sponsored by
About this trial
This is an interventional prevention trial for Cesarean Section Complications
Eligibility Criteria
Inclusion Criteria:
- Patients with singleton pregnancies scheduled for elective cesarean delivery
Exclusion Criteria:
- BMI>35
- Unable to communicate in study language
- ASA greater than 2
- Hypertensive disease of pregnancy
Sites / Locations
- Mcgill University Health CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Seated Time
Arm Description
Pts will be seated for the allocated time depending on the previous patients hypotensive response
Outcomes
Primary Outcome Measures
Hypotension
Presence of hypotension before delivery
Secondary Outcome Measures
Full Information
NCT ID
NCT03113045
First Posted
March 18, 2017
Last Updated
April 9, 2017
Sponsor
Royal Victoria Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT03113045
Brief Title
Seated Time for 90% Incidence of Hypotension
Official Title
Seated Time for Hypotension in Cesarean Delivery: A Biased Coin Design Trial for 90% Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
January 31, 2019 (Anticipated)
Study Completion Date
January 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Victoria Hospital, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will determine the 90% effective seated time after intrathecal injection of hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.
Detailed Description
The study will use a Biased Coin Design (BCD), up-and-down sequential method, to determine the ET90 for absence of hypotension during Cesarean delivery. In this methodology, the first patient will be assigned an a priori initial seated time. Any other patient will be assigned a seated time based on the presence or absence of hypotension in the previous patient. If the previous patient developed hypotension, then the new patient will be seated for a longer time, which will be equal to the seated time of the previous patient plus a pre-determined time increment (up to an also pre-determined maximum allowed time). If no hypotension occurred to the previous patient, the new patient will be assigned one seated time from two choices: The same seated time that has been assigned to the previous patient, or a seated time shorter than that of the previous patient by a pre-determined time decrement (the pre-determined time increment and decrement are the same). The choice will be determined from a biased coin result, with a probability of 0.9 for assigning 'the same as previous' seated time and a probability of 0.1 for assigning a 'shorter seated time'.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The observer will not be made aware of the time that the patient will sit.
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Seated Time
Arm Type
Experimental
Arm Description
Pts will be seated for the allocated time depending on the previous patients hypotensive response
Intervention Type
Other
Intervention Name(s)
seated time
Intervention Description
Pt will be seated for a predetermined time period. All Patients will receive intrathecal bupivacaine and morphine.
Primary Outcome Measure Information:
Title
Hypotension
Description
Presence of hypotension before delivery
Time Frame
30 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with singleton pregnancies scheduled for elective cesarean delivery
Exclusion Criteria:
BMI>35
Unable to communicate in study language
ASA greater than 2
Hypertensive disease of pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albert Moore
Phone
514 934 1934
Ext
34880
Email
albert.moore@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Moore
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mcgill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2T 1V5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Moore
Phone
5139341934
Ext
34880
Email
moore_albert@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Seated Time for 90% Incidence of Hypotension
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