An interventional study of seated time in Cesarean Section Complications, sponsored by Royal Victoria Hospital, Canada. Status unknown at 1 site in Canada. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by Royal Victoria Hospital, Canada · Not applicable, Interventional, and Prevention
The study will determine the 90% effective seated time after intrathecal injection of hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.
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'.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Royal Victoria Hospital, Canada is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pts will be seated for the allocated time depending on the previous patients hypotensive response
Other: seated time
Pt will be seated for a predetermined time period. All Patients will receive intrathecal bupivacaine and morphine.
Hypotension
Presence of hypotension before delivery
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Royal Victoria Hospital, Canada