Seated Time for Hypotension in Cesarean Delivery: A Biased Coin Design Trial for 90% Efficacy
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’.
Condition:
Cesarean Section Complications
Treatment:
seated time
Start Date:
January 31, 2017
Sponsor:
Royal Victoria Hospital, Canada
For More Information:
https://clinicaltrials.gov/show/NCT03113045