Seated Time for 90% Incidence of Hypotension

Cesarean Section Complications Clinical Trial

Official title:

Seated Time for Hypotension in Cesarean Delivery: A Biased Coin Design Trial for 90% Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03113045
• Other study ID #: 15010MUHC
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2017
• Last updated: April 9, 2017
• Start date: January 31, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2017
• Source: Royal Victoria Hospital, Canada
• Contact: Albert Moore
• Phone: 514 934 1934
• Email: albert.moore[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will determine the 90% effective seated time after intrathecal injection of hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.

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'.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hypotension

Intervention

Other:
• seated time
Pt will be seated for a predetermined time period. All Patients will receive intrathecal bupivacaine and morphine.

Locations

Country	Name	City	State
Canada	Mcgill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Royal Victoria Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension	Presence of hypotension before delivery	30 minutes