CClinicalTrials.gg
Status unknownNCT03113045Updated Apr 13, 2017

Seated Time for 90% Incidence of Hypotension

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 sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
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Study summary

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

Read the 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'.

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Conditions studied

  • Cesarean Section Complications

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03

In context

Hypotension

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with singleton pregnancies scheduled for elective cesarean delivery

Exclusion criteria

Exclusion Criteria:

  • BMI>35
  • Unable to communicate in study language
  • ASA greater than 2
  • Hypertensive disease of pregnancy
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Seated Time

    Pts will be seated for the allocated time depending on the previous patients hypotensive response

    Other: seated time

Interventions

  • Otherseated time

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

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What researchers measure

Primary outcomes

  1. Hypotension

    Presence of hypotension before delivery

    Time frame: 30 minutes

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Study locations

1 of 1 sites recruiting
  • Mcgill University Health Center
    Montreal, Quebec H2T 1V5, Canada
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03113045
Lead sponsor
Royal Victoria Hospital, Canada
Responsible party
Albert Moore (Principle Investigator, Royal Victoria Hospital, Canada) — Principal investigator
First posted
Apr 13, 2017
Start date
Jan 31, 2017
Primary completion
Jan 31, 2019 (estimated)
Completion
Jan 31, 2020 (estimated)
Last update
Apr 13, 2017

Study contacts

Albert Moore
Contact
albert.moore@mcgill.ca
514 934 1934 ext. 34880
Albert Moore
principal investigator · McGill University Health Centre/Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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