NCT03113045

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

March 18, 2017

Last Update Submit

April 9, 2017

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • Hypotension

    Presence of hypotension before delivery

    30 minutes

Study Arms (1)

Seated Time

EXPERIMENTAL

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

Other: seated time

Interventions

seated timeOTHER

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

Seated Time

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with singleton pregnancies scheduled for elective cesarean delivery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mcgill University Health Center

Montreal, Quebec, H2T 1V5, Canada

RECRUITING

Study Officials

  • Albert Moore

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Moore

CONTACT

514 934 1934albert.moore@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The observer will not be made aware of the time that the patient will sit.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 18, 2017

First Posted

April 13, 2017

Study Start

January 31, 2017

Primary Completion

January 31, 2019

Study Completion

January 31, 2020

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)