NCT01279889

Brief Summary

This study aims to identify women at risk of low blood pressure (hypotension) after the usual cesarean anesthetic - a spinal anesthetic. Hypotension may be caused by dehydration. We believe we can predict who will get hypotension by using two anesthesia monitors together with a passive leg raise (PLR) (legs elevated after a period spent reclining). The PLR will cause a shift of blood from the legs to the heart, and the monitors will detect the heart's response to tell if a subject is dehydrated. We want to see if these dehydration tests can also predict hypotension after a spinal anesthetic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

January 18, 2011

Last Update Submit

February 10, 2012

Conditions

Hypotension

Keywords

hypotensioncesarean deliverycardiac outputblood pressureplethysmography variability index

Outcome Measures

Primary Outcomes (2)

  • Passive leg raise related cardiac output change and correlation with presence of phenylephrine infusion resistant hypotension

    One hour prior to scheduled cesarean delivery

  • Passive leg raise related plethysmography variability index change and correlation with presence of phenylephrine infusion resistant hypotension

    One hour prior to scheduled cesarean delivery

Secondary Outcomes (8)

  • Baseline plethysmography variability index, plethysmography index and systemic vascular resistance values and correlation with presence of phenylephrine infusion resistant hypotension

    From administration of spinal anesthetic to delivery of infant

  • Passive leg raise related plethysmography variability index and cardiac output change and correlation with severe phenylephrine resistant hypotension

    One hour prior to scheduled cesarean delivery

  • Passive leg raise related plethysmography variability index and cardiac output change and correlation with hypotension associated with bradycardia

    One hour prior to scheduled cesarean delivery

  • Presence of phenylephrine infusion associated side effects

    From administration of spinal anesthetic to delivery of infant

  • Presence of recurrent (3 or more) episodes of phenylephrine infusion associated side effects

    From administration of spinal anesthetic to delivery of infant

  • +3 more secondary outcomes

Study Arms (1)

Cesarean Delivery

Healthy pregnant women having an elective cesarean delivery

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy women who are admitted to the hospital for a scheduled elective cesarean delivery

You may qualify if:

  • Height less than 150cm or greater than 180cm
  • Body Mass Index (BMI) greater than 40kg/m2: obesity makes accurate non-invasive blood pressure (BP) measurement difficult. It may also affect speed of onset and height of subarachnoid block due to increased epidural venous plexus engorgement and thecal sac compression resulting in more marked hypotension.
  • Pregnancy induced hypertension (BP after 20wk greater than 140/90 with proteinuria)
  • High risk of hemorrhage - where fluid volume expansion is planned prior to delivery (e.g. placenta previa, placenta accreta)

You may not qualify if:

  • Starting BP is less than 100 systolic: as the lower limit for intervention defined in this study is 90sys which will likely be within the error of the BP measurement device
  • There is a prolonged (more than 2 hour) wait between testing and spinal insertion: as patients may become more dehydrated affecting hypotension rates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Vit Gunka, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

CA(1)