NCT04608227

Brief Summary

Spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases. Our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45° passive leg raising to predict hypotension after spinal anaesthesia. Systolic ejection volum was monitored with non-invasive Clearsight Device just before elective caesarean section in third trimester pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

October 19, 2020

Last Update Submit

August 2, 2022

Conditions

HypotensionPregnancy RelatedSpinal Anesthetics Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (1)

  • Systolic Ejection volume (mL)

    Systolic ejection volume is measured using Clearsight (non invasive monitoring device)

    30 minutes

Secondary Outcomes (1)

  • Velocity - Time - Integral (cm)

    30 minutes

Study Arms (1)

Third trimester pregnant women undergoing ceasarean section

Device: Clearsight monitoring

Interventions

Clearsight monitoringDEVICE

Non invasive hemodynamic monitoring using a finger cuff Cardiac ultrasound performed to calculate Velocity - Time - integral (VTI) Both intervention are performed before and after a passive leg raising challenge.

Also known as: Cardiac ultrasound
Third trimester pregnant women undergoing ceasarean section

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregmant women
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

prospective inclusion of 3 rd trimester pregnant women undergoing spinal anesthesia for elective ceasarean section

You may qualify if:

  • third trimester pregnant women undergoing elective ceasarean section under spinal anesthesia

You may not qualify if:

  • emergent ceasarean section
  • eclampsia or pre-eclampsia
  • undergoing anti-hypertensive treatment
  • arythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement anesthesie reanimation hopital nord

Marseille, 13015, France

Location

Related Links

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 29, 2020

Study Start

June 1, 2020

Primary Completion

November 26, 2020

Study Completion

February 15, 2021

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)