Clinical Trials Logo
  1. Home
  2. Pregnancy Related
  3. NCT04608227
  4. Details
NCT04608227 Clinical Trial

Non-invasive Haemodynamic Monitoring to Predict Spinal Hypotension During Caesarian Section

Pregnancy Related Clinical Trial

Official title:
Can Non-invasive Haemodynamic Monitoring With Clearsight(r) Predict Spinal Hypotension During Caesarian Section? A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04608227
Other study ID # Darnord-2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date February 15, 2021

Study information
Verified date August 2022
Source Hospital Nord
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 15, 2021
Est. primary completion date November 26, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - third trimester pregnant women undergoing elective ceasarean section under spinal anesthesia Exclusion Criteria: - emergent ceasarean section - eclampsia or pre-eclampsia - undergoing anti-hypertensive treatment - arythmia

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Clearsight monitoring
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.

Locations
Country Name City State
France Departement anesthesie reanimation hopital nord Marseille

Sponsors (1)
Lead Sponsor Collaborator
Hospital Nord

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Systolic Ejection volume (mL) Systolic ejection volume is measured using Clearsight (non invasive monitoring device) 30 minutes
Secondary Velocity - Time - Integral (cm) Velocity - Time - Integral is measured using transthoracic cardiac ultrasound 30 minutes
See also
  Status Clinical Trial Phase
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT06258902 - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed NCT05487196 - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia Phase 2
Completed NCT03750968 - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects Phase 2
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT06069869 - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06069856 - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06079918 - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania Phase 3
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A

External Links