Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study (CesAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04719819
Recruitment Status : Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Most of caesarean sections can be performed under spinal anaesthesia. Its major advantages are reliability and fast onset. However, dose of hyperbaric bupivacaine used, combination with adjuvants, hemodynamic management, and impact of these measures on maternal experience are not uniform. This study aims to describe practices of spinal anaesthesia for caesarean section in France to improve practices, guide new studies and establish protocols.

Condition or disease Intervention/treatment
Anesthesia, Spinal Nonemergency Cesarean Section Procedure: Spinal anaesthesia for caesarean section

Detailed Description:

Most of caesarean sections can be performed under spinal anaesthesia. Its major advantages are reliability and fast onset. However, techniques of spinal anaesthesia are varied. Dose of hyperbaric bupivacaine used may shifted, varying intensity of sensor block but also hemodynamic side effect. Likewise, use of adjuvant is frequent and differs between centres. Management of the maternal hemodynamic is also discussed. While it is recognized that intraoperatively vascular filling alone is not effective, use of vasopressors is not unequivocal. For example, recent studies support the use of norepinephrine.

Finally, maternal experience is a hot topic. Although insufficient anaesthesia is rare, it is often overlooked. There are few recommendations on the intraoperative treatment of insufficient anaesthesia and to the management of post-traumatic stress that it lead to.

The objective of this study is to describe practices of spinal anaesthesia for scheduled or non-emergency caesarean section (also named "green code") in France by detailing several points:

Technique of spinal anaesthesia:

  • The anaesthesia solution used (doses and adjuvants)
  • Management of hemodynamic
  • Management of insufficient anaesthesia
  • Maternal experience It aims to make an inventory of practices, to orient future studies, guide practice and the realization of protocols.

It is an observational study unfolds from 2021 to 2022. It concerns 11 French centres and 600 women. Data are collected with an online questionnaire.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study
Estimated Study Start Date : January 31, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Usual pratice
Assessment of usual practices
 Procedure: Spinal anaesthesia for caesarean section
Descriptive questionnaire with open and closed questions, to be completed during the procedure


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Maternal data [ Time Frame: Day of surgery ]
    Ad hoc Questionnaire

  2. Obstetrical data [ Time Frame: Day of surgery ]
    Ad hoc Questionnaire

  3. Spinal procedure [ Time Frame: Day of surgery ]
    Ad hoc Questionnaire

  4. Haemodynamic management [ Time Frame: Day of surgery ]
    Ad hoc Questionnaire

  5. Maternal experience [ Time Frame: Day of surgery ]
    Ad hoc Questionnaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with spinal anaesthesia scheduled or non-emergency caesarean section
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • Affiliation to social security system
  • Scheduled or elective Caesarean section (green code) under spinal anesthesia

Exclusion Criteria:

  • Refusal to participate in the study
  • Code red Caesarean section or general anesthesia decision
  • Complicated" Caesarean section or combined spinal-epidural technique
  • Presence of an epidural catheter
  • Performing a combined spinal-epidural technique (even if the epidural catheter is not used)
  • Contraindication to spinal anaesthesia (coagulation disorder, vertebral-medullary pathologies)
  • Patient under guardianship or curatorship
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719819


Contacts
Layout table for location contacts
Contact: Lise Laclautre +33 4 73 754963 promo_interne_drci@chu-clermontferrand.fr
Contact: Martine Bonnin mbonnin@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU
Clermont-Ferrand, France
Contact: Martine BONNIN         
CHU
Grenoble, France
Contact: Anna Maria SANCHEZ-ROGE         
Hôpital Emile Roux
Le Puy-en-Velay, France
Contact: Aurélie COURBON         
CHU
Lille, France
Contact: Max GONZALEZ         
HCL
Lyon, France
Contact: Lionel BOUVET         
CHU
Nancy, France
Contact: Florence VIAL         
CHU
Nîmes, France
Contact: Estelle MORAU         
APHP Cochin
Paris, France
Contact: Catherine FISHER         
APHP Necker
Paris, France
Contact: Claudine KUMBA         
APHP Trousseau
Paris, France
Contact: Marie-Pierre BONNET         
Hôpital Jacques Puel
Rodez, France
Contact: Sophie DUFRAISSE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04719819    
Other Study ID Numbers: RNI 2020 BONNIN
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Anaesthesia, Spinal
Caesarean Section
Hyperbaric bupivacaine
Hemodynamic management after spinal anaesthesia
Maternal experience
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs