Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline (ARTEMIS)

October 11, 2022 updated by: University Hospital, Clermont-Ferrand

Prospective, Observational and Bicentric Study of the Management of Arterial Hypotension During Planned Caesarean Section. Practice Comparison Between a Referral Center Using According to Service Protocol, an Intravenous Ephedrine/Phenylephrine Mixture at the PSE Versus Another Referral Center Using According to Service Protocol Intravenous Baby Noradrenaline

Comparison of two practices of obstetrical services between the CHU of Clermont Ferrand and the HFME Lyon-Bron in the management of arterial hypotension during an elective cesarean section

Study Overview

Status

Recruiting

Conditions

Detailed Description

The investigators propose to carry out a bicentric strict observational prospective study between the maternity of the HFME of Lyon-Bron which uses the mixture ephedrine / noradrenaline with the PSE for many years in service protocol for the management of hypotension for cesarean section under perimedullary anesthesia and the CHU of Clermont-Ferrand which uses baby noradrenaline 10 mcg/mL PSE for this same indication according to an institutional protocol. Patients corresponding to the inclusion and non-inclusion criteria will be recruited by a physician investigator and will give their agreement of non-opposition after having received clear oral and written information about our study. The care will not be modified in any way compared to the usual practices of the service.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Recruiting
        • Chu Clermont-Ferrand
        • Principal Investigator:
          • Martine BONNIN
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon
        • Principal Investigator:
          • Lionel BOUVET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients are included on their entry in the obstetrical operating room during an elective caesarean section if they meet the inclusion and exclusion criteria. The investigating doctor informs them of the terms of our purely observational research study before the intervention and asks them for their oral agreement.

The study treatment administered depends on the protocol of the center in which they are included.

Description

Inclusion Criteria:

  • elective caesarean
  • ≥ 18 years old
  • term ≥ 36 weeks amenorrhea

Exclusion Criteria:

  • contraindication of local anesthetics
  • contraindication of spinal anesthesia
  • patient's refusal
  • patient doesn't talk French
  • patient not covered by the social security system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ephedrine/phenylephrine mixture
10 mL of 0.75 mg/ml ephedrine and 10 mL of 37.5 μg/ml phenylephrine are mixed in a 20 mL syringe. The speed is generally started at 20 ml/h and then adapted according to blood pressure.
baby noradrenaline
20 mL of baby norepinephrine 10µg/mL is prepared in a 50 mL syringe. The speed is generally started at 30 ml/h and then adapted according to blood pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: duration of the procedure up to one hour
Time-weighted mean intraoperative systolic blood pressure below a threshold of 80mmHg, 90mmHg and 100mmHg. This measurement is commonly called TWA (time weighted average), corresponding to the area between the chosen PAS threshold and the curve of the measured PAS, divided by the total time of the measurements. Blood pressure will be measured by the Clearsight system, absolutely non-invasive continuous pulse wave contour monitoring.
duration of the procedure up to one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical sign of hypotension
Time Frame: duration of the procedure up to one hour
nausea, vomiting, faint
duration of the procedure up to one hour
Foetal pH
Time Frame: at birth
arterial and venous
at birth
boli of vasopressor
Time Frame: duration of the procedure up to one hour
appeal to boli of ephedrine and/or phenylephrine and/or noradrenaline
duration of the procedure up to one hour
boli of atropine
Time Frame: duration of the procedure up to one hour
appeal to boli of atropine
duration of the procedure up to one hour
crystalloids
Time Frame: duration of the procedure up to one hour
volume of crystalloids infused
duration of the procedure up to one hour
total diuresis
Time Frame: duration of the procedure up to one hour
duration of the procedure up to one hour
intrathecal local anesthetics
Time Frame: duration of the procedure up to one hour
amount of intrathecal local anesthetics injected
duration of the procedure up to one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Study Director: Martine BONNIN, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 2, 2022

Primary Completion (ANTICIPATED)

February 1, 2024

Study Completion (ANTICIPATED)

February 1, 2024

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (ACTUAL)

August 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022 BONNIN ARTEMIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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