Clinical trial NCT05513066: Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension
Keywords: cesarean
spinal anesthesia
hypotension
norepinephrine
ephedrine
phenylephrine
sympathetic block
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: duration of the procedure up to one hour
Secondary outcomes:
measure: Clinical sign of hypotension
timeFrame: duration of the procedure up to one hour
measure: Foetal pH
timeFrame: at birth
measure: boli of vasopressor
timeFrame: duration of the procedure up to one hour
measure: boli of atropine
timeFrame: duration of the procedure up to one hour
measure: crystalloids
timeFrame: duration of the procedure up to one hour
measure: total diuresis
timeFrame: duration of the procedure up to one hour
measure: intrathecal local anesthetics
timeFrame: duration of the procedure up to one hour
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine BONNIN
role: STUDY_DIRECTOR
References:
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