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Clinical Trials/EUCTR2018-003182-34-FR
EUCTR2018-003182-34-FR
Active, not recruiting
Phase 1

Randomized, double-blind, controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion for maintenance of hemodynamic stability during cesarean section under spinal anesthesia - PHENAD

CHR d'ORLEANS0 sites124 target enrollmentAugust 30, 2018

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
CHR d'ORLEANS
Enrollment
124
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 30, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
CHR d'ORLEANS

Eligibility Criteria

Inclusion Criteria

  • \-Pregnancy \> 36 weeks of amenorrhea
  • \-Scheduled or semi\-urgent (interval between decision and delivery by caesarean section \>12hours) caesarean section under spinal anesthesia
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 124
  • F.1\.3 Elderly (\>\=65 years) no
  • F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • \-Extreme size (\<140cm,\> 180cm)
  • \-Weight less than 50kg
  • \- body mass index (BMI) \>40 kg/m2
  • \-Cardiovascular disease with use of cardiac medication
  • \-Active neurological disease.
  • \-antihypertensive drug.
  • \-severe pre\-eclampsia
  • \-American Society of Anesthesiologists physical status class \>3
  • \-Placenta accreta / percreta
  • \-Cesarean section scheduled under general anesthesia.

Outcomes

Primary Outcomes

Not specified

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