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Clinical Trials/NCT04245891
NCT04245891
Completed
N/A

Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section

Centre Hospitalier Universitaire de Nīmes0 sites265 target enrollmentMay 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Caesarean Section;Stillbirth
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
265
Primary Endpoint
lactate level
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This retrospective study aims to evaluate the fate of children born by cesarean section under spinal anesthesia with or without norepinephrine as vasopressor support for anesthesia. The main objective is to compare the initial Apgar score. The records of patients who received norepinephrine are compared to those without norepinephrine. To limit the biases of this type of study, the investigators will apply a propensity score that will include as a variable: age, ASA score, comorbidity, urgency. The patients analysed correspond to the period 2016-2017.

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
November 30, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age \> 18
  • Spinal Anesthesia for Cesarean Section

Exclusion Criteria

  • sub epidural cesarean section
  • contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)

Outcomes

Primary Outcomes

lactate level

Time Frame: Just after the birth of the newborn baby

The primary endpoint is the Umbilical Cord Lactate levels

Secondary Outcomes

  • Umbilical Cord venous PH(Just after the birth)
  • maternal arterial tension during cesarean section(0, 5,10,15, 20 25, 30,35,40 minutes after spinal anesthesia)
  • incidences of mother nausea and vomiting(from beginning to cesarean section end)
  • use of vasopressors(from beginning to cesarean section end)
  • APGAR Score(1, 5 and 10 minutes after birth)
  • Umbilical Cord arterial PH(Just after the birth)

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