Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section (NECS)

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.

Study Overview

• Status: Completed
• Conditions: Caesarean Section;Stillbirth

• Study Type: Observational
• Enrollment (Actual): 265

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women over 18 years of age who need a caesarean section

Description

Inclusion Criteria:

• age > 18
• Spinal Anesthesia for Cesarean Section

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group; boli of ephedrine phenylephrine (45μg/mL-3mg/mL) if the variation of MAP < 20% of baseline (MAP before spinal anaesthesia).
Protocol group; continuous infusion of norepinepineprhine at 20 μg/mL, started at 0.05 μg/kg/min. The dosage of norepinephrine was then adjusted to maintain a variation in MAP < 20% of baseline. In case of failure, the use of a control group boli injection was possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lactate level	The primary endpoint is the Umbilical Cord Lactate levels	Just after the birth of the newborn baby

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APGAR Score	APGAR Score	1, 5 and 10 minutes after birth
Umbilical Cord arterial PH	Umbilical Cord arterial PH	Just after the birth
Umbilical Cord venous PH	Umbilical Cord venous PH	Just after the birth
maternal arterial tension during cesarean section	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	incidences of mother nausea and vomiting	from beginning to cesarean section end
use of vasopressors	use of vasopressors	from beginning to cesarean section end

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth
• Other Study ID Numbers: IRB 17.11.01

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
• product manufactured in and exported from the U.S.: No