Neonatal Evaluation of Norepinephrine Infusion in Spinal... | NCT04245891

Studies
Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section

NCT04245891

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jun 18, 2026Actual

Enrollment

265Actual

Phase

Not provided

Conditions

Caesarean Section;Stillbirth

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2016Actual

Primary Completion Date

Nov 30, 2017Actual

Completion Date

Nov 30, 2017Actual

First Submitted Date

Jan 27, 2020

First Submission Date that Met QC Criteria

Jan 28, 2020

First Posted Date

Jan 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

265Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

women over 18 years of age who need a caesarean section

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nîmes		Nîmes	Gard	30029	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided