NCT04245891

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

January 27, 2020

Last Update Submit

January 28, 2020

Conditions

Caesarean Section;Stillbirth

Outcome Measures

Primary Outcomes (1)

  • lactate level

    The primary endpoint is the Umbilical Cord Lactate levels

    Just after the birth of the newborn baby

Secondary Outcomes (6)

  • APGAR Score

    1, 5 and 10 minutes after birth

  • Umbilical Cord arterial PH

    Just after the birth

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women over 18 years of age who need a caesarean section

You may qualify if:

  • age \> 18
  • Spinal Anesthesia for Cesarean Section

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 29, 2020

Study Start

May 1, 2016

Primary Completion

November 30, 2017

Study Completion

November 30, 2017

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share