NCT06264284

Brief Summary

We try to evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome on emergency (Red Code) Cesarean Section. This study occurred in a Level 3 Maternity Ward.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 19, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

February 12, 2024

Last Update Submit

February 12, 2024

Conditions

Anesthesia Complication

Keywords

c-section, cesarean section, epidural anesthesia, anesthesia complication

Outcome Measures

Primary Outcomes (1)

  • To evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome

    Identify all pregnant women who received an emergency "code red" cesarean section Confront epidural anesthesia and general anesthesia on maternal complications (low blood pressure, anesthetic failure) and neonatal outcomes (Apgar scores, arterial pH at the umbilical cord, arterial lactate, need for tracheal intubation at birth, admission of the newborn to intensive care/intensive care, death)

    From July 19, 2018 to July 19, 2023.

Study Arms (2)

epidural anesthesia

Procedure: epidural anesthesia

general anesthesia

Procedure: general anesthesia

Interventions

epidural anesthesiaPROCEDURE

Emergency cesarean section (red code) with epidural anesthesia

epidural anesthesia
general anesthesiaPROCEDURE

Emergency cesarean section (red code) with general anesthesia

general anesthesia

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women who have undergone an emergency "code red" cesarean from July 19, 2018 to July 19, 2023, at the Nancy CHRU maternity ward

You may qualify if:

  • Pregnant women
  • emergency "code red" cesarean section

You may not qualify if:

  • Any other intervention
  • Planned cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanowski

Nancy, 54000, France

Location

MeSH Terms

Interventions

Anesthesia, EpiduralAnesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 16, 2024

Study Start

July 19, 2018

Primary Completion

July 19, 2023

Study Completion

July 19, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

FR(1)