Anesthesia ComplicationNCT06264284
Emergency (Red Code) Cesarean Section : Maternal and Fetal Prognosis Depending on Anesthetic Modalities in a Level 3 Maternity Ward
An observational study of Anesthesia Complication, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Complication
- What is being tested?
- epidural anesthesia and general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2018to 19 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Pregnant women
- emergency "code red" cesarean section
Who cannot join
- Any other intervention
- Planned cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anesthesia Complication
- Being tested
- epidural anesthesia, general anesthesia
- Keywords
- c-section, cesarean section, epidural anesthesia, anesthesia complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural anesthesiaProcedure or surgery
Emergency cesarean section (red code) with epidural anesthesia
general anesthesiaProcedure or surgery
Emergency cesarean section (red code) with general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| epidural anesthesia | Not described Receives: Procedure: epidural anesthesia | |
| general anesthesia | Not described Receives: Procedure: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From July 19, 2018 to July 19, 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start19 Jul 2018
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, STANOWSKI Mattieu, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264284
- Sponsor's protocol ID
- 2023PI163
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency (Red Code) Cesarean Section : Maternal and Fetal Prognosis Depending on Anesthetic Modalities in a Level 3 Maternity Ward
- ClinicalTrials.gov ID
- NCT06264284
- Acronym / sponsor ID
- 2023PI163
- Conditions
- Anesthesia Complication
- Keywords
- c-section, cesarean section, epidural anesthesia, anesthesia complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural anesthesia | – | Procedure: epidural anesthesia |
| general anesthesia | – | Procedure: general anesthesia |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Pregnant women
- emergency "code red" cesarean section
Key exclusion criteria (2 listed)
- Any other intervention
- Planned cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural anesthesiaEmergency cesarean section (red code) with epidural anesthesia | Procedure or surgery | epidural anesthesia |
| general anesthesiaEmergency cesarean section (red code) with general anesthesia | Procedure or surgery | general anesthesia |
Primary outcome
To evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome
Time frame: From July 19, 2018 to July 19, 2023.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Complication, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome (time frame: From July 19, 2018 to July 19, 2023.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.