Caesarean Section;StillbirthNECSNCT04245891
Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section
An observational study of Caesarean Section;Stillbirth, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Caesarean Section;Stillbirth
- Type of treatment
- Injection or infusion
- How many people
- 265 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2016to 30 Nov 2017
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: women over 18 years of age who need a caesarean section
Who may be able to join
- age > 18
- Spinal Anesthesia for Cesarean Section
Who cannot join
- sub epidural cesarean section
- contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Caesarean Section;Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
lactate level
The primary endpoint is the Umbilical Cord Lactate levels
Measured: Just after the birth of the newborn baby
Secondary outcomes (6)
APGAR Score
APGAR Score
Measured: 1, 5 and 10 minutes after birth
Umbilical Cord arterial PH
Umbilical Cord arterial PH
Measured: Just after the birth
Umbilical Cord venous PH
Umbilical Cord venous PH
Measured: Just after the birth
maternal arterial tension during cesarean section
maternal arterial tension during cesarean section
Measured: 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
Measured: from beginning to cesarean section end
use of vasopressors
use of vasopressors
Measured: from beginning to cesarean section end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 May 2016
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean Section;StillbirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245891
- Sponsor's protocol ID
- IRB 17.11.01
- Acronym
- NECS
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section
- ClinicalTrials.gov ID
- NCT04245891
- Acronym / sponsor ID
- NECS / IRB 17.11.01
- Conditions
- Caesarean Section;Stillbirth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 29 Jan 2020 (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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- women over 18 years of age who need a caesarean section
Key inclusion criteria (2 listed)
- age > 18
- Spinal Anesthesia for Cesarean Section
Key exclusion criteria (2 listed)
- sub epidural cesarean section
- contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lactate level
Time frame: Just after the birth of the newborn baby
The primary endpoint is the Umbilical Cord Lactate levels
6 secondary outcomes
APGAR Score
Time frame: 1, 5 and 10 minutes after birth
Umbilical Cord arterial PH
Time frame: Just after the birth
Umbilical Cord venous PH
Time frame: Just after the birth
maternal arterial tension during cesarean section
Time frame: 0, 5,10,15, 20 25, 30,35,40 minutes after spinal anesthesia
incidences of mother nausea and vomiting
Time frame: from beginning to cesarean section end
use of vasopressors
Time frame: from beginning to cesarean section end
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 18 Jun 2026.
- Individual participant dataSharing planned: No
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 Caesarean Section;Stillbirth, run by Centre Hospitalier Universitaire de Nīmes 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 18 Jun 2026. 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?
lactate level (time frame: Just after the birth of the newborn baby). 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 18 Jun 2026.