Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section (NCT04245891) | Clinical Trial Compass
CompletedNot Applicable
Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section
France265 participantsStarted 2016-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age \> 18
* Spinal Anesthesia for Cesarean Section
Exclusion Criteria:
* sub epidural cesarean section
* contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at using norepinephrine during spinal anesthesia for C-sections and measured lactate levels in newborns — can you explain what elevated lactate in a newborn would mean for my baby's health, and whether this is something I should be concerned about in my own delivery plan?
2Since this trial is already completed, would you be able to share or look up what the results showed about norepinephrine's effect on newborn lactate levels, and whether those findings might influence how my C-section anesthesia would be managed?
3I noticed this trial also listed stillbirth as one of the conditions being studied — can you help me understand whether that means my pregnancy has risk factors that make this kind of research relevant to me, and what that means for my care?
4Spinal anesthesia can cause a drop in blood pressure during a C-section, and this trial was testing norepinephrine as a way to manage that — is norepinephrine something my anesthesia team would consider using, and how does it compare to other medications they might use instead?
5Since this was listed as a Phase NA trial, meaning it may have been more of an observational or feasibility study, how much confidence can we have in any findings it produced, and are there larger studies I should ask about before making decisions about my anesthesia options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
lactate level
Timeframe: Just after the birth of the newborn baby