TerminatedPhase 4

Norepinephrine in Caesarian Section

Stopped: patient inclusion is too difficult

Belgium11 participantsStarted 2022-06-09

Plain-language summary

Postspinal hypotension is a frequent maternal complication in caesarian delivery under neuraxial anesthesia which is most commonly treated with the administration of phenylephrine infusion. In this trial, postspinal hypotension will be treated with norepinephrine. The main objective is to examine the pharmacodynamic and biochemical effect of norepinephrine both on mother and newborn.

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: * American Society of Anesthesiologists classification (ASA)1 and 2 patients * non-laboring and singleton pregnancy Exclusion Criteria: * patients with cardiovascular comorbidities * any kind of cardiac and peripheral vascular disease or diabetes * history of coagulopathy * contra-indication to spinal anesthesia * allergic condition to vasopressors or local anesthetics * total body weight under 50kg or above 100kg * length under 150cm and over 180cm Body Mass Index (BM)I ≥ 32

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

dose norepinephrine used in group A

Timeframe: from administration of spinal anesthesia until delivery of the newborn

dose norepinephrine used in group B

Timeframe: from administration of spinal anesthesia until delivery of the newborn

Trial details

NCT IDNCT05264870

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-02

View on ClinicalTrials.gov More Cesarean Section Complications trials