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 range18 Years

SexFEMALE

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

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