CompletedNot Applicable

Ephedrine Versus Phenylephrine for Spinal Block - Related Hypotension in Cesarean Delivery

Poland94 participantsStarted 2024-12-16

Plain-language summary

The study is designed to compare two strategies used in the management of hypotension caused by spinal anesthesia for cesarean section: intravenous phenylephrine given as prophylactic infusion and interventional boluses of intravenous ephedrine. Phenylephrine is currently recommended for battling spinal anesthesia - related sympathectomy, due to some scientific data on possible negative effects of ephedrine on fetal wellbeing. Therefore this study will retrospectively compare both clinical and laboratory data of the newborns delivered by cesarean section where either large dose of ephedrine or continuous infusion of phenylephrine was used for management of hypotension

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: * Cesarean delivery at term under spinal anesthesia * American Society of Anesthesiologists (ASA) physical status \<3 * BMI \<40 * Preemptive phenylephrine infusion or ephedrine boluses used during surgical procedure Exclusion Criteria: * No vasoconstrictor (phenylephrine nor ephedrine) used throughout the procedure * Total dose of ephedrine less than 15mg * poor quality of anesthetic record - data required for analysis not available

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

Umbilical blood pH

Timeframe: During delivery (from spinal injection to umbilical clamping and cutting)

Umbilical blood Base Excess (BE)

Timeframe: During delivery (from spinal injection to umbilical clamping and cutting)

Trial details

NCT IDNCT06741410

SponsorCentre of Postgraduate Medical Education

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-16

View on ClinicalTrials.gov More Spinal Anesthesia trials