Not Yet RecruitingNot Applicable

Minimum Effective Volume of Crystalloid Co-Loading to Prevent Spinal Anesthesia-Induced Hypotension in Cesarean Section

45 participantsStarted 2025-12-27

Plain-language summary

The goal of this clinical trial is to find the minimum effective volume of IV crystalloid that should be given with phenylephrine to prevent hypotension caused by spinal anesthesia in healthy, term pregnant adults having elective cesarean delivery. The main questions are: What is the minimum effective volume (MEV90, mL/kg) of crystalloid co-loading that prevents spinal-anesthesia-induced hypotension in ≥90% of participants? What maternal side effects and newborn outcomes occur with this strategy (e.g., nausea/vomiting, need for extra vasopressors, total fluids/blood loss, Apgar scores, and umbilical cord blood gases)? There is no separate comparison group; this is a single-arm, adaptive dose-finding study. Participants will: Receive a predefined volume of IV crystalloid over \~10 minutes during spinal anesthesia while phenylephrine is infused. Have blood pressure and symptoms monitored; receive rescue treatment if needed. Allow the next participant's fluid volume to be adjusted based on whether hypotension occurred (biased-coin design). Be followed through postoperative day 2 for maternal and newborn outcomes.

Who can participate

Age range

19 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: * Pregnant adults ≥19 years scheduled for elective cesarean delivery under spinal anesthesia * Term pregnancy (≥37 weeks' gestation) Exclusion Criteria: * Emergency cesarean delivery * Hypertensive disorders of pregnancy (preeclampsia/eclampsia) or hypertension * Multiple gestation * Body weight \<50 kg or BMI \>35 kg/m² * Renal impairment or eGFR ≤90 mL/min/1.73 m² * Heart failure or other heart disease * History of bronchial asthma or other pulmonary disease

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

Minimum Effective Volume (MEV90) of Intravenous Crystalloid Co-Loading (mL/kg)

Timeframe: From intrathecal injection (start of spinal anesthesia) to end of surgery

Trial details

NCT IDNCT07324512

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

View on ClinicalTrials.gov More Spinal Induced Hypotension in Cesarean Delivery trials