Pilot Study of Real-Time Blood Pressure Decision Support During Cesarean Delivery Under Spinal An… (NCT07534774) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study of Real-Time Blood Pressure Decision Support During Cesarean Delivery Under Spinal Anesthesia
United States20 participantsStarted 2025-06-16
Plain-language summary
This single-center, open-label pilot study evaluates a clinician-facing decision-support algorithm that displays real-time forecasts of maternal mean arterial pressure (MAP), a measure of blood pressure, during elective cesarean delivery under spinal anesthesia. The display provides 1-, 2-, and 3-minute MAP forecasts from the time of spinal anesthesia administration until delivery or up to 20 minutes, whichever occurs first. Clinicians continue to manage blood pressure according to usual institutional practice, including phenylephrine infusion and bolus dosing, and retain full autonomy over treatment decisions; the study display does not provide dosing recommendations. The primary objective is to assess the prospective accuracy of short-horizon MAP forecasts. Secondary outcomes assess intraoperative hypotension burden and phenylephrine exposure during the observation window, including exploratory comparison with matched nonconcurrent controls.
Who can participate
Age range
18 Years – 45 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
. Adult pregnant individuals (≥18 years old) presenting for elective or scheduled cesarean delivery.
. ASA physical status 2 or 3 (obstetric patients without severe comorbidities).
. Singleton pregnancy at term (≥37 weeks gestation).
. Planned spinal anesthesia for cesarean delivery with phenylephrine infusion (and/or boluses) as the primary vasopressor.
. Able to provide informed consent.
. No known fetal anomalies or intrauterine demise.
Exclusion criteria
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
1
Root Mean Square Error of 1-Minute-Ahead Mean Arterial Pressure Forecast
Timeframe: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
2
Root Mean Square Error of 2-Minute-Ahead Mean Arterial Pressure Forecast
Timeframe: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
3
Root Mean Square Error of 3-Minute-Ahead Mean Arterial Pressure Forecast
Timeframe: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
. Pre-existing or gestational hypertensive disorders (e.g., chronic hypertension, preeclampsia, eclampsia) or use of cardiovascular medications that can affect blood pressure or heart rate (e.g.
. Known major cardiovascular disease or arrhythmias requiring treatment (e.g., heart failure, significant valvular disease).
. Planned use of non-phenylephrine vasopressors (e.g., ephedrine, norepinephrine) for routine BP management.
. Allergy or contraindication to bupivacaine or phenylephrine.
. Urgent or emergent cesarean delivery (where time constraints may not allow for adequate data collection or informed consent).
. Inability to cooperate with protocol procedures.