Pilot Study of Real-Time Blood Pressure Decision Support During Cesarean Delivery Under Spinal Anesthesia

NCT07534774 | Completed

• 1 other identifier: 2025P000588
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Hypotension

Keywords

cesarean delivery; phenylephrine; autoregressive with exogenous input; decision support

Outcome Measures

Primary Outcomes (3)

• Root Mean Square Error of 1-Minute-Ahead Mean Arterial Pressure Forecast

  Patient-level mean root mean square error (RMSE) between algorithm-predicted and observed maternal mean arterial pressure (MAP) for the 1-minute forecast horizon using minute-level intraoperative data.

  From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.

• Root Mean Square Error of 2-Minute-Ahead Mean Arterial Pressure Forecast

  Patient-level mean root mean square error (RMSE) between algorithm-predicted and observed maternal mean arterial pressure (MAP) for the 2-minute forecast horizon using minute-level intraoperative data.

  From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.

• Root Mean Square Error of 3-Minute-Ahead Mean Arterial Pressure Forecast

  Patient-level mean root mean square error (RMSE) between algorithm-predicted and observed maternal mean arterial pressure (MAP) for the 3-minute forecast horizon using minute-level intraoperative data.

  From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.

Secondary Outcomes (3)

• Incidence of Maternal Hypotension During the Observation Window

  From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.

• Duration of Maternal Hypotension During the Observation Window

  From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.

• Total Phenylephrine Dose During the Observation Window

  From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.

Study Arms (1)

ARX Decision-Support Display

EXPERIMENTAL

Participants undergoing elective cesarean delivery under spinal anesthesia received standard clinical management plus a clinician-facing ARX decision-support display that showed 1-, 2-, and 3-minute forecasts of maternal mean arterial pressure from spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first. The display did not provide dosing recommendations. Phenylephrine infusion and bolus dosing remained under clinician direction according to institutional practice.

Other: ARX Decision-Support Display

Interventions

ARX Decision-Support Display OTHER

A clinician-facing decision-support display that presented real-time 1-, 2-, and 3-minute forecasts of maternal mean arterial pressure during elective cesarean delivery under spinal anesthesia, from spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first. The display did not provide dosing recommendations. Phenylephrine infusion and bolus dosing remained under clinician direction according to institutional practice

ARX Decision-Support Display

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• propranolol for migraine)
• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: June 16, 2025
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)