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

April 10, 2026 updated by: Vesela Kovacheva, MD, Brigham and Women's Hospital

Open-Label Pilot Study of a Clinician-Facing Decision-Support Algorithm for Blood Pressure Forecasting During Cesarean Delivery Under Spinal Anesthesia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This single-center, open-label, single-group pilot study evaluated the prospective performance and operating-room feasibility of a clinician-facing autoregressive with exogenous input (ARX) decision-support algorithm for short-horizon maternal blood pressure forecasting during elective cesarean delivery under spinal anesthesia. Adult pregnant patients at term undergoing elective cesarean delivery with planned spinal anesthesia and prophylactic phenylephrine management were enrolled at a tertiary care academic hospital.

The ARX system generated real-time forecasts of maternal mean arterial pressure (MAP) at 1-, 2-, and 3-minute horizons from the time of spinal anesthesia administration until delivery or 20 minutes, whichever occurred first. The model used prior MAP values together with time-stamped phenylephrine infusion and bolus dosing and intrathecal bupivacaine dose/time as inputs. Forecasts were displayed on a dedicated screen adjacent to the anesthesia workstation. The display was intended to support clinician awareness of short-horizon hemodynamic trends and did not provide dosing recommendations. Blood pressure management remained under usual clinical care, including phenylephrine infusion and bolus administration according to institutional practice, and treating anesthesiologists retained full autonomy over all management decisions.

The primary objective was to assess prospective forecast accuracy at each prediction horizon using the difference between predicted and observed MAP during the study observation window. Additional analyses assessed other forecast-accuracy metrics, short-horizon identification of hypotension defined as MAP below 80% of baseline, and implementation feasibility based on uninterrupted display operation and clinician-reported overrides. Baseline MAP was defined as the mean of the last three pre-spinal noninvasive blood pressure measurements. Baseline MAP was defined as the mean of the last three pre-spinal noninvasive blood pressure measurements. Noninvasive blood pressure was recorded at 1-minute intervals, and model inputs were entered in real time by in-room research staff. Secondary outcomes assessed intraoperative hypotension burden and phenylephrine exposure during the observation window, including exploratory comparison with matched nonconcurrent controls; these analyses were not part of prospective assignment to the study intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult pregnant individuals (≥18 years old) presenting for elective or scheduled cesarean delivery.
  2. ASA physical status 2 or 3 (obstetric patients without severe comorbidities).
  3. Singleton pregnancy at term (≥37 weeks gestation).
  4. Planned spinal anesthesia for cesarean delivery with phenylephrine infusion (and/or boluses) as the primary vasopressor.
  5. Able to provide informed consent.
  6. No known fetal anomalies or intrauterine demise.

Exclusion Criteria:

  1. 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)

  2. Known major cardiovascular disease or arrhythmias requiring treatment (e.g., heart failure, significant valvular disease).
  3. Planned use of non-phenylephrine vasopressors (e.g., ephedrine, norepinephrine) for routine BP management.
  4. Allergy or contraindication to bupivacaine or phenylephrine.
  5. Urgent or emergent cesarean delivery (where time constraints may not allow for adequate data collection or informed consent).
  6. Inability to cooperate with protocol procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARX Decision-Support Display
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Root Mean Square Error of 1-Minute-Ahead Mean Arterial Pressure Forecast
Time Frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
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
Time Frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
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
Time Frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Maternal Hypotension During the Observation Window
Time Frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Presence of at least one maternal mean arterial pressure measurement below 80% of baseline during the observation window; exploratory comparison with matched nonconcurrent controls.
From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Duration of Maternal Hypotension During the Observation Window
Time Frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Cumulative minutes with maternal mean arterial pressure below 80% of baseline during the observation window; exploratory comparison with matched nonconcurrent controls.
From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Total Phenylephrine Dose During the Observation Window
Time Frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Total phenylephrine dose calculated as the sum of all bolus doses plus infusion dose integrated over time during the observation window; exploratory comparison with matched nonconcurrent controls.
From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025P000588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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