Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

October 10, 2025 updated by: Grace Lim, MD, MS

Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension -- Pilot Study

The purpose of this pilot trial is to examine the feasibility and ease of use of monitoring by ClearSight in laboring and delivering patients with the intent to compare time-to-treatment of hypotension between conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight, in a population of healthy laboring women who receive epidural analgesia.

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

In a prospective study, we will achieve the following aims:

To determine the feasibility and ease of use of the ClearSight monitoring system in the labor-delivery room (LDR) in detecting and monitoring hypotensive events post-epidural labor analgesia placement.

To compare the Time-to-Treatment of hypotensive events between the conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight.

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.
34

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Womens Hospital of UPMC

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant
  • Age ≥ 18 years of age
  • Planning vaginal delivery
  • Receiving epidural labor analgesia (ELA)

Exclusion Criteria:

  • Non-reassuring fetal tracing at the time of ELA request
  • Contraindications to ELA
  • Significant cardiac arrhythmias or aortic regurgitation
  • Arrhythmia
  • Treatment with antihypertensive medications
  • Pre-eclampsia with or without severe features
  • Preoperative infection
  • Inability to use ClearSight device for any reason
  • Non-English fluency
  • Sustains unintentional dural puncture
  • Incomplete data

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Sham Comparator: Conventional Care
Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.
Diagnostic test: Standard of Care Blood Pressure Monitoring
Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.
Experimental: ClearSight Monitoring
Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.
Diagnostic test: Standard of Care Blood Pressure Monitoring
Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.
Diagnostic test: ClearSight HPI Monitoring system
Continuous blood pressure monitoring for precision hypotensive event response

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
Time-to-treatment of Hypotension (Minutes)
Time Frame: From epidural placement until 4-hours post-infusion start
The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups
From epidural placement until 4-hours post-infusion start
Ease of Use by Clinical Staff
Time Frame: report at 4-hour post-infusion
Clinical nurse reports of ease of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems easy to use."
report at 4-hour post-infusion
Ease of Hypotension Detection by Clinical Staff
Time Frame: report at 4-hour post-infusion
Clinical nurse reports of ease of hypotension detection using ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems suitable."
report at 4-hour post-infusion
Satisfaction of ClearSight Use by Clinical Staff
Time Frame: report at 4-hour post-infusion
Clinical nurse reports of satisfaction of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device meets my approval."
report at 4-hour post-infusion

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
Nausea (Yes/No)
Time Frame: Epidural placement to 4-hours post-infusion start
Proportion of patients by group reporting nausea within 4-hours of post-epidural placement
Epidural placement to 4-hours post-infusion start
Vomiting (Yes/No)
Time Frame: Epidural placement to 4-hours post-infusion start
Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement
Epidural placement to 4-hours post-infusion start
Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)
Time Frame: Epidural placement to 4-hours post-infusion start
Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI).
Epidural placement to 4-hours post-infusion start
Total Phenylephrine, mg
Time Frame: Epidural placement to 4-hours post-infusion start
Average phenylephrine dose(s) given to patients in CM and CM+HPI groups
Epidural placement to 4-hours post-infusion start
Total Ephedrine, mg
Time Frame: Epidural placement to 4-hours post-infusion start
Average ephedrine dose(s) given to patients in CM and CM+HPI groups
Epidural placement to 4-hours post-infusion start
Total Intravenous Fluids, mL
Time Frame: Epidural placement to 4-hours post-infusion start
Average volume of fluids given to patients in CM and CM+HPI groups
Epidural placement to 4-hours post-infusion start
Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration)
Time Frame: Epidural placement to 4-hours post-infusion start
Total number of participants who experienced changes in fetal heart rate category (any)
Epidural placement to 4-hours post-infusion start
Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA
Time Frame: Epidural placement to 1-hour post-infusion start
Percentage of patients who experience any fetal heart rate deceleration event [Presence (Yes) or absence (No)] within 1-hour of epidural placement.
Epidural placement to 1-hour post-infusion start

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.
Grace Lim, MD, MS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Grace Lim, MD, MSc, University of Pittsburgh

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.
April 18, 2024

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.
August 29, 2024

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.
August 29, 2024

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).
May 8, 2023

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.
June 6, 2023

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.
June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
November 4, 2025

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.
October 10, 2025

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.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • STUDY23030009

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

Yes

product manufactured in and exported from the U.S.

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.

Clinical Trials on Hypotension

Clinical Trials on Standard of Care Blood Pressure Monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings