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Completed

NCT Number: NCT05906368

Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

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.

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Key information

Conditions

Anesthesia, Epidural Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ClearSight HPI Monitoring system

Diagnostic Test

Continuous blood pressure monitoring for precision hypotensive event response

Standard of Care Blood Pressure Monitoring

Diagnostic Test

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.

Primary outcomes

  1. 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

  2. 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."

  3. 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."

  4. 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."

Secondary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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.

Sponsors and collaborators

Lead sponsor

Grace Lim, MD, MS

Other

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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