Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Last updated: October 10, 2025
Sponsor: Grace Lim, MD, MS
Overall Status: Completed

Phase

N/A

Condition

Dizzy/fainting Spells

Vascular Diseases

Circulation Disorders

Treatment

ClearSight HPI Monitoring system

Standard of Care Blood Pressure Monitoring

Clinical Study ID

NCT05906368
STUDY23030009
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant

  • Age ≥ 18 years of age

  • Planning vaginal delivery

  • Receiving epidural labor analgesia (ELA)

Exclusion

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 Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: ClearSight HPI Monitoring system
Phase:
Study Start date:
April 18, 2024
Estimated Completion Date:
August 29, 2024

Study 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.

Connect with a study center

  • Magee Womens Hospital of UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Magee Womens Hospital of UPMC

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

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