N/A N=34 Randomized Single-blind Diagnostic

Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Anesthesia, Epidural · Hypotension

Bottom Line

View on ClinicalTrials.gov: NCT05906368 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Time-to-treatment of Hypotension (Minutes) — 21.8; 23.1 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ClearSight HPI Monitoring system (Diagnostic_test); Standard of Care Blood Pressure Monitoring (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Grace Lim, MD, MS
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Time-to-treatment of Hypotension (Minutes)	21.8; 23.1	—
PRIMARY Ease of Use by Clinical Staff	1; 1; 4; 4; 6; 7	—
PRIMARY Ease of Hypotension Detection by Clinical Staff	1; 1; 4; 3; 0; 2	—
PRIMARY Satisfaction of ClearSight Use by Clinical Staff	1; 0; 5; 5; 7; 8	—
SECONDARY Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)	12.5; 7.7	—
SECONDARY Nausea (Yes/No)	5; 7; 9; 8	—
SECONDARY Vomiting (Yes/No)	3; 0; 11; 16	—
SECONDARY Total Phenylephrine, mg	223.3; 506.7	—
SECONDARY Total Ephedrine, mg	29.8; 23.3	—
SECONDARY Total Intravenous Fluids, mL	550.0; 535.7	—
SECONDARY Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration)	8; 6; 6; 9	—
SECONDARY Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA	5; 5; 9; 10	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05906368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.