CompletedNot Applicable

Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

United States34 participantsStarted 2024-04-18

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time-to-treatment of Hypotension (Minutes)

Timeframe: From epidural placement until 4-hours post-infusion start

Ease of Use by Clinical Staff

Timeframe: report at 4-hour post-infusion

Ease of Hypotension Detection by Clinical Staff

Timeframe: report at 4-hour post-infusion

Satisfaction of ClearSight Use by Clinical Staff

Timeframe: report at 4-hour post-infusion

Trial details

NCT IDNCT05906368

SponsorGrace Lim, MD, MS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-29

Results submitted2025-08-28

View on ClinicalTrials.gov More Anesthesia, Epidural trials