N/A
Completed N=34
Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension
Anesthesia, Epidural · Hypotension
Source: ClinicalTrials.gov NCT05906368 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Time-to-treatment of Hypotension (Minutes) — 21.8; 23.1 minutes
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.
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 | — |
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
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. Informational only — not medical advice.