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ClearSight Monitoring for Epidural-Induced Low Blood Pressure

N/A

Waitlist Available

Led By Grace Lim, MD, McS

Research Sponsored by Grace Lim, MD, MS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years of age

Receiving epidural labor analgesia (ELA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up report at 4-hour post-infusion

Awards & highlights

Study Summary

This trial aims to compare labor monitoring methods to see which gets hypotension treatment faster. Healthy women receiving epidurals will be monitored conventionally or with ClearSight.

Who is the study for?

This trial is for pregnant women aged 18 or older who are receiving epidural labor analgesia. It's not suitable for those with non-reassuring fetal health, contraindications to epidurals, serious heart issues like arrhythmias or aortic regurgitation, high blood pressure treatments, pre-eclampsia, infections before surgery, or if the ClearSight device can't be used on them.Check my eligibility

What is being tested?

The study is testing how well the ClearSight HPI Monitoring system works compared to standard blood pressure monitoring in managing low blood pressure during labor with an epidural. The goal is to see if this new system can detect and treat hypotension faster in healthy women giving birth.See study design

What are the potential side effects?

Since this trial focuses on monitoring methods rather than medications, there aren't direct side effects from interventions being tested. However, general risks associated with epidural analgesia may include low blood pressure which the study aims to monitor and manage effectively.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am receiving pain relief through an epidural during labor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ report at 4-hour post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~report at 4-hour post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and report at 4-hour post-infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ease of hypotension detection by clinical staff

Ease of use by clinical staff

Satisfaction of ClearSight use by clinical staff

+1 more

Secondary outcome measures

Fetal heart rate decelerations within 1 hour of initiation of ELA

Nausea (Yes/No)

Total ephedrine, mg

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ClearSight MonitoringExperimental Treatment2 Interventions

Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.

Group II: Conventional CarePlacebo Group1 Intervention

Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Grace Lim, MD, MSLead Sponsor

8 Previous Clinical Trials

583 Total Patients Enrolled

Edwards LifesciencesIndustry Sponsor

180 Previous Clinical Trials

61,544 Total Patients Enrolled

Grace Lim, MD, McSPrincipal InvestigatorUniversity of Pittsburgh Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this research endeavor?

"Edwards Lifesciences, the clinical trial sponsor, has outlined their main objective as assessing ease of use by medical staff from epidural placement to 4 hours after infusion commencement. Additionally, they will be evaluating secondary goals such as nausea/vomiting frequency within a four hour window and average phenylephrine doses given in both groups."

Answered by AI

Are there still opportunities to join this research initiative?

"As evidenced on clinicaltrials.gov, the trial posted June 15th 2023 is not currently recruiting patients and has been last updated 6/6/2023. However, there are still 126 other studies that need volunteers to participate in their medical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Grace Lim, MD, MS 2026. "Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05906368.