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Portable Ultrasound Monitoring for Premature Infant Monitoring (POCUS Trial)

N/A

Recruiting

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of first successful detection of fetal heart rate up to 100 days

Awards & highlights

POCUS Trial Summary

This trial will test if nurses using portable ultrasound can help speed up monitoring of premature babies.

Who is the study for?

This trial is for pregnant women aged 18 to 50 with a single baby between 24 and 32 weeks of gestation. It's not suitable for those outside this pregnancy window, under age 18, if the fetus has a known lethal anomaly where monitoring was declined, or if they are incarcerated.Check my eligibility

What is being tested?

The study is examining whether nurses using handheld ultrasound devices can speed up the process of fetal monitoring on babies from ages of gestational weeks 24 to 32 compared to standard procedures.See study design

What are the potential side effects?

Since this trial involves non-invasive ultrasound monitoring, there are typically no direct side effects associated with its use in obstetric care.

POCUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of first successful detection of fetal heart rate up to 100 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of first successful detection of fetal heart rate up to 100 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of first successful detection of fetal heart rate up to 100 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Time to signal of fetal heart rate

Secondary outcome measures

Physician paged to bedside

POCUS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Point of Care Handheld UltrasoundExperimental Treatment1 Intervention

A nurse will turn on the Obix cEFM machine which will automatically register the patient in the Obix system and begin the timer which will be used to measure time to fetal monitoring. The patient will lay on the triage stretcher and a Butterfly ultrasound (Figure 1) probe will be used with a secure institutional Ipad by the triage nurse to identify the fetal position and location of the fetal heart. All images are deidentified and not stored since it will be a live real time aid to obtain a fetal heart tracing via cEFM. The cEFM will be placed on the maternal abdomen according to the imaging obtained by the ultrasound. Once fetal heart rate signal is obtained via cEFM, the patient's participation in the study ends.

Group II: Continuous Fetal MonitoringActive Control1 Intervention

A nurse will turn on the Obix cEFM machine which will automatically register the patient in the Obix system and begin the timer which will be used to measure time to fetal monitoring. The patient will lay on the triage stretcher and the continuous external fetal monitor doppler probe will be placed on the abdomen over the fetus, identified via Leopold maneuvers. Nurses will adjust the cEFM as needed until a full fetal heart rate signal is obtained. At this point the timer will be counted as the time to monitor. Once the fetal heart rate signal is obtained via cEFM, the patient's participation in the study ends.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor

243 Previous Clinical Trials

56,311 Total Patients Enrolled

Media Library

Point of Care Handheld Ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT05938790 — N/A

Ultrasound Research Study Groups: Continuous Fetal Monitoring, Point of Care Handheld Ultrasound

Ultrasound Clinical Trial 2023: Point of Care Handheld Ultrasound Highlights & Side Effects. Trial Name: NCT05938790 — N/A

Point of Care Handheld Ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT05938790 — N/A

Frequently Asked Questions

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

Does this research project permit persons over 55 to participate?

"This clinical trial adheres to a strict age limit policy, wherein participants must be between 18 and 50 years old."

Answered by AI

Is recruitment still taking place for this research project?

"The clinical trial info posted to clinicaltrials.gov confirms that this medical study, which was initially listed on September 1st 2023, is not currently recruiting patients. However, there are 12 other studies actively seeking enrolment at the present time."

Answered by AI

Is it possible for me to partake in this research?

"The trial is open to participants between 18 and 50 years old, who have undergone ultrasound imaging. This nationwide study expects to enlist 360 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Point of Care Ultrasound in Obstetric Triage

2023. "Point of Care Ultrasound in Obstetric Triage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05938790.