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Point of Care Ultrasound in Obstetric Triage

Handheld Point of Care Ultrasound in Obstetric Triage: A Cluster Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05938790
Acronym
POCUS
Enrollment
0
Registered
2023-07-10
Start date
2023-10-26
Completion date
2025-03-19
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Monitoring, Ultrasound

Keywords

fetal monitoring, obstetric triage, point of care ultrasound, antenatal monitoring

Brief summary

The research will find out if using portable ultrasound devices by nurses can make it quicker to get babies from 24 to 32 weeks on the doppler monitor.

Detailed description

In an acute obstetric unit such as labor and delivery triage, rapid determination of fetal status is crucial for optimal fetal outcomes. In most units, nursing staff holds the initial role of patient care for both mother and fetus. The expeditious and efficient application of external fetal monitoring (cEFM) acts as the cornerstone of fetal assessment in triage; however, factors such as early gestational age or maternal habitus may make an assessment with doppler alone challenging. The limited availability of physicians to assess with large, mobile bedside ultrasound units in these cases results in delays in care and decreases efficiency on the unit. Advanced ultrasound technology allows for the ready availability of point-of-care ultrasound devices using probes that connect to portable electronics through applications. Studies performed in low-resource and remote areas have demonstrated the utility of training nursing staff to perform point-of-care ultrasound (PoCUS); however, the literature needs to include studies performed at major academic centers. The study aims are to determine if the utilization of handheld PUM by nursing staff, as an ancillary tool to assist with applying cEFM in early preterm pregnancies, leads to decreased delays in the successful application of cEFM. The Butterfly Portable Ultrasound Device will be used for this study, which is a PUM that is lightweight, ultraportable and generates quality images equal to or better than the current larger SonoSite devices available. Secondary outcomes will examine the need for physician exams with bedside portable SonoSite ultrasound to apply cEFM as well as time to bedside once a physician is called for evaluation with bedside SonoSite.

Interventions

OTHERContinuous Fetal Monitoring

Fetal doppler used to monitor fetal heart rate in triage

OTHERPoint of Care Handheld Ultrasound

Point of Care Handheld Ultrasound

Sponsors

The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Patients will be included in the study if they meet the following criteria: * Women maternal age 18 to age 50 * Gestational age between 24 weeks 0 days and 32 weeks 0 days * Singleton pregnancy.

Exclusion criteria

Patients will be excluded if: * They are incarcerated * Outside the gestational window for inclusion * Are below the age of 18 * If the fetus has a known lethal anomaly and a decision has been made by the patient to decline fetal monitoring.

Design outcomes

Primary

MeasureTime frameDescription
Time to signal of fetal heart rateFrom date of randomization until the date of first successful detection of fetal heart rate up to 100 daysHow long does it take for the external fetal monitor to pick up a continuous fetal heart rate signal. From time fetal monitor is turned on to the successful detection of fetal heart rate, recorded in minutes and seconds up to 100 days.

Secondary

MeasureTime frameDescription
Physician paged to bedsideFrom date of randomization until the date of first successful detection of fetal heart rate up to 100 daysTime to bedside from when a physician is called for assessment. For each occurrence a physician is called to bedside, from time physician is contacted to time physician arrives at bedside recorded in minutes and seconds up to 100 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026