Clinical trial NCT05938790: Point of Care Ultrasound in Obstetric Triage
Official title: Handheld Point of Care Ultrasound in Obstetric Triage: A Cluster Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ultrasound
Fetal Monitoring
Keywords: fetal monitoring
obstetric triage
point of care ultrasound
antenatal monitoring
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to signal of fetal heart rate
timeFrame: From date of randomization until the date of first successful detection of fetal heart rate up to 100 days
Secondary outcomes:
measure: Physician paged to bedside
timeFrame: From date of randomization until the date of first successful detection of fetal heart rate up to 100 days
Other outcomes:
Locations:
Study officials:
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