Point of Care Ultrasound in Obstetric Triage

NCT05938790 | Withdrawn

• 1 other identifier: 22-0220
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ultrasound; Fetal Monitoring

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to signal of fetal heart rate

  How 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.

  From date of randomization until the date of first successful detection of fetal heart rate up to 100 days

Secondary Outcomes (1)

• Physician paged to bedside

  From date of randomization until the date of first successful detection of fetal heart rate up to 100 days

Study Arms (2)

Continuous Fetal Monitoring

ACTIVE COMPARATOR

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.

Other: Continuous Fetal Monitoring

Point of Care Handheld Ultrasound

EXPERIMENTAL

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.

Other: Point of Care Handheld Ultrasound

Interventions

Continuous Fetal Monitoring OTHER

Fetal doppler used to monitor fetal heart rate in triage

Continuous Fetal Monitoring

Point of Care Handheld Ultrasound OTHER

Point of Care Handheld Ultrasound

Point of Care Handheld Ultrasound

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients will be excluded if:
• They are incarcerated
• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 10, 2023
• Study Start: October 26, 2023
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share