Maternal Fetal Device Performance Twins

NCT06835647 | Recruiting FDA Device

• 1 other identifier: SA-000073
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which support clinical decision making for pregnant women and assesses the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data by collecting simultaneous, continuous, external, distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the new maternal fetal monitoring investigational device and a marketed ultrasound imaging device.

Conditions

Pregnancy

Keywords

Pregnancy; Twins

Outcome Measures

Primary Outcomes (2)

• Collection of Distinct Fetal Heart Rate

  Collection of simultaneous, distinct fetal heart rate from SpO2 data from one investigational device over a 40 minutes of continuous fetal monitoring.

  40 minutes

• Collection of Maternal Pulse Rate

  Collection of maternal pulse rate from SpO2 data from one investigational device over a 40 minutes of continuous fetal monitoring.

  40 minutes

Secondary Outcomes (1)

• Incidence of Safety Events

  4 months

Study Arms (1)

Twin Monitoring - All Subjects

EXPERIMENTAL

Pregnant women of ≥30 0/7 weeks gestation will undergo one 40-minute monitoring session utilizing the investigational device with two Doppler transducers (FHR 1 and FHR 2) following M- mode fetal ultrasound imaging confirming fetal presentation, fetal lie, visualization of fetal heart rates of each fetus and documentation. During the monitoring sessions, maternal pulse rate (MPR) will be monitored using a SpO2 sensor and the investigator shall be present to adjust the transducers as needed to maintain a continuous FHR tracing.

Device: Investigational Fetal Monitor; Device: Ultrasound Imaging Device

Interventions

Investigational Fetal Monitor DEVICE

Investigational Fetal Monitoring Device Device is a multi-parameter maternal fetal monitor that is intended to monitor, store, display, transmit, and generate alarms for non-invasive and invasive clinical parameters of pregnant women and fetuses (singleton and twin), during the antepartum, intrapartum, and postpartum period.

Twin Monitoring - All Subjects

Ultrasound Imaging Device DEVICE

The Ultrasound imaging device is a general-purpose diagnostic ultrasound system for use in measurement, display and analysis of the human body and fluid.

Twin Monitoring - All Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent.
• Twin pregnancy.
• Aged 18+.
• Greater than or equal to 30 0/7 weeks gestation.

You may not qualify if:

• Non-twin pregnancy.
• Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
• Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.
• Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

RECRUITING

Related Publications (3)

• Ulrich CC, Dewald O. Pregnancy Ultrasound Evaluation(Archived). 2023 Feb 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557572/

  PMID: 32491504 BACKGROUND

• Euliano TY, Darmanjian S, Nguyen MT, Busowski JD, Euliano N, Gregg AR. Monitoring Fetal Heart Rate during Labor: A Comparison of Three Methods. J Pregnancy. 2017;2017:8529816. doi: 10.1155/2017/8529816. Epub 2017 Mar 14.

  PMID: 28392944 BACKGROUND

• Andelija S, Tafti D. Sonography Fetal Assessment, Protocols, and Interpretation. 2023 May 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK576427/

  PMID: 35015452 BACKGROUND

Study Officials

• Monica Rabanal, NP

  Element Materials Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amie Research Program Integrator

CONTACT

816-719-6765; Amie.Robinson@gehealthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pregnant women of ≥30 0/7 weeks gestation will undergo one 40-minute monitoring session utilizing the investigational device with two Doppler transducers (FHR 1 and FHR 2) following M- mode fetal ultrasound imaging confirming fetal presentation (i.e. vertex, breech, shoulder), fetal lie (i.e. longitudinal, transverse), visualization of fetal heart rates of each fetus and documentation. During the monitoring sessions, maternal pulse rate (MPR) will be monitored using a SpO2 sensor and the investigator shall be present to adjust the transducers as needed to maintain a continuous FHR tracing.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 19, 2025
• Study Start: January 21, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)