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Maternal Fetal Device Performance Twins

NCT06835647 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-07-15

No results posted yet for this study

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

Interventions

DEVICE

Investigational Fetal Monitor

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.

DEVICE

Ultrasound Imaging 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.

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Monica Rabanal, NP · Element Materials Technology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2025-09-30
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06835647 on ClinicalTrials.gov