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NCT Number: NCT06835647

Maternal Fetal Device Performance Twins

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Element Materials Technology

Louisville, Colorado, 80027, United States

Location status: Recruiting

Location contact

Monica Rabanal, NP

CONTACT

[email protected]

303-926-5432

Monica Rabanal, NP

PRINCIPAL_INVESTIGATOR

About this study

This study aims to support a new maternal fetal monitoring device with clinical data by collecting distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the investigational device and a marketed ultrasound imaging device. This study will collect twin fetal heart rate data from the new monitor on twin gestations.

Funding for this study will be provided by GE HealthCare. This study does not include patient advisors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to provide written informed consent.
  • Twin pregnancy.
  • Aged 18+.
  • Greater than or equal to 30 0/7 weeks gestation.
  • Patient has none of the exclusion criteria.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Collection of Distinct Fetal Heart Rate

    Time frame: 40 minutes

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

  2. Collection of Maternal Pulse Rate

    Time frame: 40 minutes

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

Secondary outcomes

  1. Incidence of Safety Events

    Time frame: 4 months

    Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.

Study contacts

Contact information is provided by the study sponsor or research team.

Amie Research Program Integrator

CONTACT

[email protected]

816-719-6765

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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