Maternal Fetal Device Performance Twins

Last updated: February 17, 2025
Sponsor: GE Healthcare
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

Ultrasound Imaging Device

Investigational Fetal Monitor

Clinical Study ID

NCT06835647
SA-000073
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to provide written informed consent.

  2. Twin pregnancy.

  3. Aged 18+.

  4. Greater than or equal to 30 0/7 weeks gestation.

  5. Patient has none of the exclusion criteria.

Exclusion

Exclusion Criteria:

  1. Non-twin pregnancy.

  2. Involvement in another clinical trial currently or previously in this pregnancythat, in the investigator's opinion, would affect the conduct of this study.

  3. Medical or obstetric problem that in investigator's opinion would make the patientincapable of taking part in the study.

  4. Inability to understand the consent information due to medical illness, diminishedintellectual capacity, or insurmountable language barrier.

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Ultrasound Imaging Device
Phase:
Study Start date:
January 21, 2025
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Element Materials Technology

    Louisville, Colorado 80027
    United States

    Active - Recruiting

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