RecruitingNot ApplicableNCT06835647

Maternal Fetal Device Performance Twins

Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring

Sponsor

GE Healthcare

Enrollment

15 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

Pregnancy

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria4

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.

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Interventions

DEVICEInvestigational 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.

DEVICEUltrasound 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.