Health TrialsbyHealthPanel

Maternal Fetal Device Performance Twins

ConditionPregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGE Healthcare

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide written informed consent.

Twin pregnancy.

Aged 18+.

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Twin Monitoring - All SubjectsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
40 minutes
2

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.

Time frame
40 minutes

Secondary outcomes

1

Incidence of Safety Events

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.

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GE Healthcare

Lead sponsor

Source ClinicalTrials.gov
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