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

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

Treatments tested in this trial

  • Investigational Fetal Monitor
  • Ultrasound Imaging Device

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators