Maternal Fetal Device Performance Twins

Description

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.

Conditions

Pregnancy

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Study Overview

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Study Details

Study overview

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.

Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring

Maternal Fetal Device Performance Twins

Condition
Pregnancy
Intervention / Treatment

-

Contacts and Locations

Louisville

Element Materials Technology, Louisville, Colorado, United States, 80027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 1. Non-twin pregnancy.
  • 2. Involvement in another clinical trial currently or previously in this pregnancy that, 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 patient incapable of taking part in the study.
  • 4. Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

GE Healthcare,

Monica Rabanal, NP, PRINCIPAL_INVESTIGATOR, Element Materials Technology

Study Record Dates

2025-12-31