Maternal Fetal Device Performance Singleton
Completed · Not applicable
Conditions studied: Pregnancy
In brief
Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data to demonstrate the equivalent performance against the currently marketed Corometrics 259cx. The fetal heart rate and will be collected during antenatal monitoring using standard of care Doppler ultrasound.
Key facts
- Study ID
- NCT06726343
- Run by
- GE Healthcare
- People needed
- 30
- Starts
- 2024-10-28
- Expected to finish
- 2024-12-23
- Last updated by the study team
- 2026-01-07
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Able and willing to provide written informed consent.
- Singleton pregnancy.
- Aged 18+.
- Greater than or equal to 22 0/7 weeks gestation.
- Patient has none of the exclusion criteria.
You may not qualify if…
- Multiple 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.
Where it is running
- Element Materials Technology — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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