N/A
N=30
Maternal Fetal Device Performance Singleton
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT06726343 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group — 85.01; 92.27; 98.43 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fetal Monitoring Device (Device); Investigational Fetal Monitoring Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GE Healthcare
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group |
85.01; 92.27; 98.43 | — |
| PRIMARY Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group |
83.77; 89.07; 92.62 | — |
| PRIMARY Difference in Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational and Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group |
1.23; 3.20; 5.82 | — |
| SECONDARY Number of Raw Datasets of the Presence of Fetal Heart Rate During Continuous Monitoring Data From Investigational Device |
10; 10; 10 | — |
| SECONDARY Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Investigational Device |
10; 10; 10 | — |
| SECONDARY Number of Adverse Safety Events With Investigational Device |
0; 0; 0 | — |
| SECONDARY Number of Adverse Safety Events With Coro259 cx, FDA Approved Device |
0; 0; 0 | — |
| SECONDARY The Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Coro 259cx Device |
10; 10; 10 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06726343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.