Clinical trial NCT06726343: Maternal Fetal Device Performance Singleton
Official title: Maternal Fetal Device Performance Testing During Antepartum Singleton Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy
Singleton
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2024-12-10
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pregnant women of ≥22 weeks gestation will undergo two 30-minute monitoring sessions (60 minutes total). One with currently approved Corometrics 259cx and one with the investigational device. During both monitoring sessions, maternal pulse rate will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: This study aims to compare a maternal fetal monitoring device to the currently marketed Corometrics 259cx. Fetal heart rate and Fetal Movement Detection data will be collected during antenatal monitoring using standard of care Doppler Ultrasound transducers.

The new Maternal/Fetal Monitor is capable of monitoring heart rates (maternal/ fetal), maternal uterine contractions, as well as maternal blood pressure and maternal pulse oximetry. This study will compare clinical data between the current and the new monitor on non-laboring singleton gestation women.

Funding for this study will be provided by GE HealthCare. This study does not include patient advisors.

Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide written informed consent.
2. Singleton pregnancy.
3. Aged 18+.
4. Greater than or equal to 22 0/7 weeks gestation.
5. Patient has none of the exclusion criteria.

Exclusion Criteria:

1. Multiple 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.

Primary outcomes:
measure: FHR Success Rate
timeFrame: 60 minutes
Secondary outcomes:
measure: Collection of Raw Parameter Data
timeFrame: 30 minutes
measure: Collection of Automated Fetal Movement Detection and Remote Event Marks
timeFrame: 60 minutes
measure: Safety Analysis
timeFrame: 4 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Element Materials Technology
state: Colorado
Study officials:
affiliation: Element Materials Technology
name: Monica Rabanal, NP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Euliano TY, Darmanjian S, Nguyen MT, Busowski JD, Euliano N, Gregg AR. Monitoring Fetal Heart Rate during Labor: A Comparison of Three Methods. J Pregnancy. 2017;2017:8529816. doi: 10.1155/2017/8529816. Epub 2017 Mar 14.