Clinical trial NCT06835647: Maternal Fetal Device Performance Twins
Official title: Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy
Twins
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pregnant women of ≥30 0/7 weeks gestation will undergo one 40-minute monitoring session utilizing the investigational device with two Doppler transducers (FHR 1 and FHR 2) following M- mode fetal ultrasound imaging confirming fetal presentation (i.e. vertex, breech, shoulder), fetal lie (i.e. longitudinal, transverse), visualization of fetal heart rates of each fetus and documentation. During the monitoring sessions, maternal pulse rate (MPR) will be monitored using a SpO2 sensor and the investigator shall be present to adjust the transducers as needed to maintain a continuous FHR tracing.
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 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.

Detailed description: This study aims to support a new maternal fetal monitoring device with clinical data by collecting distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the investigational device and a marketed ultrasound imaging device. This study will collect twin fetal heart rate data from the new monitor on twin gestations.

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. Twin pregnancy.
3. Aged 18+.
4. Greater than or equal to 30 0/7 weeks gestation.
5. Patient has none of the exclusion criteria.

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.

Primary outcomes:
measure: Collection of Distinct Fetal Heart Rate
timeFrame: 40 minutes
measure: Collection of Maternal Pulse Rate
timeFrame: 40 minutes
Secondary outcomes:
measure: Incidence of Safety Events
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: Ulrich CC, Dewald O. Pregnancy Ultrasound Evaluation(Archived). 2023 Feb 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557572/
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.
citation: Andelija S, Tafti D. Sonography Fetal Assessment, Protocols, and Interpretation. 2023 May 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK576427/