Recruiting

Maternal Fetal Monitoring

Sponsor:

GE Healthcare

Code:

NCT06835647

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Investigational Fetal Monitor

Ultrasound Imaging Device

Study Details

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.

Conditions

Pregnancy

Study ID

NCT06835647

Start date

Jan 21, 2025

Status verified date

Jul, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Twin Monitoring - All Subjects

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, fetal lie, 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.

Interventions

Investigational Fetal Monitor

Investigational Fetal Monitoring Device Device is a multi-parameter maternal fetal monitor that is intended to monitor, store, display, transmit, and generate alarms for non-invasive and invasive clinical parameters of pregnant women and fetuses (singleton and twin), during the antepartum, intrapartum, and postpartum period.

Ultrasound Imaging Device

The Ultrasound imaging device is a general-purpose diagnostic ultrasound system for use in measurement, display and analysis of the human body and fluid.

Primary outcome measure

  • Collection of Distinct Fetal Heart Rate [ Time Frame: 40 minutes ]
  • Collection of Maternal Pulse Rate [ Time Frame: 40 minutes ]

Central Contacts and Locations

Central contacts

Amie Research Program Integrator

816-719-6765Amie.Robinson@gehealthcare.com

Locations

Element Materials Technology

Recruiting

Louisville, Colorado, United States, 80027

Contacts

Monica Rabanal, NP

303-926-5432Monical.Rabanal@element.com

Principal Investigator:

Monica Rabanal, NP

More Information

Sponsor

GE Healthcare

Last update posted

Jul 15, 2025

Last verified

Jul, 2025

Keywords

  • Pregnancy
  • Twins

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by GE Healthcare on 2025-07-15.