Monitoring fetal health in twin pregnancies
Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring
This study tests a new device that monitors the heart rates of twins during pregnancy to see if it works better than the current ultrasound method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | GE Healthcare Industry-sponsored |
| Locations | 1 site (Louisville, Colorado) |
| Trial ID | NCT06835647 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new maternal fetal monitoring device designed to collect and analyze fetal heart rate data from twin pregnancies. Using ultrasound Doppler transducers, the study aims to gather simultaneous and continuous heart rate readings from both fetuses. The data collected will be compared with that from a marketed ultrasound imaging device to assess the performance of the investigational monitor. The goal is to enhance clinical decision-making and improve outcomes for mothers and their twins during pregnancy and delivery.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older who are at least 30 weeks gestation with a twin pregnancy.
Not a fit: Patients with non-twin pregnancies or those with significant medical or obstetric issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of twin pregnancies, enhancing fetal health outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in fetal monitoring, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Louisville, Colorado
- Element Materials Technology — Louisville, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Monica Rabanal, NP — Element Materials Technology
- Study coordinator: Amie Research Program Integrator
- Email: Amie.Robinson@gehealthcare.com
- Phone: 816-719-6765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.