NCT06835647 Maternal Fetal Device Performance Twins
| NCT ID | NCT06835647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GE Healthcare |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-01-21 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Monica Rabanal, NP
PRINCIPAL INVESTIGATOR
Element Materials Technology
Frequently Asked Questions
Who can join the NCT06835647 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06835647 currently recruiting?
Yes, NCT06835647 is actively recruiting participants. Contact the research team at Amie.Robinson@gehealthcare.com for enrollment information.
Where is the NCT06835647 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT06835647 clinical trial?
NCT06835647 is sponsored by GE Healthcare. The principal investigator is Monica Rabanal, NP at Element Materials Technology. The trial plans to enroll 15 participants.