Maternal Fetal Device Performance Twins (NCT06835647)
Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (5 items).
Location: Element Materials Technology — Louisville, Colorado
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Non-twin pregnancy.
- Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
- Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.
- Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Element Materials Technology — Louisville, Colorado
📞 Contact the Study Coordinator
Phone: (816) 719-6765
Email: Amie.Robinson@gehealthcare.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.