Performance of the Monica Novii Wireless Patch System in Pre-term Labor
Completed
Conditions studied: Premature Labor
In brief
To study the equivalence of the Monica Novii™ Patch System in patients admitted for threatened pre-term labor and for pre-term labor \& delivery from 32 +0 weeks gestation by determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer (TOCO) UC and photo plethysmograph MHR FDA approved predicates.
Key facts
- Study ID
- NCT03057275
- Run by
- GE Healthcare
- People needed
- 47
- Starts
- 2017-04-20
- Expected to finish
- 2019-09-20
- Last updated by the study team
- 2021-02-09
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- She will require pre-term labor (at least 32 weeks 0 days gestation) monitoring with a singleton longitudinal, breech, transverse lie pregnancy.
- She had none of the exclusion criteria.
You may not qualify if…
- The presence of any of the following factors or conditions would exclude the patient from consideration as a subject:
- Known major fetal malformation or chromosome abnormality.
- Multiple gestation
- A condition for which cesarean will likely be carried out shortly.
- 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 would preclude the use of abdominal electrodes (e.g., skin eruptions, history of sensitivity to adhesives).
- Parturient is under age 18.
- 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 or diminished intellectual capacity, or insurmountable language barrier.
- Potential for coercion, e.g. Prisoners.
Where it is running
- University of Arizona Medical Center — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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