Performance of the Monica Novii Wireless Patch System in Threatened and Actual Pre-Term Labour

Launched by MONICA HEALTHCARE LTD · Jul 17, 2017

Keywords

ClinConnect Summary

The study is a single-center prospective paired comparison trial, to determine the equivalence of the Monica Novii Patch System with FDA cleared Doppler FHR, TOCO UC and photo plethysmograph MHR Predicate. Patients admitted for threatened pre-term labor and for pre-term labour \& delivery will be monitored with both devices simultaneously for FHR, UC, and MHR. Only the data from predicate devices will be available to the clinical care team. The equivalence of the Novii data will be compared to that of the simultaneously obtained predicate device data. Since TOCO UC and Doppler FHR are prone...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• 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.