Performance of the Monica Novii Wireless Patch System in Pre-term Labor

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 to artefact or error in a Pre-Term Labor population,
the principal investigator or a member of the study team will decide on:

1. One 30 minute period of 'interpretable' Doppler FHR, photo plethysmograph MHR and TOCO
UA from each of the admitted threatened pre-term labor subjects, when the subject is
experiencing contractions as demonstrated by the TOCO UC trace and these contractions
represent the clinical presentation.

2. One 30 minute period of 'interpretable' Doppler FHR, photo plethysmograph MHR and TOCO
UA from each of the pre-term labor & delivery subjects ending as close to delivery as
practical. As above the TOCO UC contractions should represent the clinical presentation.

The selection of the 30 min periods will be based on data from the predicate only (the Novii
FHR and UC data will not be available to the study team).

The two 30 min periods will be used for the statistical equivalence calculation. All recorded
data will be made available for visual review.

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.