Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor

The primary objective of the Prentice study is to assess and validate EMG performance of the new home-use sensor with extended battery life in detecting continuous EHG in a range of uterine contraction intensities, frequencies, and durations compared to gold-standard FDA-cleared tocodynamometer (GE Corometrics 250cx) in non-stress testing for antepartum surveillance.

An "at-home" study will validate the developed modifications to the wearable sensors system that provides a continuous electrohysterography (EHG) along with other additional physiological parameters (e.g. heart rate, heart rate variability, sleep quality, physical activity, and continuous blood pressure) for longitudinal monitoring in the home setting.

• Maternal age >18 years old
• Pregnant mothers >13 weeks (home study only)
• Pregnant mothers >26 weeks undergoing nonstress testing or delivering
• Singleton pregnancy (inpatient or clinic visit patients only)
• History of preterm labor or premature birth, active smoker, chronic condition (ex: HTN or DM), or an interval of less than 6 months between the prior pregnancy
• Singleton pregnancy (home study only)
• No fetal abnormality or chromosomal abnormality
• Subjects willing and able to comply with requirements of the protocol

Exclusion criteria

• Women who refuse to signed the informed consent form
• Maternal age under 18 years old
• Multiple pregnancy
• Known major fetal malformation or chromosomal abnormality
• Medical or obstetric problem that would preclude the use of abdominal electrodes
• Inability to consent to this study due to medical illness, diminished intellectual capacity, or language barrier
• Women using pacemakers