Pregnancy Preterm
Conditions
Brief summary
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
Detailed description
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.
Interventions
vital signs monitoring during maternal non-stress testing or in the home setting
Sponsors
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device comparison to standard monitoring | 2 years | The primary outcome measure is concordance of FHR tracing assessments from Rogers sensor recordings with those obtained from the current standard of care electronic fetal monitoring systems. |
Countries
United States
Outcome results
None listed