Perinatal Care
Conditions
Brief summary
This is a multicenter, prospective, investigational device study designed to evaluate: The safety, feasibility, and accuracy of the device, when used by pregnant individuals
Interventions
Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters
Sponsors
PulseNmore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Singleton gestation. * Gestational age \>14 weeks with a prior scan demonstrating fetal viability and confirming dates. * English or Spanish speaking. * Ability to understand and sign the informed consent (available in English and Spanish). * Ability to read and understand instructions that are required for equipment use (instructions available in both languages).
Exclusion criteria
* Multiple gestations. * BMI \>40. * Known fetal and genetic anomalies. * Subjects with skin problems in the abdominal area (such as wounds, cuts in the skin, and skin rash). * Subjects allergic to the ultrasound probe materials. * Non-English/ non-Spanish speaking. * Unable to provide consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of device derived presence or absence of fetal cardiac activity to ground truth | Test to be conducted during week 14-38 of pregnancy | The presence or absence of device derived fetal cardiac activity would be matched with the presence or absence of fetal cardiac activity derived by the ground truth (in-clinic ultrasound scan) |
| Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth | Test to be conducted during week 14-38 of pregnancy | Comparison of device derived amniotic fluid level status, normal or abnormal, (measured by maximal vertical pocket in cm) would be matched with amniotic fluid level status derived from the ground truth (in-clinic ultrasound scan) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to assess fetal presentation from device derived input will be compared to the ground truth | Test to be conducted during week 14-38 of pregnancy | Whether fetal presentation could be assessed or could not be assessed from device derived input compared to the input from ground truth (in-clinic ultrasound scan) |
| Ability to assess placental location from device derived input will be compared to the ground truth | Test to be conducted during week 14-38 of pregnancy | Whether placental location could be assessed or could not be assessed from device derived input compared to the input from ground truth (in-clinic ultrasound scan) |
| Ability to detect fetal movement from device derived input will be compared to the ground truth | Test to be conducted during week 14-38 of pregnancy | Whether fetal movement could be detected or could not be detected from device derived input compared to the input from ground truth (in-clinic ultrasound scan) |
| Ability to detect fetal breathing from device derived input will be compared to the ground truth | Test to be conducted during week >27-38 of pregnancy | Whether fetal breathing could be detected or could not be detected from device derived input compared to the input from ground truth (in-clinic ultrasound scan) |
Countries
United States
Outcome results
None listed