A Study to Assess the Safety and Efficacy of Pulsenmore ES Home Ultrasound Device in Pregnant Women
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Perinatal Care
- Sponsor
- PulseNmore
- Enrollment
- 188
- Locations
- 4
- Primary Endpoint
- Comparison of device derived presence or absence of fetal cardiac activity to ground truth
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
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.
- •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.
Outcomes
Primary Outcomes
Comparison of device derived presence or absence of fetal cardiac activity to ground truth
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)