N/A
Completed N=151
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
Source: ClinicalTrials.gov NCT03504189 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Fetal Heart Rate — 140.3; 140.4 bpm
Summary
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fetal Heart Rate |
140.3; 140.4 | — |
| PRIMARY Maternal Heart Rate |
89.3; 89.1 | — |
| SECONDARY Uterine Contractions |
— | — |
Eligibility Criteria
Inclusion Criteria
- Female age between 18-50
- Gestational age > 32 + 0 weeks
- Singleton gestation
- Ability to understand and sign informed consent
Exclusion Criteria
- BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy
- Multiple gestation
- Uncontrolled Hypertension
- Fetal Anomaly
- Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
- Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
- Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study
Data sourced from ClinicalTrials.gov (NCT03504189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.