Comparative Performance of INVU™ Versus Intrauterine Pressure Catheter (IUPC) in Uterine Contractions Monitoring of Pregnant Women.
Purpose
The primary objective of this research is to assess the agreement between INVU™ and IUPC (the gold standard) during prenatal monitoring of uterine contractions and to assess the safety of INVU™. Additional information comparing INVU™ to TOCO (the standard of care) was also collected.
Condition
- Healthy, Pregnant Women
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Female age between 18-50 - Gestational age ≥32 + 0 weeks - Singleton gestation - Ability to understand and sign informed consent - The subject is within the first stage labor, including early, active and transition phases (cervix is dilated up to 10 cm) - The subject has an IUPC in place for clinical contraction monitoring -
Exclusion Criteria
- BMI ≥50 and 15≤ prior pregnancy (Body Mass Index) - Multiple gestation - Uncontrolled Hypertension - Known fetal Anomaly (i.e. major structural) - 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 judgment of the investigator, are likely to be non-compliant or uncooperative during the study - Subject who is within the second stage labor (cervix is fully dilated to 10 cm or going into the second stage of labor or more)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Study group |
Healthy 32 weeks or more pregnant women, at an early stage of labor. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03889405
- Status
- Completed
- Sponsor
- Nuvo-Group, Ltd.
Detailed Description
This multi-center, prospective, comparative, open-label study will be performed in two steps: A training step where up to 40 subjects will be enrolled to confirm uterine contraction performance level. In the second, validation step, the performance of the uterine contraction detection algorithm will be validated. The validation phase will involve up to 80 subjects. Sub-study will be implemented in the sites that will monitor the uterine activity of the subjects with TOCO, in addition to INVU™ and IUPC. Following the screening process, participants subject will undergo continuous recording of the uterine contraction and the fetal heart rate (FHR) for 30 to 60 min using INVU™, Cardiotocograph ((TOCO / CTG), and Intrauterine Pressure Catheters (IUPC). The collected data will be downloaded and comprehensive analysis of the values will be performed offline. Each participant will undergo continuous monitoring by the medical team to identify any safety issue, including but not limited to irritation, sensitization, and potential harmful misuse.