This will be a multi-center, prospective, comparative, open label sample size adaptive study.
The study will be performed in two steps: A training step where up to 30 subjects will be enrolled to confirm uterine contraction performance level.
The study will then be paused for around 45 days to complete validation and code freeze; a protocol amendment will be implemented if applicable.
In the second step, performance of the uterine contraction detection algorithm will be validated. The validation phase will involve up to 80 subjects, as the study will follow a sample size adaptive design with one interim analysis planned to allow for sample size increase or completion per original sample size.
Full Title of Study: “Clinical Study Evaluating the Safety of Invu ™ and Comparative Performance of Invu ™ Versus IUPC in Prenatal Monitoring of Pregnant Subjects With Uterine Contractions.”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: March 3, 2020
- Device: Invu
- The subject will undergo continuous recording of the uterine contraction and the fetal heart rate (FHR) for 30 to 60 min using Invu™ , Cardiotocograph (CTG) and Intrauterine Pressure Catheters (IUPC).
Arms, Groups and Cohorts
- Experimental: Study group
- Healthy 32 weeks or more pregnant women, at early stage of labor.
Clinical Trial Outcome Measures
- To achieve high agreement in comparison between Invu TM and the IUPC monitoring in detecting uterine contractions (defined by time start and end, and duration).
- Time Frame: 1.5 hours per subject
- Uterine contractions output data will be reviewed by 3 blinded assessors. The contractions will be marked upon the output strips. Time (start and end) and duration of contractions will be compared in order to evaluate the agreement between two parallel defined contractions from both different devices (Gold Standard IUPC and Study Device (Invu™) for the same subject. The total number of contractions collected from all subjects will be compared; recording will be performed during a 30-60 minutes session (number of contractions can vary for subject, but at least one contraction per subject is required).
Participating in This Clinical Trial
- 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
- 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)
Gender Eligibility: Female
Study subjects can only be pregnant women
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Nuvo-Group, Ltd.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Nadav Schwartz, MD, Principal Investigator, University of Pennsylvania
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