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Comparative Performance of INVU™ Versus Intrauterine Pressure Catheter (IUPC) in Uterine Contractions Monitoring of Pregnant Women.

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ClinicalTrials.gov Identifier: NCT03889405
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Nuvo-Group, Ltd.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy, Pregnant Women Device: INVU™ Device: IUPC Device: TOCO Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Study Evaluating the Safety of Invu ™ and Comparative Performance of Invu ™ Versus IUPC in Prenatal Monitoring of Pregnant Subjects With Uterine Contractions.
Actual Study Start Date : April 9, 2019
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
Healthy 32 weeks or more pregnant women, at an early stage of labor.
 Device: INVU™
The subject will undergo continuous recording of the uterine contractions and the fetal heart rate (FHR) for 30 to 60 min using INVU™.

Device: IUPC
The study participants will undergo continuous recording of the uterine contractions by IUPC.

Device: TOCO
Some of the study participants will undergo continuous recording of the uterine contractions and the fetal heart rate (FHR) by TOCO as well.
Other Name: CTG


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the agreement between INVU™ and IUPC (the gold standard) during monitoring of uterine contractions as well as the agreement between Cardiotocography (TOCO) and IUPC, where applicable. [ Time Frame: 30-60 minutes per participant ]
    Three blinded assessors will review the uterine contractions output data (the recordings) from the monitoring devices and determine for each time point whether a contraction occurred. The assessors will not have visibility to the source of the recorded data. Each assessor will review the sessions in a randomized order, while the evaluation will include: a contraction start point, peak, and endpoint. The actual presence of a contraction will be determined by the IUPC.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study participants are healthy, pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889405


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Nuvo-Group, Ltd.
Investigators
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Principal Investigator: Nadav Schwartz, MD University of Pennsylvania
Principal Investigator: Curtis Lowery, MD University of Arkansas
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nuvo-Group, Ltd.
ClinicalTrials.gov Identifier: NCT03889405    
Other Study ID Numbers: CLP-2000
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes