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

NCT ID: NCT03889405

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-09
• Study Completion Date: 2020-01-31

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.

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.

Conditions

Healthy, Pregnant Women

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study group

Healthy 32 weeks or more pregnant women, at an early stage of labor.

Group Type: EXPERIMENTAL

INVU™

Intervention Type: DEVICE

The subject will undergo continuous recording of the uterine contractions and the fetal heart rate (FHR) for 30 to 60 min using INVU™.

IUPC

Intervention Type: DEVICE

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

TOCO

Intervention Type: DEVICE

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

Interventions

INVU™

The subject will undergo continuous recording of the uterine contractions and the fetal heart rate (FHR) for 30 to 60 min using INVU™.

Intervention Type: DEVICE

IUPC

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

CTG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nuvo-Group, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadav Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Curtis Lowery, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Schwartz N, Mhajna M, Moody HL, Zahar Y, Shkolnik K, Reches A, Lowery CL Jr. Novel uterine contraction monitoring to enable remote, self-administered nonstress testing. Am J Obstet Gynecol. 2022 Apr;226(4):554.e1-554.e12. doi: 10.1016/j.ajog.2021.11.018. Epub 2021 Nov 8.

Reference Type: DERIVED

PMID: 34762863 (View on PubMed)

Other Identifiers

CLP-2000

Identifier Type: -

Identifier Source: org_study_id