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

NCT03889405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-02-08

No results posted yet for this study

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.

Conditions

  • Healthy, Pregnant Women

Interventions

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.

Sponsors & Collaborators

  • Nuvo-Group, Ltd.

    lead INDUSTRY

Principal Investigators

  • Nadav Schwartz, MD · University of Pennsylvania

  • Curtis Lowery, MD · University of Arkansas

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2020-01-31
Completion
2020-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03889405 on ClinicalTrials.gov