NCT03889405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 8, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

March 18, 2019

Last Update Submit

February 5, 2021

Conditions

Healthy, Pregnant Women

Outcome Measures

Primary Outcomes (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.

    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.

    30-60 minutes per participant

Study Arms (1)

Study group

EXPERIMENTAL

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

Device: INVU™Device: IUPCDevice: TOCO

Interventions

INVU™DEVICE

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

Study group
IUPCDEVICE

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

Study group
TOCODEVICE

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

Also known as: CTG
Study group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy participants are healthy, pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 34762863DERIVED

Study Officials

  • Nadav Schwartz, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Curtis Lowery, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 26, 2019

Study Start

April 9, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

February 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)