NCT05782296

Brief Summary

A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
2 countries

3 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

Study Start

First participant enrolled

February 24, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

February 28, 2022

Last Update Submit

March 24, 2025

Conditions

Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During LaborUterine ContractionsObstetric Complication

Keywords

Fetal Heart RateUterine ActivityTrueLaborOB ToolsNon invasive monitoring

Outcome Measures

Primary Outcomes (2)

  • Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate

    This will be performed using a Performance Goal

    Through labor, until delivery

  • Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity

    This will be performed using a Performance Goal

    Through labor, until delivery

Secondary Outcomes (1)

  • Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2)

    Through labor, until delivery

Study Arms (1)

Cohort

Women in active labor following rupture of membranes and placement of an IUPC and/or FSE for obstetric indications

Device: TrueLabor

Interventions

TrueLaborDEVICE

Non invasive monitoring device

Cohort

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen in active labor
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women (age\>18 y/o) in active labor following rupture of membranes and placement of an IUPC and/or FSE.

You may qualify if:

  • Women who are on \>=37w0d of gestation
  • Maternal age \> 18 years old
  • Singleton pregnancy
  • Cephalic presentation
  • Patient requiring internal monitoring for obstetric indications
  • Informed consent

You may not qualify if:

  • Major fetal anomalies
  • Patients with implanted electronic devices of any kind
  • Patients using exterior electronic devices of any kind during the procedure
  • Patients with irritated skin or open wound on the abdominal wall

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ascension Illinois Saint Alexius Residency Program in Obstetrics and Gynecology

Hoffman Estates, Illinois, 60169, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Meir Medical Center

Kfar Saba, Israel

Location

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 23, 2023

Study Start

February 24, 2022

Primary Completion

June 5, 2024

Study Completion

June 5, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)IL(1)