RECRUITING
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Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
Conditions:
🦠 Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor 🦠 Uterine Contractions 🦠 Obstetric Complication
🗓️ Study Start (Actual) 24 February 2022
🗓️ Primary Completion (Estimated) 30 April 2024
✅ Study Completion (Estimated) 30 April 2024
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Hoffman Estates, Illinois, United States
📍 Bronx, New York, United States
📍 Kfar Saba, Israel

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 February 2022
  • First Submitted that Met QC Criteria 12 March 2023
  • First Posted 23 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 April 2024
  • Last Update Posted 3 April 2024
  • Last Verified April 2024
I'm interested ...!!