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Fetal Life: Smart-Device Based Uterine Activity Monitoring

NCT03940365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-01-26

No results posted yet for this study

Summary

This study will compare the performance of a contraction monitor (tocometer) device developed by Fetal Life with standard tocometer devices.

The study aims to test a uterine contraction monitor that can be applied by the patient to her abdomen and connected to her smart device to detect the frequency and duration of uterine contractions. Phase 1 will collect data for calibration of the monitor and for a noninferiority study comparing the Fetal Life uterine contraction monitor (tocometer) with standard tocometry devices. Phase 2 will be a feasibility study in which patients will position the monitor, connect to the corresponding Fetal Life app and measure their own uterine contraction activity.

The study's hypothesis is that after calibration, the new monitor will reliably detect at least 95% of the number and duration of contractions detected by the standard monitor, and that the device will perform comparably whether applied by the patient or by research staff.

Conditions

  • Labor Pain
  • Contraction

Interventions

DEVICE

Fetal Life tocometer device

The fetal life tocometer device is a uterine contraction monitor which is less expensive to manufacture than existing contraction monitor devices and which pairs with a smart device rather than a bulky output device.

Sponsors & Collaborators

  • University of Louisville

    collaborator OTHER

  • Fetal Life LLC

    lead INDUSTRY

Principal Investigators

  • Sara Petruska, MD · University of Louisville

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2021-03-31
Completion
2021-03-31

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 NCT03940365 on ClinicalTrials.gov