Fetal Life: Smart-Device Based Uterine Activity Monitoring

NCT03940365 | Completed

• 1 other identifier: 19.0011
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Labor; Uterine contraction

Outcome Measures

Primary Outcomes (10)

• Number of contractions measured by Fetal Life tocometer in comparison with standard tocometer

  number of contractions and duration in seconds

  one hour of monitoring per subject

• Duration of contractions measured by Fetal Life tocometer in comparison with standard tocometer

  number of contractions and duration in seconds

  one hour of monitoring per subject

• Physical comfort of device in comparison with standard monitor

  Patient survey question: is the study device (black rectangle) more comfortable, less comfortable of the same in comfort as the routine monitor (white disk)?

  Survey on completion of one hour of monitoring

• Stability of device placement on abdomen in comparison with standard monitor

  Patient survey question: does the study device (black rectangle) stay where it positioned on your abdomen when you move around better than the routine monitor (white disk), less that the routine monitor or about the same as the routine monitor?

  Survey on completion of one hour of monitoring

• Preference for device over standard monitor

  Patient survey question: do you any preference for study device (black rectangle), the routine monitor (white disk) or no preference between the two?

  Survey on completion of one hour of monitoring

• Were directions clear to patient?

  Patient survey question: did you understand the direction for using the device? (yes/no)

  Survey completed by subject on completion of 15 minutes of monitoring

• Was patient able to position the device?

  Patient survey question: were you able to position the device on your abdomen? (yes/no)

  Survey completed by subject on completion of 15 minutes of monitoring

• Was patient able to pair the device with the app?

  Patient survey question: were you able to pair the device with the smart device app? (yes/no)

  Survey completed by subject on completion of 15 minutes of monitoring

• Was patient able to see their contractions on the app?

  Patient survey question: were you able to see your contractions on the smart device app? (yes/no)

  Survey completed by subject on completion of 15 minutes of monitoring

• Did contractions on the app correlate with the patient's experience?

  Patient survey question: did the information visible on the smart device app accurately reflect the contractions you were feeling? (yes/no)

  Survey completed by subject on completion of 15 minutes of monitoring

Study Arms (1)

Study Group

EXPERIMENTAL

As detailed above, a single group will be used for the study to compare the output of the study device with the output of the standard device in each patient.

Device: Fetal Life tocometer device

Interventions

Fetal Life tocometer device 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.

Study Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant patients on the Labor and Delivery unit
• Contracting every five minutes or more frequently by standard tocometry monitor
• Category 1 fetal heart tracing (reassuring tracing with moderate variability and no decelerations)
• Cervical examination completed and awaiting repeat examination in 2-4 hours
• weeks or greater
• Singleton pregnancy (not multiple gestation)
• Live fetus
• Undergoing tocometry monitoring with standard devices
• English speaking
• Age between 20 years and 40 years

You may not qualify if:

• Nonreassuring fetal heart tracing
• Any active skin lesions or infections

Sponsors & Collaborators

• Fetal Life LLC: lead
• University of Louisville: collaborator

Study Sites (1)

University Hospital, University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (3)

• Lewis D, Downe S; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Intermittent auscultation. Int J Gynaecol Obstet. 2015 Oct;131(1):9-12. doi: 10.1016/j.ijgo.2015.06.019. No abstract available.

  PMID: 26433400 BACKGROUND

• Hoffman E.B., Sen, P.K., Weinberg, C.R. Within-cluster resampling. Biometrika (2001), 88(4): 1121-1134.

  BACKGROUND

• Lorenz DJ, Levy S, Datta S. Inferring marginal association with paired and unpaired clustered data. Stat Methods Med Res. 2018 Jun;27(6):1806-1817. doi: 10.1177/0962280216669184. Epub 2016 Sep 20.

  PMID: 27655806 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara Petruska, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The study will use a single group for the intervention as detailed above.

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: May 7, 2019
• Study Start: May 15, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)