Clinical Trial

Fetal Life: Smart-Device Based Uterine Activity Monitoring

Study Description

Fetal Life: Smart-Device Based Uterine Activity Monitoring

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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.

Additional Information

Official Study Title

Fetal Life: Calibration, Noninferiority and Feasibility Studies for Smart-Device Based Uterine Activity Monitoring

Clinical Trial ID

NCT03940365

ParticipAid ID

en5j5d