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Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions

NCT04548453 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-09-14

No results posted yet for this study

Summary

Patients receiving oxytocin for induction or augmentation of labor will be studied with uterine EMG. The results of the EMG will be converted to an oxytocin-associated uterine stimulation index (uSI), which is intended to guide decisions for changing the dose of oxytocin. An expert panel will review the results of the oxytocin dosing actions, then assigned optimized actions throughout the labor. The uSI will be correlated with the optimal dosing actions.

Conditions

  • Pregnancy Related
  • Labor Long
  • Fetal Distress

Interventions

DEVICE

uterine electromyography

Multichannel uterine electromyography will record uterine biosignals during labor.

Sponsors & Collaborators

  • PreTeL, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-10-31
Completion
2021-10-31
FDA Device
Yes

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 NCT04548453 on ClinicalTrials.gov