MedTrace Logo

Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

NCT03196141 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-07-12

No results posted yet for this study

Summary

The purpose of this study is to compare 3 methods of assessing endothelial function in healthy female volunteers and pregnant women with and without pregnancy induced hypertension. The methods under comparison are simultaneous tissue oxygen saturation (StO2), EndoPAT and Sphygmocor (pregnant women only). 35 participants (15 healthy, 10 pregnant normal blood pressure, 10 pregnant with hypertension) will be enrolled.

Conditions

  • Pre-Eclampsia

Interventions

DIAGNOSTIC_TEST

StO2 and EndoPAT

* StO2 probe is a lightweight plastic probe that will be applied over the brachioradilalis muscle (anterolatereal aspect of the forearm) where there is less subcutaneous fat and taped in place. * The EndoPAT probe will be place on a finger on the same arm. * Pulse oximeter probes will be connected to a finger on each hand.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Aymen Alilan · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-10-01
Completion
2019-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03196141 on ClinicalTrials.gov