Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

July 9, 2019 updated by: Yale University

Perioperative Clinical Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In both normotensive women and others with pregnancy induced hypertension, in previous research simultaneous tissue oxygen saturation (StO2) were measured in both forearms, with a blood pressure cuff above the tissue oximetry probe on one side.

StO2 values were continuously monitored on each side during unilateral blood pressure (BP) cuff inflation (to suprasystolic pressure for 3 min), and then during deflation. Despite similarity in the forearm StO2 decline observed with cuff inflation in all women, the rise following cuff deflation - indicative of reactive hyperemia - appeared reduced in hypertensive patients, suggesting a relationship with impaired endothelial reserve.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale-New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Non-pregnant group:

  1. > 18 years of age
  2. Male or female

Pregnant group:

  1. > 18 years of age
  2. Pregnant women > 20 weeks
  3. Diagnosis of Pre-eclampsia characterized as Systolic BP > 140 mmHg, diastolic BP > 90 mmHg after 20 weeks of gestation accompanied by new onset of proteinuria.
  4. Normotensive, not meeting criteria in #3

Exclusion Criteria:

Non-pregnant group:

  1. Raynaud's Disease
  2. Adhesive tape allergy
  3. Recent Myocardial Infarction (< 3 months)
  4. Congestive Heart Failure

Pregnant group:

  1. Raynaud's Disease
  2. Adhesive tape allergy
  3. Recent Myocardial Infarction (< 3 months)
  4. Congestive Heart Failure
  5. Hemodynamically unstable (SBP < 90 mmHg)
  6. Fetal distress

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Healthy volunteers

Part#1: 15 healthy volunteers; 2 assessment sessions. Session 1: StO2 vs. EndoPAT Method comparison analysis; both StO2 and EndoPAT will be applied simultaneously & pulse oximeter probes placed bilaterally on fingers. Baseline readings will be taken for 5 minutes. The blood pressure cuff will be inflated to suprasystolic pressure and StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions.

Session 2: This session will occur within 1 week of session 1. This session is to determine the consistency of the response.

All probes will be applied as in session 1 and cycles of 10 minutes for 3 sessions will be done. All the measurements in session 1 will be captured in session 2.

This will determine inter-day variability. (total time is 53 min).
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.
Active Comparator: Pregnant women with normal BP

Part #2: 20 participants, 10 normotensive and 10 pre-eclamptic pregnant women during their visit to labor floor.

Session 1: Both StO2 and EndoPAT will be applied simultaneously to the same arm below a BP cuff. Baseline readings will be taken for 5 minutes, the blood pressure cuff will be inflated to suprasystolic pressure StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions.

Additionally, vascular stiffness with be measured by SphygmoCor to measure pulse wave velocity (PWV).

Participants must also agree to participate OB/GYN biobanking protocol HIC# 1601017004 to be in this study.

All participants will have follow-up at 48 hours, including a blood draw, assessment of endothelial function and vascular stiffness.
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.
Active Comparator: Pregnant women with high BP

Part #2: 20 participants, 10 normotensive and 10 pre-eclamptic pregnant women during their visit to labor floor.

Session 1: Both StO2 and EndoPAT will be applied simultaneously to the same arm below a BP cuff. Baseline readings will be taken for 5 minutes, the blood pressure cuff will be inflated to suprasystolic pressure StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions.

Additionally, vascular stiffness with be measured by SphygmoCor to measure pulse wave velocity (PWV).

Participants must also agree to participate OB/GYN biobanking protocol HIC# 1601017004 to be in this study.

All participants will have follow-up at 48 hours, including a blood draw, assessment of endothelial function and vascular stiffness.

Participants with hypertension will be followed in conjunction with routine clinical follow-up at 2, 6 and 12 weeks post-partum.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
StO2
Time Frame: Baseline
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. Baseline measures are collected in healthy and pregnant participants.
Baseline
StO2
Time Frame: 48 Hours (Postpartum)
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in pregnant participants.
48 Hours (Postpartum)
Endopat
Time Frame: Baseline
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. Baseline measures are collected in healthy and pregnant participants.
Baseline
Endopat
Time Frame: 48 Hours (Postpartum)
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in pregnant participants.
48 Hours (Postpartum)
SphygmoCor
Time Frame: Baseline
SphygmoCor is a measurement of vascular stiffness. This will only be measured in pregnant participants.
Baseline
SphygmoCor
Time Frame: 48 Hours (Postpartum)
SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.
48 Hours (Postpartum)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
StO2
Time Frame: 2, 6, 12 weeks (Postpartum)
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in hypertensive pregnant participants.
2, 6, 12 weeks (Postpartum)
Endopat
Time Frame: 2, 6, 12 weeks (Postpartum)
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in hypertensive pregnant participants.
2, 6, 12 weeks (Postpartum)
SphygmoCor
Time Frame: 2, 6, 12 weeks (Postpartum)
SphygmoCor is a measurement of vascular stiffness. This will only be measured in hypertensive pregnant participants.
2, 6, 12 weeks (Postpartum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aymen Alilan, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000020110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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