Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

NCT03196141 | Withdrawn FDA Device

• 1 other identifier: 2000020110
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• StO2

  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

  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

  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

  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

  SphygmoCor is a measurement of vascular stiffness. This will only be measured in pregnant participants.

  Baseline

• SphygmoCor

  SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.

  48 Hours (Postpartum)

Secondary Outcomes (3)

• StO2

  2, 6, 12 weeks (Postpartum)

• Endopat

  2, 6, 12 weeks (Postpartum)

• SphygmoCor

  2, 6, 12 weeks (Postpartum)

Study Arms (3)

Healthy volunteers

ACTIVE COMPARATOR

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

Pregnant women with normal BP

ACTIVE COMPARATOR

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

Pregnant women with high BP

ACTIVE COMPARATOR

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

Interventions

StO2 and EndoPAT DIAGNOSTIC_TEST

* 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.

Healthy volunteers; Pregnant women with high BP; Pregnant women with normal BP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pregnant group:
• \> 18 years of age
• Male or female
• Pregnant group:
• \> 18 years of age
• Pregnant women \> 20 weeks
• 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.
• Normotensive, not meeting criteria in #3

You may not qualify if:

• Non-pregnant group:
• Raynaud's Disease
• Adhesive tape allergy
• Recent Myocardial Infarction (\< 3 months)
• Congestive Heart Failure
• Pregnant group:
• Raynaud's Disease
• Adhesive tape allergy
• Recent Myocardial Infarction (\< 3 months)
• Congestive Heart Failure
• Hemodynamically unstable (SBP \< 90 mmHg)
• Fetal distress

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aymen Alilan

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 groups: healthy volunteers (15) and normotensive (10) and pre-eclamptic (10) pregnant women during their visit to labor floor.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)