Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03196141
• Other study ID #: 2000020110
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

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.

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	SphygmoCor	SphygmoCor is a measurement of vascular stiffness. This will only be measured in pregnant participants.	Baseline
Primary	SphygmoCor	SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.	48 Hours (Postpartum)
Secondary	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 hypertensive pregnant participants.	2, 6, 12 weeks (Postpartum)
Secondary	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 hypertensive pregnant participants.	2, 6, 12 weeks (Postpartum)
Secondary	SphygmoCor	SphygmoCor is a measurement of vascular stiffness. This will only be measured in hypertensive pregnant participants.	2, 6, 12 weeks (Postpartum)