Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

Not Applicable

Withdrawn

• Conditions: Pre-Eclampsia

• Registration Number: NCT03196141
• Lead Sponsor: Yale University

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.

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 Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Study Start: 2018-10-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-12
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
StO2	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.
SphygmoCor	48 Hours (Postpartum)	SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.
Endopat	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.

Secondary Outcome Measures

Name	Time	Method
Endopat	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.
SphygmoCor	2, 6, 12 weeks (Postpartum)	SphygmoCor is a measurement of vascular stiffness. This will only be measured in hypertensive pregnant participants.
StO2	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.

Trial Locations

Locations (1)

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States