Pre-Eclampsia
Conditions
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.
Interventions
DIAGNOSTIC_TESTStO2 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
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
3 groups: healthy volunteers (15) and normotensive (10) and pre-eclamptic (10) pregnant women during their visit to labor floor.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| StO2 | 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. |
| Endopat | 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. |
| SphygmoCor | Baseline | SphygmoCor is a measurement of vascular stiffness. This will only be measured in pregnant participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed