Not provided
Not provided
Not provided
Not provided
Not provided
not able to recruit enough participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StO2 and EndoPAT | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Endopat |
Not provided
Inclusion Criteria:
Non-pregnant group:
Pregnant group:
Exclusion Criteria:
Non-pregnant group:
Pregnant group:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aymen Alilan | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06511 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
3 groups: healthy volunteers (15) and normotensive (10) and pre-eclamptic (10) pregnant women during their visit to labor floor.
Not provided
Not provided
Not provided
Not provided
|
|
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 | SphygmoCor is a measurement of vascular stiffness. This will only be measured in hypertensive pregnant participants. | 2, 6, 12 weeks (Postpartum) |