Clinical trial NCT03196141: Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women
Official title: Perioperative Clinical Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups: healthy volunteers (15) and normotensive (10) and pre-eclamptic (10) pregnant women during their visit to labor floor.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: StO2
timeFrame: Baseline
measure: StO2
timeFrame: 48 Hours (Postpartum)
measure: Endopat
timeFrame: Baseline
measure: Endopat
timeFrame: 48 Hours (Postpartum)
measure: SphygmoCor
timeFrame: Baseline
measure: SphygmoCor
timeFrame: 48 Hours (Postpartum)
Secondary outcomes:
measure: StO2
timeFrame: 2, 6, 12 weeks (Postpartum)
measure: Endopat
timeFrame: 2, 6, 12 weeks (Postpartum)
measure: SphygmoCor
timeFrame: 2, 6, 12 weeks (Postpartum)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Aymen Alilan
role: PRINCIPAL_INVESTIGATOR
References: