NCT02334839

The Association Between Severity of Hypertensive Disorder During Pregnancy and Endothelial Dysfunction

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Preeclampsia toxemia (PET) is a pregnancy related complication that is usually expressed as new onset hypertension and proteinuria after 20 weeks of gestation. scarce data exists regarding the effectiveness of PAT plethysmography use in women with PET and whether adverse results are found compared to healthy gravidas. Thus, we aimed to assess endothelial function using PAT plethysmography in women with PET and compare their results to both healthy gravidas and those with only gestational hypertension. .

Detailed description

Preeclampsia toxemia (PET) is a pregnancy related complication that is usually expressed as new onset hypertension and proteinuria after 20 weeks of gestation. Although the exact pathophysiology is unclear, it's related to abnormal placentation and subsequent vascular pathology. Endothelial dysfunction was found to play a significant role in the risk of cardiovascular event in general. Moreover, few studies found a relation between endothelial dysfunction and PET. There are several methods for the assessment of endothelial function, with Peripheral Artery Tone (PAT) plethysmography being an emerging non-invasive promising technique. However, scarce data exists regarding the effectiveness of PAT plethysmography use in women with PET and whether adverse results are found compared to healthy gravidas. Thus, we aimed to assess endothelial function using PAT plethysmography in women with PET and compare their results to both healthy gravidas and those with only gestational hypertension.

Conditions

• Endothelial Dysfunction

Interventions

Type	Name	Description
OTHER	Observational only	Endothelial function will be assessed using ENDO-PAT (Itamar medical LTD, Caesarea, Israel) device, which evaluates the change in peripheral vascular tone in reaction to temporal ischemia in a process called Reactive Hyperemia (RH) .The RH-PAT is a blood pressure measurement-like cuff which is placed on the non-dominant arm. A pneumatic probe is placed on the index finger bilaterally (one serves as a control). After a baseline assessment for a 5 minutes period, the cuff is inflated to a 60mm Hg pressure above the systolic pressure in order to occlude the arterial flow distal to the brachial artery. After 5 minutes of occlusion, a prompt deflation of the cuff results in a RH response and vasodilatation in the distal arteries including those monitored in the index finger. The sensor translates the change in vascular tone and the ENDO-PAT V3.0.4 device analyzes the data automatically. The results are given in a RH index scale that reflects the level of reactive hyperemia.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-01-08
• Last updated: 2015-01-08

Locations

1 site across 1 country: Israel