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

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02334839
• Other study ID #: 0206-14
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2015
• Last updated: January 6, 2015
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2015
• Source: Rabin Medical Center
• Contact: Liran Hiersch
• Phone: +972-3-9377490
• Email: liranh[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Maternal age 18-40 years old

2. 27 and above weeks of gestation

3. Singleton pregnancy

4. Agreed to participate in the study and signed on informed consent form.

Exclusion Criteria:

1. Known ischemic heart disease or angina pectoris

2. Active smoker

3. Dyslipidemia, chronic hypertension. Renal disease, diabetes mellitus (gestational or pregestational)

4. Active treatment with anti-hypertensive medication, anti-aggregation medication or lipid lowering agents.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin medical center	Petah Tiqwa

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactive Hyperemia Index (RHI)	The difference in Reactive Hyperemia Index (RHI) as messureas using the ENDOPAT device between the study groups	24 months	No