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

NCT02334839 | Unknown DMC

• 1 other identifier: 0206-14
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. .

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Reactive Hyperemia Index (RHI)

  The difference in Reactive Hyperemia Index (RHI) as messureas using the ENDOPAT device between the study groups

  24 months

Study Arms (3)

Preeclampsia

women with diagnosed preeclampsia

Other: Observational only

gestational hypertension

women with diagnosed gestational hypertension without preeclampsia

Other: Observational only

healthy

women without gestational hypertension or preeclampsia

Other: Observational only

Interventions

Observational only OTHER

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.

Preeclampsia; gestational hypertension; healthy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A prospective cohort study of approximately 150 gravidas who are hospitalized in maternal-fetal medicine (MFM) ward in Rabin Medical Center in Israel.

You may qualify if:

• Maternal age 18-40 years old
• and above weeks of gestation
• Singleton pregnancy
• Agreed to participate in the study and signed on informed consent form.

You may not qualify if:

• Known ischemic heart disease or angina pectoris
• Active smoker
• Dyslipidemia, chronic hypertension. Renal disease, diabetes mellitus (gestational or pregestational)
• Active treatment with anti-hypertensive medication, anti-aggregation medication or lipid lowering agents.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin medical center

Petah Tikva, 49100, Israel

RECRUITING

Study Officials

• Liran Hiersch

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liran Hiersch

CONTACT

+972-3-9377490; liranh@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

IL (1)