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

• Conditions: Endothelial Dysfunction
• Interventions: Other: Observational only

• Registration Number: NCT02334839
• Lead Sponsor: Rabin Medical Center

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.

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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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-01
• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-06
• Last Update Submitted: 2015-01-06
• Study First Posted: 2015-01-08
• Last Update Posted: 2015-01-08
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
gestational hypertension	Observational only	women with diagnosed gestational hypertension without preeclampsia
healthy	Observational only	women without gestational hypertension or preeclampsia
Preeclampsia	Observational only	women with diagnosed preeclampsia

Primary Outcome Measures

Name	Time	Method
Reactive Hyperemia Index (RHI)	24 months	The difference in Reactive Hyperemia Index (RHI) as messureas using the ENDOPAT device between the study groups

Trial Locations

Locations (1)

Rabin medical center; 🇮🇱 Petah Tiqwa, Israel