Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic Women After Delivery

Completed

• Conditions: Preeclampsia and Eclampsia; Blood Pressure; Stiffness, Aortic

• Registration Number: NCT04142268
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The investigator measured the arterial stiffness using cardio-ankle vascular index (CAVI) test in patient with preeclampsia and normal pregnant women to evaluate the longitudinal change of CAVI and their predictors.

Detailed Description

This study was a case control study and included 37 women with preeclampsia (PE group) and 36 normotensive women (control group) who gave birth to child at Seoul National University Bundang Hospital.

Cario-ankle vasuclar index (CAVI) was measured at one day, six months and one year after delivery in both group.

The investigator also checked the body weight, blood pressure, lipid profile, serum creatinine, aspartate transaminase (AST) and alanine transaminase (ALT) simultaneously with CAVI.

The relationship between the presence of preelampsia and longitudinal changes of CAVI, blood pressure and metabolic indices were evaluated using generalized estimating equation (GEE) method.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2016-10
• Study Completion: 2017-05
• Status Verified: 2019-10
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-26
• Last Update Submitted: 2019-10-26
• Study First Posted: 2019-10-29
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

Inclusion Criteria

1. Case group : Women who were diagnosed preeclampsia based on the criteria of the International Society for the Study of Hypertension in Pregnancy
2. Control group : Normotensive women who gave birth to child at Seoul National University Bundang Hospital.

Exclusion Criteria

• Women who were hemodynamically compromised or had bleeding complication after delivery were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The differences in longitudinal change pattern of CAVI between preeclampsia and normal pregnant women.	The CAVI was measured at one day, six months and one year after delivery in both groups.	The CAVI was analyzed with generalized estimating equation (GEE) method to evaluate the different change pattern of CAVI between two groups.

Secondary Outcome Measures

Name	Time	Method
Diastolic blood pressure	one day, six months and one year after delivery	automated blood pressure, mmHg
Body weight	one day, six months and one year after delivery	kilograms
Lipid profiles (Total cholesterol, TG, LDL, HDL)	one day, six months and one year after delivery	mg/dL (milligrams per deciliter)
Waist/Hip ratio	one day, six months and one year after delivery	Waist circumference in centimeter, Hip circumference in centimeter, Waist/Hip Circumference Ratio is the ratio of waist circumference divided by hip circumference
Systolic blood pressure	one day, six months and one year after delivery	automated blood pressure, mmHg
AST(aspartate aminotransferase), ALT(alanine aminotransferase)	one day, six months and one year after delivery	IU/L (International Units Per Litre)
Serum creatinine	one day, six months and one year after delivery	mg/dL (milligrams per deciliter)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of