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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04142268
Other study ID # B-1402-240-006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2013
Est. completion date May 2017

Study information

Verified date October 2019
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date May 2017
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The differences in longitudinal change pattern of CAVI between preeclampsia and normal pregnant women. The CAVI was analyzed with generalized estimating equation (GEE) method to evaluate the different change pattern of CAVI between two groups. The CAVI was measured at one day, six months and one year after delivery in both groups.
Secondary Systolic blood pressure automated blood pressure, mmHg one day, six months and one year after delivery
Secondary Diastolic blood pressure automated blood pressure, mmHg one day, six months and one year after delivery
Secondary Body weight kilograms one day, six months and one year after delivery
Secondary Waist/Hip ratio Waist circumference in centimeter, Hip circumference in centimeter, Waist/Hip Circumference Ratio is the ratio of waist circumference divided by hip circumference one day, six months and one year after delivery
Secondary Lipid profiles (Total cholesterol, TG, LDL, HDL) mg/dL (milligrams per deciliter) one day, six months and one year after delivery
Secondary AST(aspartate aminotransferase), ALT(alanine aminotransferase) IU/L (International Units Per Litre) one day, six months and one year after delivery
Secondary Serum creatinine mg/dL (milligrams per deciliter) one day, six months and one year after delivery
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