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

Blood Pressure Clinical Trial

Official title:

Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic and Normotensive Women After Delivery: One-Year Follow-Up Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142268
• Other study ID #: B-1402-240-006
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Blood Pressure
• Eclampsia
• Pre-Eclampsia
• Preeclampsia and Eclampsia
• Stiffness, Aortic

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