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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

This study included 37 women with preeclampsia (PE group) and 36 normotensive women (control group) who gave birth to child at Seoul National University Bundang Hospital from March 2013 to May 2016.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Preeclampsia group; PE was defined as diastolic BP of at least 110 mmHg on one occasion or diastolic BP of at least 90 mmHg on two consecutive occasions more than 4 hours apart, in combination with proteinuria (≥300 mg total protein in a 24-hour urine collection and, if this was not available, ≥+2 proteinuria by dipstick analysis on two consecutive occasions at least 4 hours apart) that develops after 20 weeks of gestation in previously normotensive women
Control group; Normal pregnancy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	automated blood pressure, mmHg	one day, six months and one year after delivery
Diastolic blood pressure	automated blood pressure, mmHg	one day, six months and one year after delivery
Body weight	kilograms	one day, six months and one year after delivery
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
Lipid profiles (Total cholesterol, TG, LDL, HDL)	mg/dL (milligrams per deciliter)	one day, six months and one year after delivery
AST(aspartate aminotransferase), ALT(alanine aminotransferase)	IU/L (International Units Per Litre)	one day, six months and one year after delivery
Serum creatinine	mg/dL (milligrams per deciliter)	one day, six months and one year after delivery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Kim S, Lim HJ, Kim JR, Oh KJ, Hong JS, Suh JW. Longitudinal change in arterial stiffness after delivery in women with preeclampsia and normotension: a prospective cohort study. BMC Pregnancy Childbirth. 2020 Nov 11;20(1):685. doi: 10.1186/s12884-020-03374-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 26, 2019
• First Posted (ACTUAL): October 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 26, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Blood pressure; Aortic stiffness; LDL-cholesterol; Preelampsia; Cardio-ankle vascular index (CAVI)
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: B-1402-240-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No