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Completed

NCT Number: NCT04142268

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

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.

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Key information

Conditions

Preeclampsia and Eclampsia Blood Pressure Eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Stiffness, Aortic Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Case group : Women who were diagnosed preeclampsia based on the criteria of the International Society for the Study of Hypertension in Pregnancy
  • 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.

Treatment and study plan

Primary outcomes

  1. The differences in longitudinal change pattern of CAVI between preeclampsia and normal pregnant women.

    Time frame: 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 outcomes

  1. Systolic blood pressure

    Time frame: one day, six months and one year after delivery

    automated blood pressure, mmHg

  2. Diastolic blood pressure

    Time frame: one day, six months and one year after delivery

    automated blood pressure, mmHg

  3. Body weight

    Time frame: one day, six months and one year after delivery

    kilograms

  4. Waist/Hip ratio

    Time frame: 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

  5. Lipid profiles (Total cholesterol, TG, LDL, HDL)

    Time frame: one day, six months and one year after delivery

    mg/dL (milligrams per deciliter)

  6. AST(aspartate aminotransferase), ALT(alanine aminotransferase)

    Time frame: one day, six months and one year after delivery

    IU/L (International Units Per Litre)

  7. Serum creatinine

    Time frame: one day, six months and one year after delivery

    mg/dL (milligrams per deciliter)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 29, 2019
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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