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

NCT04142268 | Completed

• 1 other identifier: B-1402-240-006
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia and Eclampsia; Stiffness, Aortic; Blood Pressure

Keywords

Preelampsia; Cardio-ankle vascular index (CAVI); Aortic stiffness; Blood pressure; LDL-cholesterol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Systolic blood pressure

  one day, six months and one year after delivery

• Diastolic blood pressure

  one day, six months and one year after delivery

• Body weight

  one day, six months and one year after delivery

• Waist/Hip ratio

  one day, six months and one year after delivery

• Lipid profiles (Total cholesterol, TG, LDL, HDL)

  one day, six months and one year after delivery

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Related Publications (1)

• 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.

  PMID: 33176736 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jung-Won Suh, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 29, 2019
• Study Start: March 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: May 1, 2017
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

KR (1)