Clinical trial NCT04142268: Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic Women After Delivery
Official title: Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic and Normotensive Women After Delivery: One-Year Follow-Up Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia and Eclampsia
Stiffness, Aortic
Blood Pressure
Keywords: Preelampsia
Cardio-ankle vascular index (CAVI)
Aortic stiffness
Blood pressure
LDL-cholesterol
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2019-10-29
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The differences in longitudinal change pattern of CAVI between preeclampsia and normal pregnant women.
timeFrame: The CAVI was measured at one day, six months and one year after delivery in both groups.
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: one day, six months and one year after delivery
measure: Diastolic blood pressure
timeFrame: one day, six months and one year after delivery
measure: Body weight
timeFrame: one day, six months and one year after delivery
measure: Waist/Hip ratio
timeFrame: one day, six months and one year after delivery
measure: Lipid profiles (Total cholesterol, TG, LDL, HDL)
timeFrame: one day, six months and one year after delivery
measure: AST(aspartate aminotransferase), ALT(alanine aminotransferase)
timeFrame: one day, six months and one year after delivery
measure: Serum creatinine
timeFrame: one day, six months and one year after delivery
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung-Won Suh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.