Preeclampsia and EclampsiaNCT04142268
Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic Women After Delivery
An observational study of Preeclampsia and Eclampsia and Stiffness, Aortic, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia and Eclampsia, Stiffness, Aortic, Blood Pressure
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to May 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Women who were hemodynamically compromised or had bleeding complication after delivery were excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463707
About this study
Official title: 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.
Read the 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.
- Keywords
- Preelampsia, Cardio-ankle vascular index (CAVI), Aortic stiffness, Blood pressure, LDL-cholesterol
- Medical subject headings
- Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The CAVI was measured at one day, six months and one year after delivery in both groups.
Secondary outcomes (7)
Systolic blood pressure
automated blood pressure, mmHg
Measured: one day, six months and one year after delivery
Diastolic blood pressure
automated blood pressure, mmHg
Measured: one day, six months and one year after delivery
Body weight
kilograms
Measured: 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
Measured: one day, six months and one year after delivery
Lipid profiles (Total cholesterol, TG, LDL, HDL)
mg/dL (milligrams per deciliter)
Measured: one day, six months and one year after delivery
AST(aspartate aminotransferase), ALT(alanine aminotransferase)
IU/L (International Units Per Litre)
Measured: one day, six months and one year after delivery
Serum creatinine
mg/dL (milligrams per deciliter)
Measured: one day, six months and one year after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study startMar 2013
- Primary completionOct 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preeclampsia and EclampsiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Jung-Won Suh, Seoul National University Hospital
- Investigators
- Jung-Won Suh, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142268
- Sponsor's protocol ID
- B-1402-240-006
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2019
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33176736
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic and Normotensive Women After Delivery: One-Year Follow-Up Results
- ClinicalTrials.gov ID
- NCT04142268
- Acronym / sponsor ID
- B-1402-240-006
- Keywords
- Preelampsia, Cardio-ankle vascular index (CAVI), Aortic stiffness, Blood pressure, LDL-cholesterol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Mar 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who were hemodynamically compromised or had bleeding complication after delivery were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Systolic blood pressure
Time frame: one day, six months and one year after delivery
Diastolic blood pressure
Time frame: one day, six months and one year after delivery
Body weight
Time frame: one day, six months and one year after delivery
Waist/Hip ratio
Time frame: one day, six months and one year after delivery
Lipid profiles (Total cholesterol, TG, LDL, HDL)
Time frame: one day, six months and one year after delivery
AST(aspartate aminotransferase), ALT(alanine aminotransferase)
Time frame: one day, six months and one year after delivery
Serum creatinine
Time frame: one day, six months and one year after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Results publication: PubMed 33176736Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Won Suh, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Eclampsia and Stiffness, Aortic, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.