Cardiovascular DiseasesCVD_OBSNCT06406998
Maternal and Offspring Outcomes in Pregnant Women With Pre-existing ASCVD
An observational study of Cardiovascular Diseases and Atherosclerosis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
A growing body of evidence supports associations between cardiovascular health and adverse pregnancy outcome and between adverse pregnancy outcome and atherosclerotic cardiovascular disease and builds on the well-established pathways known to exist between cardiovascular health and atherosclerotic cardiovascular… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cardiovascular Diseases, Atherosclerosis, Pregnancy Complications
- What is being tested?
- Pre-existing atherosclerotic cardiovascular disease
- How many people
- 5,461,222 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2021to 31 Dec 2024
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: All womens with live birth from Korea
Who may be able to join
- Women with live birth from Korea (between January 1, 2005 to December 31, 2019)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Ki Hong Choi, MD, 82-2-3410-3419, cardiokh@gmail.com
About this study
Official title: Maternal and Offspring Outcomes in Pregnant Women With Pre-existing Atherosclerotic Cardiovascular Disease: A Nationwide Mother-Child Cohort Study
A growing body of evidence supports associations between cardiovascular health and adverse pregnancy outcome and between adverse pregnancy outcome and atherosclerotic cardiovascular disease and builds on the well-established pathways known to exist between cardiovascular health and atherosclerotic cardiovascular disease across the life course and intergenerationally. Furthermore, previous studies frequently lack comprehensive long-term follow-up, making it difficult to assess the enduring impacts of maternal cardiovascular health on postpartum outcomes and long-term maternal and child health.
Read the detailed description
the current study aimed to evaluate the associations between maternal pre-existent atherosclerotic cardiovascular disease and adverse pregnancy outcomes, and the combined effect of maternal pre-existent atherosclerotic cardiovascular disease and adverse pregnancy outcomes on the risk of long-term adverse events of offspring.
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Pregnancy Complications, Adverse Cardiac Event, Adverse Birth Outcomes
- Being tested
- Pre-existing atherosclerotic cardiovascular disease
- Keywords
- Atherosclerotic cardiovascular disease, Major adverse cardiac and cerebrovascular event, Adverse pregnancy outcome, Adverse birth outcomes
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-existing atherosclerotic cardiovascular diseaseOther
Presence of pre-existing atherosclerotic cardiovascular disease
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with pre-existing atherosclerotic cardiovascular disease | Among the total cohort, pregnant women with pre-existing atherosclerotic cardiovascular disease were selected (N=145,315). Receives: Other: Pre-existing atherosclerotic cardiovascular disease | |
| Matched cohort | Among the total cohort, 1:4 matched offspring born to women without pre-existent atherosclerotic cardiovascular disease using a propensity score were generated (N=581,260). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of post-partum MACCE
major adverse cardiac and cerebrovascular event
Measured: up to 5 years
Secondary outcomes (9)
Occurence of All-cause death
Death from any causes
Measured: up to 5 years
Occurence of myocardial infarction
Myocarrdial infarction
Measured: up to 5 years
Occurence of revascularization
percutaneous coronary intervention or coronary artery bypass grafting
Measured: up to 5 years
Occurence of stroke
Ischemic or hemorrhagic stroke
Measured: up to 5 years
Occurence of adverse pregnancy outcome
preterm delivery, pre-eclampsia or eclampsia, other hypertensive disorder of pregnancy, small-for-gestational-age, and gestational diabetes
Measured: At delivery
Occurence of major congenital malformation in offspring
congenital malformation in offspring
Measured: At delivery
Occurence of neonatal adverse events in offspring
transient tachypnea, respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia, and sepsis
Measured: within 30 days
Occurence of adverse infant events in offspring
admission to intensive care unit and occurrence of seizure events
Measured: Within 1 year
Occurence of neurodevelopmental disorders
autism spectrum disorder, attention-deficit/hyperactivity syndrome, cerebral palsy, any developmental delay including motor or cognitive delay, epileptic and febrile seizures and tics, and stereotypic behavior
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jan 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,461,222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
- Investigators
- Ki Hong Choi, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406998
- Sponsor's protocol ID
- CVD_OBS
- Acronym
- CVD_OBS
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kang D, Heo J, Choi KH, Park T, Sung JH, Park TK, Lee JM, Cho J, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Oh SY. Association of maternal pre-existing atherosclerotic cardiovascular disease and neonatal and long-term offspring outcomes: a nationwide mother-child paired cohort. Hum Reprod Open. 2025 Nov 25;2025(4):hoaf074. doi: 10.1093/hropen/hoaf074. eCollection 2025.
PubMed 41383953
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Offspring Outcomes in Pregnant Women With Pre-existing Atherosclerotic Cardiovascular Disease: A Nationwide Mother-Child Cohort Study
- ClinicalTrials.gov ID
- NCT06406998
- Acronym / sponsor ID
- CVD_OBS / CVD_OBS
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Pregnancy Complications, Adverse Cardiac Event, Adverse Birth Outcomes
- Keywords
- Atherosclerotic cardiovascular disease, Major adverse cardiac and cerebrovascular event, Adverse pregnancy outcome, Adverse birth outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,461,222 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 May 2024 (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.
A growing body of evidence supports associations between cardiovascular health and adverse pregnancy outcome and between adverse pregnancy outcome and atherosclerotic cardiovascular disease and builds on the well-established pathways known to exist between cardiovascular health and atherosclerotic cardiovascular disease across the life course and intergenerationally. Furthermore, previous studies frequently lack comprehensive long-term follow-up, making it difficult to assess the enduring impacts of maternal cardiovascular health on postpartum outcomes and long-term maternal and child health.
Detailed description
the current study aimed to evaluate the associations between maternal pre-existent atherosclerotic cardiovascular disease and adverse pregnancy outcomes, and the combined effect of maternal pre-existent atherosclerotic cardiovascular disease and adverse pregnancy outcomes on the risk of long-term adverse events of offspring.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with pre-existing atherosclerotic cardiovascular disease | – | Other: Pre-existing atherosclerotic cardiovascular diseaseAmong the total cohort, pregnant women with pre-existing atherosclerotic cardiovascular disease were selected (N=145,315). |
| Matched cohort | – | –Among the total cohort, 1:4 matched offspring born to women without pre-existent atherosclerotic cardiovascular disease using a propensity score were generated (N=581,260). |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All womens with live birth from Korea
Key inclusion criteria (1 listed)
- Women with live birth from Korea (between January 1, 2005 to December 31, 2019)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-existing atherosclerotic cardiovascular diseasePresence of pre-existing atherosclerotic cardiovascular disease | Other | Pregnant women with pre-existing atherosclerotic cardiovascular disease |
Primary outcome
Occurence of post-partum MACCE
Time frame: up to 5 years
major adverse cardiac and cerebrovascular event
9 secondary outcomes
Occurence of All-cause death
Time frame: up to 5 years
Occurence of myocardial infarction
Time frame: up to 5 years
Occurence of revascularization
Time frame: up to 5 years
Occurence of stroke
Time frame: up to 5 years
Occurence of adverse pregnancy outcome
Time frame: At delivery
Occurence of major congenital malformation in offspring
Time frame: At delivery
Occurence of neonatal adverse events in offspring
Time frame: within 30 days
Occurence of adverse infant events in offspring
Time frame: Within 1 year
Occurence of neurodevelopmental disorders
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 41383953Kang D, Heo J, Choi KH, Park T, Sung JH, Park TK, Lee JM, Cho J, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Oh SY. Association of maternal pre-existing atherosclerotic cardiovascular disease and neonatal and long-term offspring outcomes: a nationwide mother-child paired cohort. Hum Reprod Open. 2025 Nov 25;2025(4):hoaf074. doi: 10.1093/hropen/hoaf074. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ki Hong Choi, MD principal investigator
Samsung Medical Center
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 Cardiovascular Diseases and Atherosclerosis, run by Samsung Medical Center 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 1 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ki Hong Choi (82-2-3410-3419, cardiokh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of post-partum MACCE (time frame: up to 5 years). 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 NCT06406998, 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 9 May 2024.