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Maternal and Offspring Outcomes in Pregnant Women With Pre-existing ASCVD

Maternal and Offspring Outcomes in Pregnant Women With Pre-existing Atherosclerotic Cardiovascular Disease: A Nationwide Mother-Child Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06406998
Acronym
CVD_OBS
Enrollment
5461222
Registered
2024-05-09
Start date
2021-01-01
Completion date
2024-12-31
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Birth Outcomes, Adverse Cardiac Event, Atherosclerosis, Cardiovascular Diseases, Pregnancy Complications

Keywords

Atherosclerotic cardiovascular disease, Major adverse cardiac and cerebrovascular event, Adverse pregnancy outcome, Adverse birth outcomes

Brief 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 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.

Interventions

OTHERPre-existing atherosclerotic cardiovascular disease

Presence of pre-existing atherosclerotic cardiovascular disease

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE

Inclusion criteria

* Women with live birth from Korea (between January 1, 2005 to December 31, 2019)

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Occurence of post-partum MACCEup to 5 yearsmajor adverse cardiac and cerebrovascular event

Secondary

MeasureTime frameDescription
Occurence of myocardial infarctionup to 5 yearsMyocarrdial infarction
Occurence of revascularizationup to 5 yearspercutaneous coronary intervention or coronary artery bypass grafting
Occurence of strokeup to 5 yearsIschemic or hemorrhagic stroke
Occurence of adverse pregnancy outcomeAt deliverypreterm delivery, pre-eclampsia or eclampsia, other hypertensive disorder of pregnancy, small-for-gestational-age, and gestational diabetes
Occurence of All-cause deathup to 5 yearsDeath from any causes
Occurence of neonatal adverse events in offspringwithin 30 daystransient tachypnea, respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia, and sepsis
Occurence of adverse infant events in offspringWithin 1 yearadmission to intensive care unit and occurrence of seizure events
Occurence of neurodevelopmental disordersup to 5 yearsautism 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
Occurence of major congenital malformation in offspringAt deliverycongenital malformation in offspring

Countries

South Korea

Contacts

Primary ContactKi Hong Choi
cardiokh@gmail.com82-2-3410-3419
Backup ContactDanbee Kang, PhD
dbee.kang@skku.edu82-2-2148-7197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026