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Clinical Trials/NCT06406998
NCT06406998
Recruiting
Not Applicable

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

Samsung Medical Center1 site in 1 country5,461,222 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Samsung Medical Center
Enrollment
5461222
Locations
1
Primary Endpoint
Occurence of post-partum MACCE
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ki Hong Choi

Associate Professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Occurence of post-partum MACCE

Time Frame: up to 5 years

major adverse cardiac and cerebrovascular event

Secondary Outcomes

  • Occurence of All-cause death(up to 5 years)
  • Occurence of revascularization(up to 5 years)
  • Occurence of stroke(up to 5 years)
  • Occurence of neonatal adverse events in offspring(within 30 days)
  • Occurence of adverse infant events in offspring(Within 1 year)
  • Occurence of myocardial infarction(up to 5 years)
  • Occurence of adverse pregnancy outcome(At delivery)
  • Occurence of major congenital malformation in offspring(At delivery)
  • Occurence of neurodevelopmental disorders(up to 5 years)

Study Sites (1)

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