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

NCT06406998 | Recruiting

• 1 other identifier: CVD_OBS
• Study Type: observational
• Target: 5,461,222
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Occurence of post-partum MACCE

  major adverse cardiac and cerebrovascular event

  up to 5 years

Secondary Outcomes (9)

• Occurence of All-cause death

  up to 5 years

• Occurence of myocardial infarction

  up to 5 years

• Occurence of revascularization

  up to 5 years

• Occurence of stroke

  up to 5 years

• Occurence of adverse pregnancy outcome

  At delivery

Study Arms (2)

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).

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).

Interventions

Pre-existing atherosclerotic cardiovascular disease OTHER

Presence of pre-existing atherosclerotic cardiovascular disease

Pregnant women with pre-existing atherosclerotic cardiovascular disease

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All womens with live birth from Korea

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 41383953 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis; Pregnancy Complications

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ki Hong Choi, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki Hong Choi

CONTACT

82-2-3410-3419; cardiokh@gmail.com

Danbee Kang, PhD

CONTACT

82-2-2148-7197; dbee.kang@skku.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 9, 2024
• Study Start: January 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

KR (1)