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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Atherosclerosis; Pregnancy Complications; Adverse Cardiac Event; Adverse Birth Outcomes
• Intervention / Treatment: Other: Pre-existing atherosclerotic cardiovascular disease

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 Type: Observational
• Enrollment (Estimated): 5461222

Contacts and Locations

• Study Contact: Name: Ki Hong Choi; Phone Number: 82-2-3410-3419; Email: cardiokh@gmail.com
• Study Contact Backup: Name: Danbee Kang, PhD; Phone Number: 82-2-2148-7197; Email: dbee.kang@skku.edu

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Ki Hong Choi, MD; Phone Number: 82-2-3410-3419; Email: cardiokh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All womens with live birth from Korea

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Presence of 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of post-partum MACCE	major adverse cardiac and cerebrovascular event	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of All-cause death	Death from any causes	up to 5 years
Occurence of myocardial infarction	Myocarrdial infarction	up to 5 years
Occurence of revascularization	percutaneous coronary intervention or coronary artery bypass grafting	up to 5 years
Occurence of stroke	Ischemic or hemorrhagic stroke	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	At delivery
Occurence of major congenital malformation in offspring	congenital malformation in offspring	At delivery
Occurence of neonatal adverse events in offspring	transient tachypnea, respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia, and sepsis	within 30 days
Occurence of adverse infant events in offspring	admission to intensive care unit and occurrence of seizure events	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	up to 5 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Ki Hong Choi, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 4, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Atherosclerotic cardiovascular disease; Adverse pregnancy outcome; Major adverse cardiac and cerebrovascular event; Adverse birth outcomes
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiovascular Diseases; Atherosclerosis; Pregnancy Complications
• Other Study ID Numbers: CVD_OBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No