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

Recruiting

• Conditions: Atherosclerosis; Pregnancy Complications; Adverse Cardiac Event; Cardiovascular Diseases; Adverse Birth Outcomes
• Interventions: Other: Pre-existing atherosclerotic cardiovascular disease

• Registration Number: NCT06406998
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 5461222

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women with pre-existing atherosclerotic cardiovascular disease	Pre-existing atherosclerotic cardiovascular disease	Among the total cohort, pregnant women with pre-existing atherosclerotic cardiovascular disease were selected (N=145,315).

Primary Outcome Measures

Name	Time	Method
Occurence of post-partum MACCE	up to 5 years	major adverse cardiac and cerebrovascular event

Secondary Outcome Measures

Name	Time	Method
Occurence of All-cause death	up to 5 years	Death from any causes
Occurence of revascularization	up to 5 years	percutaneous coronary intervention or coronary artery bypass grafting
Occurence of stroke	up to 5 years	Ischemic or hemorrhagic stroke
Occurence of neonatal adverse events in offspring	within 30 days	transient tachypnea, respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia, and sepsis
Occurence of adverse infant events in offspring	Within 1 year	admission to intensive care unit and occurrence of seizure events
Occurence of myocardial infarction	up to 5 years	Myocarrdial infarction
Occurence of adverse pregnancy outcome	At delivery	preterm delivery, pre-eclampsia or eclampsia, other hypertensive disorder of pregnancy, small-for-gestational-age, and gestational diabetes
Occurence of major congenital malformation in offspring	At delivery	congenital malformation in offspring
Occurence of neurodevelopmental disorders	up to 5 years	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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of