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

Cardiovascular Diseases Clinical Trial

— CVD_OBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406998
• Other study ID #: CVD_OBS
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Samsung Medical Center
• Contact: Ki Hong Choi
• Phone: 82-2-3410-3419
• Email: cardiokh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5461222
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Pregnancy Complications

Intervention

Other:
• Pre-existing atherosclerotic cardiovascular disease
Presence of pre-existing atherosclerotic cardiovascular disease

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of post-partum MACCE	major adverse cardiac and cerebrovascular event	up to 5 years
Secondary	Occurence of All-cause death	Death from any causes	up to 5 years
Secondary	Occurence of myocardial infarction	Myocarrdial infarction	up to 5 years
Secondary	Occurence of revascularization	percutaneous coronary intervention or coronary artery bypass grafting	up to 5 years
Secondary	Occurence of stroke	Ischemic or hemorrhagic stroke	up to 5 years
Secondary	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
Secondary	Occurence of major congenital malformation in offspring	congenital malformation in offspring	At delivery
Secondary	Occurence of neonatal adverse events in offspring	transient tachypnea, respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia, and sepsis	within 30 days
Secondary	Occurence of adverse infant events in offspring	admission to intensive care unit and occurrence of seizure events	Within 1 year
Secondary	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