Association of Gestational Cardiovascular Health With Pregnancy Outcomes

Pregnant Women Clinical Trial

Official title:

Association of Cardiovascular Health During Pregnancy With Perinatal Outcomes---a Birth Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776082
• Other study ID #: IRB-20230053-R
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pregnancy is a critical period for cardiovascular health risk assessment and interventions to reduce the incidence of cardiovascular disease in both mother and child generations. Recently, the American Heart Association proposed the latest cardiovascular health assessment indicator "Life's Essential 8". However, there is still a lack of application data for pregnant women. This project intends to explore the application potential of Life's Essential 8 in cardiovascular health assessment of pregnant women and establish appropriate gestaional cardiovascular health standards.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

Inclusion Criteria:

• Maternal age: 20-49 years;
• Natural conception;
• Single pregnancy;
• Plan to have routine prenatal examinations and give birth in the research center;

Exclusion Criteria:

• Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy;
• Assisted reproduction;
• Multiple pregnancy;
• Fetus has a known deformity or genetic defects;
• Incomplete clinical data.

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Other:
• Questionnaire survey and specimen collection
Questionnaire survey, clinical follow-up and specimens collection.

Locations

Country	Name	City	State
China	Women's Hospital School Of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal outcomes	Including pregnancy-induced hypertension, preterm delivery, abortion, delivery way and so on. They are diagnosed by clinicians and the data is gathered from medical records.	Through delivery completion, up to 42 weeks
Primary	Neonatal outcomes	Birth weight(in gram), birth height (in centimetre), gestational week (in week) and other neonatal diseases. They are diagnosed by clinicians and the data is gathered from medical records.	Through delivery completion, up to 42 weeks