Association of Gestational Cardiovascular Health With Pregnancy Outcomes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women
• Intervention / Treatment: Other: Questionnaire survey and specimen collection

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Women's Hospital School Of Medicine Zhejiang University
      • Contact: Zhaoxia Liang, Prof.; Phone Number: 86571-89992115; Email: xiaozaizai@zju.edu.cn
    • Taizhou, Zhejiang, China, 310000
      • Recruiting
      • Taizhou First People's Hospital
      • Contact: Yu Han; Phone Number: 86576-84016905; Email: 428102@zju.edu.cn
• Rwanda
  • Kigali, Rwanda
    • Active, not recruiting
    • Rwanda Society of Obstetricians and Gynecologists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

This project intends to recruit pregnant women who go to the research center for routine prenatal examination and give birth.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID Numbers: IRB-20230053-R

Drug and device information, study documents

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