Association of Gestational Cardiovascular Health With Pregnancy Outcomes

NCT05776082 | Recruiting

• 1 other identifier: IRB-20230053-R
• Study Type: observational
• Target: 5,000
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Questionnaire survey and specimen collection OTHER

Questionnaire survey, clinical follow-up and specimens collection.

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

Taizhou First People's Hospital

Taizhou, Zhejiang, 310000, China

RECRUITING

Rwanda Society of Obstetricians and Gynecologists

Kigali, Rwanda

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, saliva, placenta and umbilical cord blood from pregnant women will be collected for testing

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 20, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-04

Locations

RW (1); CN (2)