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Association of Gestational Cardiovascular Health With Pregnancy Outcomes

Sponsor
Women's Hospital School Of Medicine Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05776082
Collaborator
(none)
5,000
Enrollment
1
Location
34
Anticipated Duration (Months)
146.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire survey and specimen collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Association of Cardiovascular Health During Pregnancy With Perinatal Outcomes---a Birth Cohort Study
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. Maternal outcomes [Through delivery completion, up to 42 weeks]

    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.

  2. Neonatal outcomes [Through delivery completion, up to 42 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 49 Years
Sexes Eligible for Study:
Female
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women's Hospital School Of Medicine Zhejiang University Hangzhou Zhejiang China 310006

Sponsors and Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier:
NCT05776082
Other Study ID Numbers:
  • IRB-20230053-R
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 20, 2023