Pregnant WomenNCT05776082
Association of Gestational Cardiovascular Health With Pregnancy Outcomes
An observational study of Pregnant Women, run by Women's Hospital School Of Medicine Zhejiang University at 3 sites in 2 countries.
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". Read more about this study
- Who is it for?
- Ages 20 to 49 years, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Questionnaire survey and specimen collection
- How many people
- 5,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Mar 2023to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- Adult
Study population: This project intends to recruit pregnant women who go to the research center for routine prenatal examination and give birth.
Who may be able to join
- Maternal age: 20-49 years;
- Natural conception;
- Single pregnancy;
- Plan to have routine prenatal examinations and give birth in the research center;
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
China2 sites, 2 recruiting
- Recruiting
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Zhaoxia Liang, Prof., 86571-89992115, xiaozaizai@zju.edu.cn
- Recruiting
Taizhou First People's Hospital
Taizhou, Zhejiang, 310000
Yu Han, 86576-84016905, 428102@zju.edu.cn
Rwanda1 site
- Active, not recruiting
Rwanda Society of Obstetricians and Gynecologists
Kigali
About this study
Official title: 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.
- Conditions
- Pregnant Women
- Being tested
- Questionnaire survey and specimen collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire survey and specimen collectionOther
Questionnaire survey, clinical follow-up and specimens collection.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through delivery completion, up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776082
- Sponsor's protocol ID
- IRB-20230053-R
- Status last verified
- Jun 2026
- First submitted
- 23 Feb 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No