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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Cardiovascular Health During Pregnancy With Perinatal Outcomes---a Birth Cohort Study
- ClinicalTrials.gov ID
- NCT05776082
- Acronym / sponsor ID
- IRB-20230053-R
- Conditions
- Pregnant Women
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This project intends to recruit pregnant women who go to the research center for routine prenatal examination and give birth.
Key inclusion criteria (4 listed)
- Maternal age: 20-49 years;
- Natural conception;
- Single pregnancy;
- Plan to have routine prenatal examinations and give birth in the research center;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire survey and specimen collectionQuestionnaire survey, clinical follow-up and specimens collection. | Other | – |
Primary outcome
Maternal outcomes
Time frame: 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.
Neonatal outcomes
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, China
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women, run by Women's Hospital School Of Medicine Zhejiang University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal outcomes (time frame: Through delivery completion, up to 42 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.