Congenital Heart DiseaseNCT02914392
Study on the Relationship Between Maternal Exposure to Environmental Factors and Fetal Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
The objective of this study is to research the relationship between maternal exposure to environmental factors and fetal congenital heart disease in a community-based case-control study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- 18 May 2017to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Gravidas with singleton pregnancy living in SHANGHAI
Who may be able to join
- Gravida with singleton pregnancy taking fetal echocardiography in 16th-29nd of gestational weeks.
- Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
- On the basis of informed consent，willing to cooperate with our group.
Who cannot join
- Pregnant women with serious pregnancy complications .
- Pregnant women suffering from mental illness, can't take care of themselves. 3) Fetus diagnosed with chromosomal abnormalities in pregnant women .
- 4）Repeated explanation does not cooperate in pregnant women.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Chen Sun, 8621-25078485
Sun Jing
- Active, not recruiting
School of environmental science and engineering, Shanghai jiaotong university
Shanghai
About this study
Official title: Multi-center Clinical Study on the Relationship Between Maternal Exposure to Important Environmental Factors and Fetal Congenital Heart Disease
The objective of this study is to research the relationship between maternal exposure to environmental factors and fetal congenital heart disease in a community-based case-control study.
Read the detailed description
This is a community-based case-control study in SHANGHAI,a municipality in CHINA. Cases will be identified from maternity centers. Matched controls will be accrued from the same region as the case came from. Pregnant cases and their controls are women (18-45 years). Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography in 16th-29nd of gestational weeks. Controls are pregnant women without fetal congenital heart disease diagnosis. Only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. About 2 controls matched by year of birth and region will be allocated to each case. A standardized questionnaire will be used for all cases and controls. Field investigations are also conducted for them by quantitative measurement of some chemical, physical and nutritional factors related indicators may affect fetal cardiovascular development. Study participants will be asked for their informed consent.
- Conditions
- Congenital Heart Disease
- Keywords
- case control study, Environmental Factors, Fetal Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fetal congenital heart disease cases | Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography | |
| Matched Controls for fetal congenital heart disease cases | Gravidas without fetal congenital heart disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Congenital heart disease
Measured: Sep 2016 to Jul 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start18 May 2017
- Primary completionJul 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kun Sun, MD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914392
- Sponsor's protocol ID
- XH-16-023
- Status last verified
- Jan 2018
- First submitted
- 22 Sep 2016
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Study on the Relationship Between Maternal Exposure to Important Environmental Factors and Fetal Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02914392
- Acronym / sponsor ID
- XH-16-023
- Conditions
- Congenital Heart Disease
- Keywords
- case control study, Environmental Factors, Fetal Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- 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.
The objective of this study is to research the relationship between maternal exposure to environmental factors and fetal congenital heart disease in a community-based case-control study.
Detailed description
This is a community-based case-control study in SHANGHAI,a municipality in CHINA. Cases will be identified from maternity centers. Matched controls will be accrued from the same region as the case came from. Pregnant cases and their controls are women (18-45 years). Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography in 16th-29nd of gestational weeks. Controls are pregnant women without fetal congenital heart disease diagnosis. Only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. About 2 controls matched by year of birth and region will be allocated to each case. A standardized questionnaire will be used for all cases and controls. Field investigations are also conducted for them by quantitative measurement of some chemical, physical and nutritional factors related indicators may affect fetal cardiovascular development. Study participants will be asked for their informed consent.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal congenital heart disease cases | – | –Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography |
| Matched Controls for fetal congenital heart disease cases | – | –Gravidas without fetal congenital heart disease |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Gravidas with singleton pregnancy living in SHANGHAI
Key inclusion criteria (3 listed)
- Gravida with singleton pregnancy taking fetal echocardiography in 16th-29nd of gestational weeks.
- Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
- On the basis of informed consent，willing to cooperate with our group.
Key exclusion criteria (3 listed)
- Pregnant women with serious pregnancy complications .
- Pregnant women suffering from mental illness, can't take care of themselves. 3) Fetus diagnosed with chromosomal abnormalities in pregnant women .
- 4）Repeated explanation does not cooperate in pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal Congenital heart disease
Time frame: Sep 2016 to Jul 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Kun Sun, MD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Sun, MD (8621-25078485, chengsun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal Congenital heart disease (time frame: Sep 2016 to Jul 2018). 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 23 Jan 2018.