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PreeclampsiaNCT03615560

China Obstetrics Alliance Cohort Study

An observational study of Preeclampsia, run by Guangzhou Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Preeclampsia (PE) is one of a common type of hypertensive disorder complicating pregnancy (HDCP). It is a class of clinical syndromes which shows relevant symptoms, hypertension and proteinuria after 20 weeks pregnant as main characteristic, and may accompany with fetal anomaly and systemic multi-system organs damage. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Preeclampsia
How many people
1,000 participants
Where
No sites listed yet
Study dates
1 Jan 2017to 1 Jan 2022
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: staff in The Third Affiliated Hospital of Guangzhou Medical Universit

Who may be able to join

  • Choose subjects that have ever got PE before as the experimental group. Pair the same age, gestational weeks, children's gender and healthy subject as a control group in the ratio of 1:1.

Who cannot join

  • The control group should exclude subject that have ever got heart or lung diseases, diabetes, chronic nephrosis, immune disease and other hereditary disease.

About this study

Official title: The Study of Prevention and Intervention Strategy of Gestational Diseases Based on Cohort

Preeclampsia (PE) is one of a common type of hypertensive disorder complicating pregnancy (HDCP). It is a class of clinical syndromes which shows relevant symptoms, hypertension and proteinuria after 20 weeks pregnant as main characteristic, and may accompany with fetal anomaly and systemic multi-system organs damage. Several complications, such as eclamptic seizures, coma, intracranial hemorrhage (ICH), cardiac failure, pneumonedema, hepatic failure, kidney failure, placental abruption and disseminated intravascular coagulation (DIC), may be threat to the life of the mother as well as fetal. Thus, the disease is one of the core issues that cause the maternal and perinatal death. Morbidity of PE is approximately 3% to 5%. Morbidity has significant differences between different populations. According to the data, from 1995 to 2004, HDCP morbidity in four hospitals in Guangzhou was 5.78%, and in the HDCP, mild preeclampsia and severe preeclampsia were accounted for 72.22% and 27.78% respectively. Meanwhile, HDCP morbidity decreased from 9.4% (1984 to 1989) to 5.57% (1989 to 1998).

In 1996, the American Congress of Obstetricians and Gynecologists (ACOG) gave new classification of HDCP based on the characteristic of disease symptoms, divide into five groups; gestational hypertension, preeclampsia, eclampsia, chronic hypertension complicated with preeclampsia and chronic hypertension. The pathogenesis of PE remains unclear so far. The frequent sight is that PE caused by multiple reactions by a number of factors affect. Physiologically, mainly altered of PE is increased blood viscosity and systemic vascular spasm which cause hypoxic-ischemic of multiple key organs, such as the placenta, kidney, liver and brain. The research theory includes abnormal trophoblast invasion, immune response abnormal or increase, genetic susceptibility, coagulation disorders or thrombophilia, abnormal angiogenesis, endothelial cell damage, abnormal levels of carbonic oxide, increase of oxygen radical, abnormal metabolism of calcium ion, heterotrophia and so on. However, there are numbers of epidemiologic study have analyzed high risk factor of PE which provides significant medical evidence of prevention, early diagnosis and early treatment for PE, there is only little study focus on susceptibility gene and pathogenic genetic variation. Nowadays, there are numerous clinical phenotype are considered to exist, different phenotype gives different inheritance and epigenetics. Thus, the investigator's group will examine the onset of type and characteristics of PE by a retrospective cohort study to discuss if susceptibility gene and pathogenic genetic variation were existing in PE patients, also to find the relativity between clinical phenotype and genotype. Moreover, this study is trying to reach the effect of PE on the patients' health as well as their children. Thus, can predict the health status of PE patients and their children, and so can prevent (avoid or delay) of the patients from late complications and disease in their children.

Read the detailed description
  1. All female staff that works, examination and delivery in the Third Affiliated Hospital of Guangzhou Medical University from Dec 1995 to Dec 2016 should be in the cohort. Collect all information; include clinical examination and medical examination, science the subject work in the hospital. Collect the perinatal data; include obstetric information, past medical history, family history and so on. Build the database and analyze the relative factor.
  2. From all subjects, choose subjects that have got PE before as the experimental group. Pair the same age, gestational weeks, children's gender and healthy subject as a control group in the ratio of 1:1. The control group should exclude subject that have ever got heart or lung diseases, diabetes, chronic nephrosis, immune disease and other hereditary disease. Store the blood samples (serum, blood and plasma) of both the experimental group and control group and their children. Compare the differences of functional parameter between two groups both before and after delivery, which include blood pressure, blood glucose and blood lipids. Moreover, compare the function of heart, liver and kidney and genetic material (DNA and RNA).
  3. Diagnostic standard of PE refer to People's Medical Publishing House <Obstetrics and Gynecology> 8th edition. Confirm the diagnostic standard of HDCP and relative disease include PE will make sure the veracity and uniformity of diagnosis.
Conditions
Preeclampsia
Keywords
Medical staff, preeclampsia, cohort study, further effect
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03615560
Study groupRoleWhat they receive
Preeclampsia (mild)Not described
Preeclampsia (severe)Not described
Gestational hypertensionNot described
Control groupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sample collection

    Collect the record of the medical staff through the personnel office, confirm the subject

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start1 Jan 2017
  3. Primary completion1 Jan 2019
  4. Study completion1 Jan 2022 (estimated)

Resources

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
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615560
Sponsor's protocol ID
2016YFC1000405
Status last verified
Jun 2019
First submitted
31 Jul 2018
Last updated
7 Jun 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Preeclampsia, run by Guangzhou Medical University.

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 1 inclusion and 1 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 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sample collection (time frame: 1 year). 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 7 Jun 2019.

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