- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03200743
Catestatin and Hypertension in Pregnancy
June 26, 2017 updated by: Yuchen Pan
Relationship Between Catestatin and Pregnant Hypertensive Disorders
Catestatin is a kind of protein involved with cardiovascular disease.
Accumulated evidence shows that Catestatin may be a predictor of primary hypertension, but whether it plays the same role in pregnant hypertensive disorders needs to be determined.
By measuring the plasma level of Catestatin, main biochemical marks and UCG in healthy pregnancy and pregnancy with hypertension, the research may contribute to this problem.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijin, Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
Contact:
- Yuchen Pan, MD
- Phone Number: +8618810533382
- Email: panyuchen@bjmu.edu.cn
-
Contact:
- Dan Zhu, MD
- Email: andrea_zhu@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients hospitalized in Peking University Third Hospital maternity ward after May, 2017
Description
Inclusion Criteria:
- Healthy pregnancy women
Pregnancy women with hypertension
- Despite the pregnant gestational age , systolic blood pressure ≥140 mm Hg OR a diastolic blood pressure of ≥90 mm Hg measured three times more than 24 hours apart
- Pregnant gestational age > 20 weeks, systolic blood pressure ≥140 mm Hg OR a diastolic blood pressure of ≥90 mm Hg measured twice more than 4 hours apart
Exclusion Criteria:
- Lack of blood sample at the specified enrollment period
- Women who refuse the study
- Other illness which needs medications interfering with blood pressure (eg: Asthma requiring systemic steroids)
- Known coronary artery disease or heart failure
- Serious medical illness (eg: renal insufficiency, congestive heart disease, chronic respiratory insufficiency, uncontrolled infection).
- multiple endocrine neoplasia or Cushing's syndrome or mixed tumours or pheochromocytoma or medullary thyroid carcinoma.
- previous history of malignant tumour, with the exception of carcinoma in situ of the uterine cervix or non-melanoma skin cancer
- renal insufficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Hpertension
|
|
Health
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
plasma level of Catestatin
Time Frame: once at the specified enrollment period
|
plasma level of Catestatin with the unit "mmol/l"
|
once at the specified enrollment period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood pressure
Time Frame: the specified enrollment period,42 days and 2 months after the pregnancy
|
systolic and diastolic blood pressure with the unit "mmHg"
|
the specified enrollment period,42 days and 2 months after the pregnancy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2017
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
June 19, 2017
First Submitted That Met QC Criteria
June 26, 2017
First Posted (Actual)
June 27, 2017
Study Record Updates
Last Update Posted (Actual)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 26, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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