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Catestatin and Hypertension in Pregnancy

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ClinicalTrials.gov Identifier: NCT03200743
Recruitment Status : Unknown
Verified June 2017 by Yuchen Pan, Peking University Third Hospital.
Recruitment status was:  Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Yuchen Pan, Peking University Third Hospital

Tracking Information
First Submitted Date June 19, 2017
First Posted Date June 27, 2017
Last Update Posted Date June 27, 2017
Actual Study Start Date May 14, 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2017)
plasma level of Catestatin [ Time Frame: once at the specified enrollment period ]
plasma level of Catestatin with the unit "mmol/l"
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 26, 2017)
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"
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Catestatin and Hypertension in Pregnancy
Official Title Relationship Between Catestatin and Pregnant Hypertensive Disorders
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 18 Years
Biospecimen Retention:   None Retained
Description:
Plasma
Sampling Method Probability Sample
Study Population Patients hospitalized in Peking University Third Hospital maternity ward after May, 2017
Condition
  • Pre-Eclampsia
  • Eclampsia
  • Hypertension, Pregnancy-Induced
  • Hypertension in Pregnancy
Intervention Not Provided
Study Groups/Cohorts
  • Hpertension
  • Health
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 26, 2017)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Healthy pregnancy women
  • Pregnancy women with hypertension

    1. 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
    2. 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03200743
Other Study ID Numbers 20170513
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Yuchen Pan, Peking University Third Hospital
Study Sponsor Yuchen Pan
Collaborators Not Provided
Investigators Not Provided
PRS Account Peking University Third Hospital
Verification Date June 2017