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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03200743
Other study ID # 20170513
Secondary ID
Status Recruiting
Phase N/A
First received June 19, 2017
Last updated June 26, 2017
Start date May 14, 2017
Est. completion date December 2017

Study information

Verified date June 2017
Source Peking University Third Hospital
Contact Yuchen Pan, MD
Phone +8618810533382
Email panyuchen@bjmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Locations

Country Name City State
China Peking University Third Hospital Beijin Beijing

Sponsors (1)

Lead Sponsor Collaborator
Yuchen Pan

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary plasma level of Catestatin plasma level of Catestatin with the unit "mmol/l" once at the specified enrollment period
Secondary blood pressure systolic and diastolic blood pressure with the unit "mmHg" the specified enrollment period,42 days and 2 months after the pregnancy
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