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NCT03891394 Clinical Trial

Human Epididymis Protein 4 in Women With Severe Preeclampsia / HELLP Syndrome

Preeclampsia Clinical Trial

Official title:
Prognostic Value of Human Epididymis Protein 4 (HE4) for Persistent Proteinuria in Women With Severe Preeclampsia / HELLP Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03891394
Other study ID # ainshamHE4
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date October 30, 2019

Study information
Verified date March 2019
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pre-eclampsia seems to be associated with a four to five times increase risk of later microalbuminuria and CKD which might suggest a possible direct renal damage from pre-eclampsia

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 110
Est. completion date October 30, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

1. Pregnant women 18-35 years old.

2. Fulfilling the criteria for diagnosis of sever preeclampsia.

3. Fulfilling the criteria for diagnosis of HELLP syndrome

Exclusion Criteria:

1. Diabetes mellitus

2. Preexisting renal disease.

3. Chronic hypertension

4. Rheumatologic diseases

5. Adnexal mass.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Human epididymis protein 4
Human epididymis protein 4 serum level in predicting persistent proteniuria

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary protein in urine proteinuria > 0.3 mg protein / mg creatinine. 12 weeks postpartum
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