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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03891394
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 28, 2019
Information provided by (Responsible Party):
Radwa Rasheedy Ali, Ain Shams University

Brief 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

Condition or disease Intervention/treatment
Preeclampsia Diagnostic Test: Human epididymis protein 4

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Human Epididymis Protein 4 (HE4) for Persistent Proteinuria in Women With Severe Preeclampsia / HELLP Syndrome
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. protein in urine [ Time Frame: 12 weeks postpartum ]
    proteinuria > 0.3 mg protein / mg creatinine.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population

The diagnosis is made after 20 weeks of gestation in previously normotensive women who develop:

  • Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg and proteinuria (with or without signs and symptoms of significant end-organ dysfunction).
  • Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg (with or without proteinuria) and one or more of the following signs and symptoms of significant end-organ dysfunction

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.
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Responsible Party: Radwa Rasheedy Ali, principal investigator, Ain Shams University Identifier: NCT03891394    
Other Study ID Numbers: ainshamHE4
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HELLP Syndrome
Hypertension, Pregnancy-Induced
Pregnancy Complications