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Trial record 1 of 44 for:    severe preeclampsia AND proteinuria
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Human Epididymis Protein 4 in Women With Severe Preeclampsia / HELLP Syndrome

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ClinicalTrials.gov Identifier: NCT03891394
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 28, 2019
Sponsor:
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.



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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
Criteria

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
ClinicalTrials.gov Identifier: NCT03891394     History of Changes
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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Pre-Eclampsia
HELLP Syndrome
Hypertension, Pregnancy-Induced
Pregnancy Complications