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

March 27, 2019 updated by: Radwa Rasheedy Ali, Ain Shams University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

N/A

Genders 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
protein in urine
Time Frame: 12 weeks postpartum
proteinuria > 0.3 mg protein / mg creatinine.
12 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 30, 2019

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ainshamHE4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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