Human Epididymis Protein 4 in Women With Severe Preeclampsia / HELLP Syndrome
Prognostic Value of Human Epididymis Protein 4 (HE4) for Persistent Proteinuria in Women With Severe Preeclampsia / HELLP Syndrome
1 other identifier
observational
110
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedMarch 28, 2019
March 1, 2019
6 months
March 25, 2019
March 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
protein in urine
proteinuria \> 0.3 mg protein / mg creatinine.
12 weeks postpartum
Interventions
Human epididymis protein 4 serum level in predicting persistent proteniuria
Eligibility Criteria
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
You may qualify if:
- Pregnant women 18-35 years old.
- Fulfilling the criteria for diagnosis of sever preeclampsia.
- Fulfilling the criteria for diagnosis of HELLP syndrome
You may not qualify if:
- Diabetes mellitus
- Preexisting renal disease.
- Chronic hypertension
- Rheumatologic diseases
- Adnexal mass.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
March 25, 2019
First Posted
March 27, 2019
Study Start
April 1, 2019
Primary Completion
October 1, 2019
Study Completion
October 30, 2019
Last Updated
March 28, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share