NCT03217916

Brief Summary

we found different pattern of podocyte glycoproteins and kidney injury biomarkers in urine specimens between preeclampsia and pregnancy complicated with chronic hypertention compared with normotensive pregnant controls.abnormally elevayed urine biomarkers in severe preeclampsia were completely or prtially reduced 6-8 weaks after delivery to levels comparable with those of normal pregnant subjects.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Status
unknown

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

July 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

July 11, 2017

Last Update Submit

July 13, 2017

Conditions

Hypertension, Pregnancy-Induced

Keywords

podocyte glycoproteinkidney injurypreeclampsia

Outcome Measures

Primary Outcomes (1)

  • Magnitude of renal injury caused by preclampsia

    the changes in renal chemistry (serum creatinine and blood urea) in pregnant women with severe preclampsia

    within 6 month postpartum

Secondary Outcomes (1)

  • Apgar score of the deliverd fetus

    1, 5 and 10 minutes after delivery

Study Arms (2)

normotensive groups

pregnant women with normal blood pressure

Diagnostic Test: Elisa assay of podocyte glycoprotein in urine

hypertensive groups

pregnant women with severe preclampsia

Diagnostic Test: Elisa assay of podocyte glycoprotein in urine

Interventions

Elisa assay of podocyte glycoprotein in urineDIAGNOSTIC_TEST

Biomarkers evaluated in urine specimens including podocyte glycoproteins nephrin and podocalyxin, All biomarkers were measured by ELISA. Assay information for sources of ELISA kits, standard cure range, sample dilution factors, etc. All assays will be performed following the manufacture's instructions. All specimens will be measured in duplicate. Personnel who performed the assays of analyteswere blinded to the clinical information.

hypertensive groupsnormotensive groups

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women attending at the Emergency room of Assiut university Hospital \&Luxor International Hospital

You may qualify if:

  • the presence of informed consent
  • Prim gravid or multi gravid \<5
  • age:18-35 ys
  • Singleton pregnancy with gestational age \>34weeks

You may not qualify if:

  • Serious maternal illness.
  • Smokers
  • women with pregnancy complicated by nephritic syndrome, diabetic mellitus, or gestational diabetes
  • women known to have renal disease
  • oliguria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Wang Y, Gu Y, Loyd S, Jia X, Groome LJ. Increased urinary levels of podocyte glycoproteins, matrix metallopeptidases, inflammatory cytokines, and kidney injury biomarkers in women with preeclampsia. Am J Physiol Renal Physiol. 2015 Dec 15;309(12):F1009-17. doi: 10.1152/ajprenal.00257.2015. Epub 2015 Oct 14.

    PMID: 26671966BACKGROUND

  • Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.

    PMID: 15733721BACKGROUND

  • Karumanchi SA, Lindheimer MD. Preeclampsia and the kidney: footprints in the urine. Am J Obstet Gynecol. 2007 Apr;196(4):287-8. doi: 10.1016/j.ajog.2007.02.013. No abstract available.

    PMID: 17403396BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine sample: 40 ml of a freshly obtained urine specimens will be centrifuged at 1,500 rpm for 10 min within 30 min of collection, aliquoted, and stored at -70°C until assayed

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedPre-Eclampsia

Interventions

Urination

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hisham A. Abou-Taleb

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 14, 2017

Study Start

August 1, 2017

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

July 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share