Kidney Injury Biomarkers in Preeclampsia
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ClinicalTrials.gov Identifier: NCT03217916 |
Recruitment Status : Unknown
Verified July 2017 by Hisham Ahmed El-Sayed Abou-Taleb, Woman's Health University Hospital, Egypt.
Recruitment status was: Not yet recruiting
First Posted : July 14, 2017
Last Update Posted : July 14, 2017
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Condition or disease | Intervention/treatment |
---|---|
Hypertension, Pregnancy-Induced | Diagnostic Test: Elisa assay of podocyte glycoprotein in urine |

Study Type : | Observational |
Estimated Enrollment : | 40 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Evaluation of Kidney Injury Biomarkers in Women Suffering From Preeclampsia |
Estimated Study Start Date : | August 1, 2017 |
Estimated Primary Completion Date : | February 1, 2018 |
Estimated Study Completion Date : | March 1, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
normotensive groups
pregnant women with normal blood pressure
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Diagnostic Test: Elisa assay of podocyte glycoprotein in urine
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 groups
pregnant women with severe preclampsia
|
Diagnostic Test: Elisa assay of podocyte glycoprotein in urine
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. |
- Magnitude of renal injury caused by preclampsia [ Time Frame: within 6 month postpartum ]the changes in renal chemistry (serum creatinine and blood urea) in pregnant women with severe preclampsia
- Apgar score of the deliverd fetus [ Time Frame: 1, 5 and 10 minutes after delivery ]standard score to assess fetal status after delivery
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- the presence of informed consent
- Prim gravid or multi gravid <5
- age:18-35 ys
- Singleton pregnancy with gestational age >34weeks
Exclusion Criteria:
- Serious maternal illness.
- Smokers
- women with pregnancy complicated by nephritic syndrome, diabetic mellitus, or gestational diabetes
- women known to have renal disease
- oliguria
Publications:
Responsible Party: | Hisham Ahmed El-Sayed Abou-Taleb, Hisham A. Abou-Taleb, Woman's Health University Hospital, Egypt |
ClinicalTrials.gov Identifier: | NCT03217916 History of Changes |
Other Study ID Numbers: |
gemy |
First Posted: | July 14, 2017 Key Record Dates |
Last Update Posted: | July 14, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
podocyte glycoprotein kidney injury preeclampsia |
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Hypertension Vascular Diseases Cardiovascular Diseases polysaccharide-K Adjuvants, Immunologic Immunologic Factors |
Physiological Effects of Drugs Antibiotics, Antineoplastic Antineoplastic Agents Antiviral Agents Anti-Infective Agents Interferon Inducers Radiation-Protective Agents Protective Agents |