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Trial record 25 of 148 for:    severe preeclampsia AND hypertensive disorders

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
Sponsor:
Collaborator:
Luxor International Hospital
Information provided by (Responsible Party):
Hisham Ahmed El-Sayed Abou-Taleb, Woman's Health University Hospital, Egypt

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.

Condition or disease Intervention/treatment
Hypertension, Pregnancy-Induced Diagnostic Test: Elisa assay of podocyte glycoprotein in urine

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Detailed Description:

Study design:

  • Type of the study: Aprospective cross sectional study .All patients will be enrolled in the study after obtaining a written consent.
  • Setting: This study will be carried in the Emergency room of Assiut university Hospital &Luxor International Hospital

Statistical Methods:

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
  • Methods :

    200 patients with severe peclampsia will be recorded in Assiut university hospital and luxor international hospital in aperiod of 6 months initial assessement: Blood pressure will be measuerd in ER urine analysis will be done in ER by Urine Dipstick Analysis 40 cases will be randomized selected where urine sample will be collected to analyze the markers to be studied

The women will be subjected to the following:

  1. Detailed history taking
  2. Clinical examination:

    1. General examination: pulse, temperature, blood pressure, body weight and height, body mass index.
    2. Abdominal examination.
  3. obestetric Ultrasonography to calculate gestational age,viability , amniotic fluid ,placental site and to exclude any congenital malformation.
  4. Assessemet of renal function :urine output,blood urea,serum creatinine, u/s
  5. All routine investigations: C.B.C., Rh, blood grouping, kidney functions tests, liver enzymes.
  6. sample collection : Freshly obtained urine specimens were centrifuged at 1,500 rpm for 10 min within 30 min of collection, aliquoted, and stored at _70°C until assayed. Dipstick detection for urine protein, pH, and gravity. Urine protein, pH, gravity, etc. were detected by Dipstick (Uri-Trak-3) in all urine specimens before being aliquoted for storage at _70°C. Urine protein was positive for all study subjects in mild and severe preeclamptic groups.

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.

6. postnatal visits: Postnatal investigation, monitoring and treatment (including after discharge from critical care) Blood pressure

Weekly till the end of puerperium.the postatal visits will iclude:

  • Measurement of blood pressure
  • U/S kidney
  • Askig about urinary symptoms as amout of urine ,colour of urine ,and burning sensation.

Postnatal care will be done according to NICE clinical guidelines at the nearby patients health care centre .the patients will be handed on information sheet containing instructions about postnatal care. the patients will be followed up by telephone to report any abnormalities that may occur


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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
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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
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


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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
Study Population
pregnant women attending at the Emergency room of Assiut university Hospital &Luxor International Hospital
Criteria

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:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hisham Ahmed El-Sayed Abou-Taleb, Woman's Health University Hospital, Egypt:
podocyte glycoprotein
kidney injury
preeclampsia
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
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