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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

Tracking Information
First Submitted Date July 11, 2017
First Posted Date July 14, 2017
Last Update Posted Date July 14, 2017
Estimated Study Start Date August 1, 2017
Estimated Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2017)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 13, 2017)
Apgar score of the deliverd fetus [ Time Frame: 1, 5 and 10 minutes after delivery ]
standard score to assess fetal status after delivery
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Kidney Injury Biomarkers in Preeclampsia
Official Title Evaluation of Kidney Injury Biomarkers in Women Suffering From Preeclampsia
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.
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

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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
Sampling Method Non-Probability Sample
Study Population pregnant women attending at the Emergency room of Assiut university Hospital &Luxor International Hospital
Condition Hypertension, Pregnancy-Induced
Intervention 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.

Study Groups/Cohorts
  • normotensive groups
    pregnant women with normal blood pressure
    Intervention: Diagnostic Test: Elisa assay of podocyte glycoprotein in urine
  • hypertensive groups
    pregnant women with severe preclampsia
    Intervention: Diagnostic Test: Elisa assay of podocyte glycoprotein in urine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 13, 2017)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2018
Estimated Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03217916
Other Study ID Numbers gemy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hisham Ahmed El-Sayed Abou-Taleb, Woman's Health University Hospital, Egypt
Study Sponsor Woman's Health University Hospital, Egypt
Collaborators Luxor International Hospital
Investigators Not Provided
PRS Account Woman's Health University Hospital, Egypt
Verification Date July 2017