Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03217916
Study type Observational
Source Woman's Health University Hospital, Egypt
Contact
Status Not yet recruiting
Phase N/A
Start date August 1, 2017
Completion date March 1, 2018

See also
  Status Clinical Trial Phase
Completed NCT03613714 - Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy N/A
Completed NCT02338687 - Low Dose Calcium to Prevent Preeclampsia Phase 4
Completed NCT04752475 - Lasix for the Prevention of De Novo Postpartum Hypertension Phase 3
Completed NCT03334149 - Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension N/A
Recruiting NCT03298802 - Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide Phase 3
Completed NCT03076619 - A Clinical Study of Fundus Findings in Toxaemia of Pregnancy N/A
Recruiting NCT05473767 - Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children N/A
Completed NCT03356106 - Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy N/A
Recruiting NCT05849103 - Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy N/A
Recruiting NCT03200743 - Catestatin and Hypertension in Pregnancy N/A
Terminated NCT04343235 - Postpartum Management of Gestational Hypertensive Disorders Using Furosemide Phase 4
Completed NCT01508208 - Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders N/A
Active, not recruiting NCT04580927 - Breastfeeding and Postpartum Cardiovascular Health N/A
Recruiting NCT03858595 - Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy N/A
Recruiting NCT05655936 - Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial N/A
Completed NCT02523781 - Evaluation of an Information Pamphlet for Postpartum Women That Had a Hypertensive Pregnancy N/A
Completed NCT01736826 - Free DNA and Nucleosome Concentrations in Pathological Pregnancies
Completed NCT03556761 - Furosemide for Accelerated Recovery of Blood Pressure Postpartum Phase 2
Completed NCT00949260 - Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-Invasive Bio-Reactance N/A
Active, not recruiting NCT04012151 - Arm and Finger Measurement for Blood Pressure Surveillance