Hypertension, Pregnancy-InducedNCT03217916
Kidney Injury Biomarkers in Preeclampsia
An observational study of Hypertension, Pregnancy-Induced, run by Woman's Health University Hospital, Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hypertension, Pregnancy-Induced
- What is being tested?
- Elisa assay of podocyte glycoprotein in urine
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women attending at the Emergency room of Assiut university Hospital \&Luxor International Hospital
Who may be able to join
- the presence of informed consent
- Prim gravid or multi gravid <5
- age:18-35 ys
- Singleton pregnancy with gestational age >34weeks
Who cannot join
- Serious maternal illness.
- Smokers
- women with pregnancy complicated by nephritic syndrome, diabetic mellitus, or gestational diabetes
- women known to have renal disease
- oliguria
About this study
Official title: Evaluation of Kidney Injury Biomarkers in Women Suffering From Preeclampsia
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.
Read the 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:
- Detailed history taking
- Clinical examination:
- General examination: pulse, temperature, blood pressure, body weight and height, body mass index.
- Abdominal examination.
- obestetric Ultrasonography to calculate gestational age,viability , amniotic fluid ,placental site and to exclude any congenital malformation.
- Assessemet of renal function :urine output,blood urea,serum creatinine, u/s
- All routine investigations: C.B.C., Rh, blood grouping, kidney functions tests, liver enzymes.
- 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.
- 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
- Conditions
- Hypertension, Pregnancy-Induced
- Being tested
- Elisa assay of podocyte glycoprotein in urine
- Keywords
- podocyte glycoprotein, kidney injury, preeclampsia
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| normotensive groups | pregnant women with normal blood pressure Receives: Diagnostic Test: Elisa assay of podocyte glycoprotein in urine | |
| hypertensive groups | pregnant women with severe preclampsia Receives: Diagnostic Test: Elisa assay of podocyte glycoprotein in urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of renal injury caused by preclampsia
the changes in renal chemistry (serum creatinine and blood urea) in pregnant women with severe preclampsia
Measured: within 6 month postpartum
Secondary outcomes (1)
Apgar score of the deliverd fetus
standard score to assess fetal status after delivery
Measured: 1, 5 and 10 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Feb 2018 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Pregnancy-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Luxor International Hospital
- Responsible party
- Principal investigator, Hisham Ahmed El-Sayed Abou-Taleb, Woman's Health University Hospital, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217916
- Sponsor's protocol ID
- gemy
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26671966Sibai 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.
PubMed 15733721Karumanchi 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.
PubMed 17403396
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Kidney Injury Biomarkers in Women Suffering From Preeclampsia
- ClinicalTrials.gov ID
- NCT03217916
- Acronym / sponsor ID
- gemy
- Conditions
- Hypertension, Pregnancy-Induced
- Keywords
- podocyte glycoprotein, kidney injury, preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Collaborators
- Luxor International Hospital
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Feb 2018 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Detailed history taking
- Clinical examination:
- General examination: pulse, temperature, blood pressure, body weight and height, body mass index.
- Abdominal examination.
- obestetric Ultrasonography to calculate gestational age,viability , amniotic fluid ,placental site and to exclude any congenital malformation.
- Assessemet of renal function :urine output,blood urea,serum creatinine, u/s
- All routine investigations: C.B.C., Rh, blood grouping, kidney functions tests, liver enzymes.
- 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.
- 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normotensive groups | – | Diagnostic Test: Elisa assay of podocyte glycoprotein in urinepregnant women with normal blood pressure |
| hypertensive groups | – | Diagnostic Test: Elisa assay of podocyte glycoprotein in urinepregnant women with severe preclampsia |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women attending at the Emergency room of Assiut university Hospital \&Luxor International Hospital
Key inclusion criteria (4 listed)
- the presence of informed consent
- Prim gravid or multi gravid <5
- age:18-35 ys
- Singleton pregnancy with gestational age >34weeks
Key exclusion criteria (5 listed)
- Serious maternal illness.
- Smokers
- women with pregnancy complicated by nephritic syndrome, diabetic mellitus, or gestational diabetes
- women known to have renal disease
- oliguria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elisa assay of podocyte glycoprotein in urineBiomarkers 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. | Diagnostic test | hypertensive groups, normotensive groups |
Primary outcome
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
1 secondary outcome
Apgar score of the deliverd fetus
Time frame: 1, 5 and 10 minutes after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Background: PubMed 26671966Wang 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.
- Background: PubMed 15733721Sibai 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.
- Background: PubMed 17403396Karumanchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pregnancy-Induced, run by Woman's Health University Hospital, Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of renal injury caused by preclampsia (time frame: within 6 month postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03217916, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.