Detection of Preeclampsia ComplicationsPETNCT02665897
Pre-eclampsia and Biochemical Markers
An observational study of Detection of Preeclampsia Complications, run by Assiut University at 1 site in Egypt.
Trial summary
In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney impairment characteristics, a recent study demonstrated that the serum levels of NGAL increased at the end of the second trimester in women who subsequently developed pre-eclampsia compared to the control group. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Detection of Preeclampsia Complications
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to May 2017
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women after 20 weeks
Who may be able to join
- Age 20-40 years.
- Gestational age >20 weeks.
Who cannot join
- Patients with preexisting renal disease,hypertension, diabetes mellitus, gestational hypertension.
- Patients Refuse to participate in the study
- Patients already have complicated preeclampsia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Complications of Pre-eclampsia and Detection of Novel Biochemical Markers
In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney impairment characteristics, a recent study demonstrated that the serum levels of NGAL increased at the end of the second trimester in women who subsequently developed pre-eclampsia compared to the control group.
This correlates well with the endothelial damage that occurs during pre-eclampsia and thus NGAL can be considered as a promising marker in predicting both early and late onset pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the precision, and sensitivity for detection of risk and reliability of using biomarkers for pre-eclampsia.
- Conditions
- Detection of Preeclampsia Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eclampsia | pregnant women with eclampsia will be diagnosed by the occurrence of seizures on top of preeclampsia. | |
| severe preeclampsia | pregnant women with severe preeclampsia will be diagnosed according to blood pressure ≥160/110 mmHg with proteinuria detection by boiling method +3,+4. | |
| healthy | matched normotensive pregnant women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of circulating NGAL
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detection of Preeclampsia ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665897
- Sponsor's protocol ID
- PET
- Acronym
- PET
- Status last verified
- Jun 2017
- First submitted
- 22 Jan 2016
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Complications of Pre-eclampsia and Detection of Novel Biochemical Markers
- ClinicalTrials.gov ID
- NCT02665897
- Acronym / sponsor ID
- PET / PET
- Conditions
- Detection of Preeclampsia Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Jan 2016 (estimated)
- 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.
In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney impairment characteristics, a recent study demonstrated that the serum levels of NGAL increased at the end of the second trimester in women who subsequently developed pre-eclampsia compared to the control group.
This correlates well with the endothelial damage that occurs during pre-eclampsia and thus NGAL can be considered as a promising marker in predicting both early and late onset pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the precision, and sensitivity for detection of risk and reliability of using biomarkers for pre-eclampsia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eclampsia | – | –pregnant women with eclampsia will be diagnosed by the occurrence of seizures on top of preeclampsia. |
| severe preeclampsia | – | –pregnant women with severe preeclampsia will be diagnosed according to blood pressure ≥160/110 mmHg with proteinuria detection by boiling method +3,+4. |
| healthy | – | –matched normotensive pregnant women. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women after 20 weeks
Key inclusion criteria (2 listed)
- Age 20-40 years.
- Gestational age >20 weeks.
Key exclusion criteria (3 listed)
- Patients with preexisting renal disease,hypertension, diabetes mellitus, gestational hypertension.
- Patients Refuse to participate in the study
- Patients already have complicated preeclampsia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The level of circulating NGAL
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Individual participant dataSharing planned: Yes
Related trials for Detection of Preeclampsia Complications
RecruitingObservational study
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE)
Recruiting
Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia
Pulmonary Edema - Acute, Preeclampsia
Recruiting
Identifying Biomarkers for Endothelial Dysfunction in Women With Preeclampsia
Endothelial Function (FMD), Preeclampsia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Detection of Preeclampsia Complications, run by Assiut University at 1 site in 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The level of circulating NGAL (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2017.