Pre-EclampsiaNCT06214702
Serpin C and Soluble Fms-like Tyrosine Kinase-1 Levels in Normotensive Pregnant Women May Predict the Development of Preeclampsia
An observational study of Pre-Eclampsia, run by Benha University at 1 site in Egypt.
Trial summary
Evaluation of the predictability of estimated levels of Serpin C, sFlt-1 and placental growth factor (PLGF) in blood samples obtained during the 1st trimester from normotensive pregnant women for identification of women liable to develop PE during the course of pregnancy. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- ELISA
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2023to 15 Nov 2023
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients were having monthly follow-up of pregnancy and determination of BP measures, and estimation of the serum levels of the studied biomarkers. Patients who developed GHTN at the 20th GW were grouped as GHTN group and those who were normotensive at the 20th GW were considered as control.
Who may be able to join
- Normotensive pregnant women had singleton fetus presenting during the 1st trimester
- free of exclusion criteria
Who cannot join
- Age
- Sex
- Hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deregulated Serum Levels of Serpin C and Soluble Fms-like Tyrosine Kinase-1 Might Predict the Development of Preeclampsia in Normotensive Pregnant Women
Evaluation of the predictability of estimated levels of Serpin C, sFlt-1 and placental growth factor (PLGF) in blood samples obtained during the 1st trimester from normotensive pregnant women for identification of women liable to develop PE during the course of pregnancy.
- Conditions
- Pre-Eclampsia
- Being tested
- ELISA
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADiagnostic test
ELISA estimation of PLGF, sFlt-1 and Serpin C
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with diastolic blood pressure (DBP) after the 20th GW up ≥140 or 90 mmHg without proteinuria. Receives: Diagnostic Test: ELISA | |
| Control Group | Patients were normotensive at the 20th GW. Receives: Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of Biomarkers in detection of GHTN
The predictability of serum biomarkers' levels estimated at enrolment for the development of GHTN.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start7 Jan 2023
- Primary completion12 May 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Benha 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar K. Naser, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214702
- Sponsor's protocol ID
- RC 7.1.2024
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deregulated Serum Levels of Serpin C and Soluble Fms-like Tyrosine Kinase-1 Might Predict the Development of Preeclampsia in Normotensive Pregnant Women
- ClinicalTrials.gov ID
- NCT06214702
- Acronym / sponsor ID
- RC 7.1.2024
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 22 Jan 2024 (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.
Evaluation of the predictability of estimated levels of Serpin C, sFlt-1 and placental growth factor (PLGF) in blood samples obtained during the 1st trimester from normotensive pregnant women for identification of women liable to develop PE during the course of pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: ELISAPatients with diastolic blood pressure (DBP) after the 20th GW up ≥140 or 90 mmHg without proteinuria. |
| Control Group | – | Diagnostic Test: ELISAPatients were normotensive at the 20th GW. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients were having monthly follow-up of pregnancy and determination of BP measures, and estimation of the serum levels of the studied biomarkers. Patients who developed GHTN at the 20th GW were grouped as GHTN group and those who were normotensive at the 20th GW were considered as control.
Key inclusion criteria (2 listed)
- Normotensive pregnant women had singleton fetus presenting during the 1st trimester
- free of exclusion criteria
Key exclusion criteria (3 listed)
- Age
- Sex
- Hypertension
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 |
|---|---|---|
| ELISAELISA estimation of PLGF, sFlt-1 and Serpin C | Diagnostic test | Control Group, Study group |
Primary outcome
Role of Biomarkers in detection of GHTN
Time frame: 9 months
The predictability of serum biomarkers' levels estimated at enrolment for the development of GHTN.
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 22 Jan 2024.
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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.
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 Pre-Eclampsia, run by Benha 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 22 Jan 2024. 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?
Role of Biomarkers in detection of GHTN (time frame: 9 months). 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 22 Jan 2024.