Pre-EclampsiaNCT06623942
Prostasin Levels in Preeclamptic Women
An observational study of Pre-Eclampsia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will aim to compare maternal serum prostasin levels between women diagnosed with preeclampsia and healthy normotensive pregnant controls. Participants will be divided into two main groups: those with preeclampsia and those with uncomplicated pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Mar 2024
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The groups in this study will be selected consists of pregnant women receiving care at a referral center for maternal care.
Who may be able to join
- Diagnosis of Preeclampsia: Defined by new-onset hypertension (systolic Blood Pressure ≥140 mmHg and/or diastolic Blood Pressure ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
- Control Group: Healthy pregnancies without preeclampsia or other significant maternal or fetal complications.
Who cannot join
- Multiple Pregnancies
- Pregestational Diabetes
- Chronic Hypertension
- Systemic Diseases (Chronic kidney disease, autoimmune diseases)
- Fetal Anomalies
- Premature Rupture of Membranes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostasin Levels in Preeclampsia: A Comparative Study With Healthy Pregnancies
This study will aim to compare maternal serum prostasin levels between women diagnosed with preeclampsia and healthy normotensive pregnant controls. Participants will be divided into two main groups: those with preeclampsia and those with uncomplicated pregnancies. The preeclampsia group will further be subdivided based on the severity of the condition. Maternal serum samples will be collected from all participants, and prostasin levels will be measured using ELISA. Statistical analyses will be performed to evaluate whether prostasin levels are significantly elevated in the preeclampsia group, particularly in those with severe features, and to assess its potential as a biomarker for the condition.
- Conditions
- Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia
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 |
|---|---|---|
| Group 1 (Control) | This group consists of uncomplicated pregnancies (who do not have pre-eclampsia or severe pre-eclampsia). These participants will be matched to the case group based on relevant characteristics such as age, gestational age, and other demographic factors. | |
| Group 2 (Case - Pre-eclampsia) | This group consists of pregnant women diagnosed with pre-eclampsia and severe preeclampsia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Serum Prostasin Levels
To compare Prostasin Levels between the pre-eclampsia and the control group.
Measured: Up to 8 weeks (Patients will be followed from inclusion in the study until the end of their pregnancy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
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.
- 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gökhan Bolluk, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623942
- Sponsor's protocol ID
- ProstasinStudy
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 2 Oct 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostasin Levels in Preeclampsia: A Comparative Study With Healthy Pregnancies
- ClinicalTrials.gov ID
- NCT06623942
- Acronym / sponsor ID
- ProstasinStudy
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 2 Oct 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.
This study will aim to compare maternal serum prostasin levels between women diagnosed with preeclampsia and healthy normotensive pregnant controls. Participants will be divided into two main groups: those with preeclampsia and those with uncomplicated pregnancies. The preeclampsia group will further be subdivided based on the severity of the condition. Maternal serum samples will be collected from all participants, and prostasin levels will be measured using ELISA. Statistical analyses will be performed to evaluate whether prostasin levels are significantly elevated in the preeclampsia group, particularly in those with severe features, and to assess its potential as a biomarker for the condition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control) | – | –This group consists of uncomplicated pregnancies (who do not have pre-eclampsia or severe pre-eclampsia). These participants will be matched to the case group based on relevant characteristics such as age, gestational age, and other demographic factors. |
| Group 2 (Case - Pre-eclampsia) | – | –This group consists of pregnant women diagnosed with pre-eclampsia and severe preeclampsia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The groups in this study will be selected consists of pregnant women receiving care at a referral center for maternal care.
Key inclusion criteria (2 listed)
- Diagnosis of Preeclampsia: Defined by new-onset hypertension (systolic Blood Pressure ≥140 mmHg and/or diastolic Blood Pressure ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
- Control Group: Healthy pregnancies without preeclampsia or other significant maternal or fetal complications.
Key exclusion criteria (6 listed)
- Multiple Pregnancies
- Pregestational Diabetes
- Chronic Hypertension
- Systemic Diseases (Chronic kidney disease, autoimmune diseases)
- Fetal Anomalies
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
Maternal Serum Prostasin Levels
Time frame: Up to 8 weeks (Patients will be followed from inclusion in the study until the end of their pregnancy.
To compare Prostasin Levels between the pre-eclampsia and the control group.
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 2 Oct 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 Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 6 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 2 Oct 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 Turkey (Türkiye). 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?
Maternal Serum Prostasin Levels (time frame: Up to 8 weeks (Patients will be followed from inclusion in the study until the end of their pregnancy.). 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 2 Oct 2024.