PreeclampsiaMSSLPNCT06481683
Maternal Serum Stathmin-1 Levels in Preeclampsia
An observational study of Preeclampsia, run by Burak Yücel Special Clinic at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate maternal serum Stathmin-1 levels in pregnancies affected by preeclampsia compared to healthy gestations. The main questions it aims to answer are: 1. What are the maternal serum Stathmin-1 levels in pregnancies with preeclampsia? 2. 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
- Preeclampsia
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 Aug 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The population from which the groups or cohorts in this study will be selected likely consists of pregnant women receiving care at a referral center for maternal care.
Who may be able to join
- Gestational Age: Pregnancies between 20 weeks and term (up to 40 weeks).
- Diagnosis of Preeclampsia (PE): New-onset hypertension (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
- Diagnosis of Severe Preeclampsia: Defined by criteria such as severe hypertension (systolic BP ≥160 mmHg or diastolic BP ≥110 mmHg), organ dysfunction (renal insufficiency, liver involvement, neurological complications), thrombocytopenia, pulmonary edema, or fetal growth restriction.
- Control Group: Healthy pregnancies without preeclampsia or other significant maternal or fetal complications.
Who cannot join
- Multiple Pregnancies: Participants carrying more than one fetus.
- Pregestational Diabetes: Pre-existing diabetes mellitus diagnosed before pregnancy.
- Chronic Hypertension: Pre-existing hypertension diagnosed before pregnancy or before 20 weeks of gestation.
- Systemic Diseases: Chronic kidney disease, autoimmune diseases, or other significant systemic illnesses.
- Fetal Anomalies: Identified structural or genetic abnormalities in the fetus.
- Premature Rupture of Membranes: Spontaneous rupture of membranes before the onset of labor at term (37 weeks of gestation) or preterm (before 37 weeks of gestation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Maternal Serum Stathmin-1 Levels as a Biomarker in Preeclampsia and Severe Preeclampsia
The goal of this observational study is to investigate maternal serum Stathmin-1 levels in pregnancies affected by preeclampsia compared to healthy gestations.
The main questions it aims to answer are:
Read more
- What are the maternal serum Stathmin-1 levels in pregnancies with preeclampsia?
- How do Stathmin-1 levels differ between preeclampsia with severe features and uncomplicated pregnancies?
Researchers will compare Stathmin-1 levels in pregnancies with preeclampsia and preeclampsia with severe features to those in a control group of healthy pregnancies to assess differences in biomarker levels.
Participants will undergo blood sample collection at 32-34 weeks of gestation. Have their blood samples processed for Stathmin-1 level measurement using ELISA.
- Conditions
- Preeclampsia
- Keywords
- Stathmin-1, Preeclampsia, Severe Preeclampsia, Trophoblast invasion, Maternal serum biomarkers
- 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 |
|---|---|---|
| Pre-eclampsia Group (Case Group) | This group consists of pregnant women diagnosed with pre-eclampsia. These participants will have specific characteristics related to the pre-eclampsia condition, such as elevated blood pressure and proteinuria. | |
| Severe Pre-eclampsia Group (Case Group) | This group consists of pregnant women diagnosed with severe pre-eclampsia. These participants will have more severe symptoms and complications related to pre-eclampsia, potentially including higher blood pressure, significant proteinuria, and other related health issues. | |
| Control Group | This group consists of pregnant women who do not have pre-eclampsia or severe pre-eclampsia. These participants will be matched to the case groups based on relevant characteristics such as age, gestational age, and other demographic factors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Serum Stathmin-1 Levels
To identify and compare Maternal Serum Stathmin-1 Levels levels between the pre-eclampsia group, severe pre-eclampsia group, and the control group. This will help in understanding the biochemical environment associated with pre-eclampsia and its severity.
Measured: Measured at the time of diagnosis and followed up until delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jan 2023
- Primary completion1 Jul 2023
- Study completion15 Aug 2023
Why it stopped: The study was terminated due to the change of the clinic where the principal investigator was employed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burak Yücel Special Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Yücel, Burak Yücel Special Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481683
- Sponsor's protocol ID
- Stathmin_2022.08.275
- Acronym
- MSSLP
- Status last verified
- Sep 2024
- First submitted
- 24 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maternal Serum Stathmin-1 Levels as a Biomarker in Preeclampsia and Severe Preeclampsia
- ClinicalTrials.gov ID
- NCT06481683
- Acronym / sponsor ID
- MSSLP / Stathmin_2022.08.275
- Conditions
- Preeclampsia
- Keywords
- Stathmin-1, Preeclampsia, Severe Preeclampsia, Trophoblast invasion, Maternal serum biomarkers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated due to the change of the clinic where the principal investigator was employed.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Burak Yücel Special ClinicUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 1 Jul 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.
The goal of this observational study is to investigate maternal serum Stathmin-1 levels in pregnancies affected by preeclampsia compared to healthy gestations.
The main questions it aims to answer are:
- What are the maternal serum Stathmin-1 levels in pregnancies with preeclampsia?
- How do Stathmin-1 levels differ between preeclampsia with severe features and uncomplicated pregnancies?
Researchers will compare Stathmin-1 levels in pregnancies with preeclampsia and preeclampsia with severe features to those in a control group of healthy pregnancies to assess differences in biomarker levels.
Participants will undergo blood sample collection at 32-34 weeks of gestation. Have their blood samples processed for Stathmin-1 level measurement using ELISA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-eclampsia Group (Case Group) | – | –This group consists of pregnant women diagnosed with pre-eclampsia. These participants will have specific characteristics related to the pre-eclampsia condition, such as elevated blood pressure and proteinuria. |
| Severe Pre-eclampsia Group (Case Group) | – | –This group consists of pregnant women diagnosed with severe pre-eclampsia. These participants will have more severe symptoms and complications related to pre-eclampsia, potentially including higher blood pressure, significant proteinuria, and other related health issues. |
| Control Group | – | –This group consists of pregnant women who do not have pre-eclampsia or severe pre-eclampsia. These participants will be matched to the case groups based on relevant characteristics such as age, gestational age, and other demographic factors. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population from which the groups or cohorts in this study will be selected likely consists of pregnant women receiving care at a referral center for maternal care.
Key inclusion criteria (4 listed)
- Gestational Age: Pregnancies between 20 weeks and term (up to 40 weeks).
- Diagnosis of Preeclampsia (PE): New-onset hypertension (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
- Diagnosis of Severe Preeclampsia: Defined by criteria such as severe hypertension (systolic BP ≥160 mmHg or diastolic BP ≥110 mmHg), organ dysfunction (renal insufficiency, liver involvement, neurological complications), thrombocytopenia, pulmonary edema, or fetal growth restriction.
- Control Group: Healthy pregnancies without preeclampsia or other significant maternal or fetal complications.
Key exclusion criteria (6 listed)
- Multiple Pregnancies: Participants carrying more than one fetus.
- Pregestational Diabetes: Pre-existing diabetes mellitus diagnosed before pregnancy.
- Chronic Hypertension: Pre-existing hypertension diagnosed before pregnancy or before 20 weeks of gestation.
- Systemic Diseases: Chronic kidney disease, autoimmune diseases, or other significant systemic illnesses.
- Fetal Anomalies: Identified structural or genetic abnormalities in the fetus.
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 Stathmin-1 Levels
Time frame: Measured at the time of diagnosis and followed up until delivery.
To identify and compare Maternal Serum Stathmin-1 Levels levels between the pre-eclampsia group, severe pre-eclampsia group, and the control group. This will help in understanding the biochemical environment associated with pre-eclampsia and its severity.
Results and safety
The study was stopped early (reason given: The study was terminated due to the change of the clinic where the principal investigator was employed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
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 Preeclampsia, run by Burak Yücel Special Clinic 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 4 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: stopped early, as of the sponsor's last update on 19 Sep 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 was stopped early (reason given: The study was terminated due to the change of the clinic where the principal investigator was employed.). 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?
Maternal Serum Stathmin-1 Levels (time frame: Measured at the time of diagnosis and followed up until delivery.). 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 19 Sep 2024.