Clinical trial NCT06481683: Maternal Serum Stathmin-1 Levels in Preeclampsia
Official title: Evaluation of Maternal Serum Stathmin-1 Levels as a Biomarker in Preeclampsia and Severe Preeclampsia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Preeclampsia
Keywords: Stathmin-1
Preeclampsia
Severe Preeclampsia
Trophoblast invasion
Maternal serum biomarkers
Lead sponsor: Burak Yücel Special Clinic
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Maternal Serum Stathmin-1 Levels
timeFrame: Measured at the time of diagnosis and followed up until delivery.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cam and Sakura City Hospital
Study officials:
References: