Maternal Serum Stathmin-1 Levels in Preeclampsia (MSSLP)

Burak Yücel Special Clinic

Status: Terminated

Conditions: Preeclampsia

Study type: Observational

Funder types: Other

Identifiers

NCT06481683

Stathmin_2022.08.275

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

80 participants in 3 patient groups

Pre-eclampsia Group (Case Group)

Description:

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)

Description:

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

Description:

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.