Maternal Serum Stathmin-1 Levels in Preeclampsia

NCT ID: NCT06481683

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-08-15

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.

Conditions

Preeclampsia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Burak Yücel Special Clinic

OTHER

Sponsor Role: lead

Responsible Party

Burak Yücel

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Stathmin_2022.08.275

Identifier Type: -

Identifier Source: org_study_id