Maternal Serum Stathmin-1 Levels in Preeclampsia

Completed

• Conditions: Preeclampsia

• Registration Number: NCT06481683
• Lead Sponsor: Burak Yücel Special Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-15
• Status Verified: 2024-06
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-30
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal Serum Stathmin-1 Levels	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.

Trial Locations

Locations (1)

Cam and Sakura City Hospital; 🇹🇷 Istanbul, Turkey