Maternal Serum Stathmin-1 Levels in Preeclampsia

Evaluation of Maternal Serum Stathmin-1 Levels as a Biomarker in Preeclampsia and Severe Preeclampsia

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06481683

Acronym

MSSLP

Enrollment

Registered

2024-07-01

Start date

2023-01-01

Completion date

2023-08-15

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Stathmin-1, Preeclampsia, Severe Preeclampsia, Trophoblast invasion, Maternal serum biomarkers

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Outcome results