Maternal Serum Stathmin-1 Levels in Preeclampsia

NCT06481683 | Terminated

• 1 other identifier: Stathmin_2022.08.275
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.What are the maternal serum Stathmin-1 levels in pregnancies with preeclampsia?
2. 2.How do Stathmin-1 levels differ between preeclampsia with severe features and uncomplicated pregnancies?

Conditions

Preeclampsia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maternal Serum Stathmin-1 Levels

  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.

  Measured at the time of diagnosis and followed up until delivery.

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Burak Yücel Special Clinic: lead

Study Sites (1)

Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 1, 2024
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 15, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)