Maternal Serum Stathmin-1 Levels in Preeclampsia (MSSLP)

September 11, 2024 updated by: Burak Yücel, Burak Yücel Special Clinic

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

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

This study aimed to understand how levels of a protein called Stathmin-1 in the blood of pregnant women might be related to preeclampsia, a serious condition that can occur during pregnancy. Preeclampsia involves high blood pressure and can lead to complications for both the mother and baby. By examining Stathmin-1 levels, researchers hoped to find new ways to detect and understand this condition better.

Women eligible for participation include those with preeclampsia, including severe cases, and healthy pregnant women. Exclusions apply to women with multiple pregnancies, diabetes, chronic hypertension, systemic diseases, fetal anomalies, or premature membrane rupture.

The study will commence with obtaining written consent from participants. Blood samples will be collected during 32-34 weeks of gestation and processed in the lab for Stathmin-1 level measurement using ELISA. Comparative analysis of Stathmin-1 levels among participant groups aims to enhance understanding and management of preeclampsia.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Çam and Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Serum Stathmin-1 Levels
Time Frame: 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.
Measured at the time of diagnosis and followed up until delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Burak Yücel Special Clinic

Collaborators

Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stathmin_2022.08.275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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