Maternal Serum Stathmin-1 Levels in Preeclampsia

NCT ID: NCT06623955

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-03-01

Brief Summary

This study investigates maternal serum Stathmin-1 (STMN-1) levels in pregnancies complicated by preeclampsia and severe preeclampsia, compared to healthy pregnancies. The aim is to explore potential differences in STMN-1 levels among these groups to better understand its role in preeclampsia pathophysiology. Maternal serum STMN-1 levels will be measured between 32-34 weeks of gestation, and patients will be monitored until delivery to assess whether they develop preeclampsia or severe preeclampsia.

Conditions

Pre-Eclampsia

Study Design

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

Study Groups

Group 1 (Control)

This group consists of pregnant women who do not have pre-eclampsia or severe pre-eclampsia. These participants will be matched to the case group based on relevant characteristics such as age, gestational age, and other demographic factors.

No interventions assigned to this group

Group 2 (Case - Pre-eclampsia)

This group consists of pregnant women diagnosed with pre-eclampsia and severe preeclampsia.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Preeclampsia: Defined by New-onset hypertension (Systolic Blood Pressure ≥140 mmHg and/or Diastolic Blood Pressure ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
• Clinical 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

Exclusion Criteria

• Multiple Pregnancies
• Pregestational Diabetes
• Chronic Hypertension
• Systemic Diseases (Chronic kidney disease, autoimmune diseases)
• Fetal Anomalies
• Premature Rupture of Membranes

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

Sponsors

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gökhan Bolluk

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Stathmin-1Study

Identifier Type: -

Identifier Source: org_study_id