Maternal Serum Stathmin-1 Levels in Preeclampsia

NCT06623955 | Completed

• 1 other identifier: Stathmin-1Study
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Maternal Serum Stathmin-1

  To compare Stathmin-1 Levels between the pre-eclampsia and the control group.

  Up to 8 weeks (Patients will be followed from inclusion in the study until the end of their pregnancy.)

Study Arms (2)

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.

Group 2 (Case - Pre-eclampsia)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The groups in this study will be selected consists of pregnant women receiving care at a referral center for maternal care.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Cam and Sakura City Hospital

Istanbul, 34480, 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 GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

TU (1)