Prostasin Levels in Preeclamptic Women

NCT06623942 | Completed

• 1 other identifier: ProstasinStudy
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study will aim to compare maternal serum prostasin levels between women diagnosed with preeclampsia and healthy normotensive pregnant controls. Participants will be divided into two main groups: those with preeclampsia and those with uncomplicated pregnancies. The preeclampsia group will further be subdivided based on the severity of the condition. Maternal serum samples will be collected from all participants, and prostasin levels will be measured using ELISA. Statistical analyses will be performed to evaluate whether prostasin levels are significantly elevated in the preeclampsia group, particularly in those with severe features, and to assess its potential as a biomarker for the condition.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• Maternal Serum Prostasin Levels

  To compare Prostasin 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 uncomplicated pregnancies (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:

• 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.
• Control Group: Healthy pregnancies without preeclampsia or other significant maternal or fetal complications.

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)