Analyses of Interleukin-6, Presepsin and Pentraxin-3 in the Diagnosis and Severity of Late-onset Preeclampsia

Completed

• Conditions: Preeclampsia
• Interventions: Other: interleukin-6, presepsin and pentraxin-3

• Registration Number: NCT04126902
• Lead Sponsor: Cengiz Gokcek Women's and Children's Hospital

Brief Summary

Introduction: The etiology/pathophysiology of preeclampsia remains an enigma. Cellular immunity is a key factor in the etiology of late-onset preeclampsia (L-PrE). Presepsin is split out from the phagocytes membranes after phagocytosis. To investigators knowledge, this is the first study in literature to investigate maternal blood concentrations of presepsin in preeclampsia and healthy pregnant women.

Methods: The investigators examined maternal plasma interleukin-6, presepsin and pentraxin-3 concentrations in pregnant women with (n=44) and without L-PrE (n=44). These three inflammatory markers concentrations measured using enzyme-linked immunosorbent assays were compared.

Detailed Description

This observational case-control study was designed at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey, in the Department of Obstetrics and Gynecology between June 2018 and January 2019. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2018/393). The study strictly adhered to the principles of the Declaration of Helsinki. All subjects included in the study gave oral and written informed consent. Eighty-eight women were enrolled in the study in two groups. All participants will gave their oral and written informed consent before their inclusion in the study.

Study Timeline

• Study Start: 2018-06-06
• Primary Completion: 2019-01-30
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-12
• Last Update Submitted: 2019-10-12
• Study First Posted: 2019-10-15
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• preeclampsia healthy pregnancy

Exclusion Criteria

1. pregnant women with any systemic condition (such as chronic hypertension, inflammatory and rheumatic diseases),
2. using any kind of medication throughout pregnancy (such as acetylsalicylic acid, corticosteroids or heparin),
3. pregnant women who had fever at the time of the first admission,
4. concurrent infections (urinary tract infection, cervicitis, etc.),
5. pregnancies complicated with premature membrane rupture or chorioamnionitis,
6. history of medication for PE treatment at the time of the first admission,
7. patients who had fetal congenital abnormalities or genetic syndromes,
8. drug user,
9. multiple gestations,
10. active labor.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	interleukin-6, presepsin and pentraxin-3	The control groups' samples obtained during the routine obstetrical care examination in the third trimester of pregnancy. Then these pregnant women followed-up until the delivery.
late-onset preeclampsia	interleukin-6, presepsin and pentraxin-3	The diagnosis of L-PrE, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), is established based on the presence of proteinuria (urinary excretion of protein ≥300 mg in a 24-h urine specimen, or proteinüria ≥1+ in dipstick) and a blood pressure level of ≥90/140 mmHg (two blood pressure measurements 6 h apart) that occurs after 34 weeks of gestation in a previously normotensive woman. The diastolic and/or systolic blood pressure \<110/160 mm Hg, it was accepted as mild; and in case these values exceeded this level, it was accepted as severe. The study population consisted of 50 late-onset preeclampsia patients as study group and 50 patients with normal pregnancies as control group.

Primary Outcome Measures

Name	Time	Method
The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia group and control group.	3 months	The primary endpoint in these analyses was IL-6, presepsin and pentraxin-3 levels in late-onset preeclampsia and control group.

Trial Locations

Locations (1)

Cengiz Gokcek Women's and Child's hospital; 🇹🇷 Gaziantep, Turkey