Serum Soluble Endoglin and Matrix Metalloproteinase 14 With Elisa Method in Early/Late-onset Preeclampsia

Completed

• Conditions: Preeclampsia

• Registration Number: NCT03932877
• Lead Sponsor: Cengiz Gokcek Women's and Children's Hospital

Brief Summary

Objective: Defective placentation and inadequate trophoblastic invasion have an important place in the aetiology of preeclampsia (PrE). Trophoblasts invade the maternal decidua and remodel spiral arteries with matrix metalloproteinase-14 (MMP-14). To the best of our knowledge, studies of MMP-14 protein levels of PrE patients' sera remain unpublished. This study aims to investigate the value of serum MMP-14 and soluble endoglin (s-ENG) in PrE patients and healthy controls.

Methods: The study was conducted with 30 late-onset preeclampsia patients (L-PrE) as group1 (gestational age≥34 weeks), 33 patients with normal pregnancies as group2 (gestational age≥34 weeks), 31 early-onset preeclampsia patients (E-PrE) as group3 (gestational age\<34 weeks), and 31 patients with normal pregnancies as group 4 (gestational age\<34 weeks). Serum MMP-14 and s-ENG levels measured by ELISA were compared.

Detailed Description

The study was conducted at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey at department of obstetrics and gynecology between date of January 2018 and December 2018. The study protocol was designed according to the Declaration of Helsinki, and the institutional ethical review board of Gaziantep University approved the study (Reference number: 2018/91). One hundred twenty-five women enrolled in the study in four groups. The investigators consecutively recruited 61 pregnancies complicated with preeclampsia, and 64 healthy pregnancies will select for the control group. All participiants gave their oral and written informed consent before their inclusion in the study.

Study Timeline

• Study Start: 2018-01-30
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-30
• Status Verified: 2019-04
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-27
• Last Update Submitted: 2019-04-30
• Study First Posted: 2019-05-01
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

• preeclampsia
• healthy pregnancy

Exclusion Criteria

• pregnant women with any systemic condition (such as chronic hypertension, diabetes mellitus, thyroid diseases, liver and kidney diseases)
• women with a history of drug use throughout pregnancy
• history of medication for PE treatment at the time of first admission
• patients who had fetal congenital abnormalities or genetic syndromes
• multiple gestations
• active labour

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum matrix metalloproteinase-14 levels in preeclampsia	1 day	The primary endpoint in this analysis is to evaluate the value of serum matrix metalloproteinase-14 levels (ng/ml) in preeclampsia patients and also address its relationship with its severity.

Secondary Outcome Measures

Name	Time	Method
Serum soluble endoglin levels in preeclampsia	1 day	The secondary endpoint in this analysis is to evaluate the value of serum soluble endoglin levels (ng/ml) in preeclampsia patients and also address its relationship with its severity.

Trial Locations

Locations (1)

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