Thiol/Disulphide Homeostasis and Preeclampsia

NCT ID: NCT03927014

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-25
• Study Completion Date: 2020-02-05

Brief Summary

Objective: To evaluate serum evaluate thiol/ disulfide levels in preeclampsia and address its relationship with its severity.

Methods: This prospective study will include 50 pregnancies complicated with preeclampsia and 50 healthy pregnancies. The blood for analysis will obtain at the admission and serum thiol/ disulfide levels will measure using commercially available reagent kits. The continuous values were evaluated using Student's t-test, and categorical values were evaluated using the Chi-square test. P values < .05 were accepted as significant.

Detailed Description

This is an observational prospective cohort study will conduct at Obstetrics and Gynecology Department of Cengiz Gokcek Obstetrics and Children's Hospital between April and October 2019. One hundred women will enrol in the study in two groups. We will consecutively recruit 50 pregnancies complicated with preeclampsia, and 50 healthy pregnancies will select for the control group. All patients will give their oral and written informed consent before their inclusion in the study. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2019/147). The study strictly will adhere to the principles of the Declaration of Helsinki.

Conditions

Preeclampsia

Study Design

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

Study Groups

Preeclampsia

The diagnosis of preeclampsia, as defined by the Committee on Terminology of the American College of Obstetricians and Gynecologists (ACOG), will establish based on the presence of proteinuria (urinary excretion of 300 mg protein or higher, or at least 1+in dipstick in a 24-h urine specimen) and a blood pressure level of ≥140/90mmHg (two blood pressure measurements 6 h apart) that occurs after 20 weeks of gestation in a previously normotensive woman. Diastolic and/or systolic blood pressure up to 110/160 mm Hg will consider mild, and higher values will consider to being severe.

thiol/disulfide levels

Intervention Type: OTHER

Venous blood will sample from the antecubital veins for measuring the serum concentration of thiol/disulfide levels. The serum thiol/disulfide levels will measure using commercially available reagent kits, which is produced to detect human thiol/disulfide levels (Rel Assay Diagnostics Gaziantep, Turkey). The thiol/disulfide levels measurements were performed in accordance with the company's protocol.

Control

The control groups' samples will obtain during the routine obstetrical care examination in the third trimester of pregnancy.

thiol/disulfide levels

Intervention Type: OTHER

Venous blood will sample from the antecubital veins for measuring the serum concentration of thiol/disulfide levels. The serum thiol/disulfide levels will measure using commercially available reagent kits, which is produced to detect human thiol/disulfide levels (Rel Assay Diagnostics Gaziantep, Turkey). The thiol/disulfide levels measurements were performed in accordance with the company's protocol.

Interventions

thiol/disulfide levels

Venous blood will sample from the antecubital veins for measuring the serum concentration of thiol/disulfide levels. The serum thiol/disulfide levels will measure using commercially available reagent kits, which is produced to detect human thiol/disulfide levels (Rel Assay Diagnostics Gaziantep, Turkey). The thiol/disulfide levels measurements were performed in accordance with the company's protocol.

Intervention Type: OTHER

Eligibility Criteria

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 gestation
• active labor

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

Sponsors

Cengiz Gokcek Women's and Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ali Ovayolu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Ovayolu, MD

Role: PRINCIPAL_INVESTIGATOR

Cengiz Gokcek WCH

Locations

Cengiz Gokcek Women's and Child's hospital

Gaziantep, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ozler S, Erel O, Oztas E, Ersoy AO, Ergin M, Sucak A, Neselioglu S, Uygur D, Danisman N. Serum Thiol/Disulphide Homeostasis in Preeclampsia. Hypertens Pregnancy. 2015 Nov;34(4):474-485. doi: 10.3109/10641955.2015.1077859. Epub 2015 Nov 20.

Reference Type: BACKGROUND

PMID: 26588703 (View on PubMed)

Yuvaci HU, Akdemir N, Bostanci MS, Yazar H, Cevrioglu S, Ozden S, Unal O, Paker MK, Neselioglu S, Erel O. Evaluation of the level of thiol-disulphide homeostasis in patients with mild and severe preeclampsia. Pregnancy Hypertens. 2016 Oct;6(4):394-399. doi: 10.1016/j.preghy.2016.09.003. Epub 2016 Sep 21. No abstract available.

Reference Type: BACKGROUND

PMID: 27939489 (View on PubMed)

Korkmaz V, Kurdoglu Z, Alisik M, Cetin O, Korkmaz H, Surer H, Erel O. Impairment of thiol-disulfide homeostasis in preeclampsia. J Matern Fetal Neonatal Med. 2016 Dec;29(23):3848-53. doi: 10.3109/14767058.2016.1149561. Epub 2016 Mar 3.

Reference Type: RESULT

PMID: 26828694 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CengizGWCH2

Identifier Type: -

Identifier Source: org_study_id