Thiol/Disulphide Homeostasis and Preeclampsia

NCT03927014 | Completed

• 1 other identifier: CengizGWCH2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Keywords

oxidative stress; mercaptan; severity

Outcome Measures

Primary Outcomes (1)

• Thiol/ disulfide hemostasis

  The primary endpoint in this analysis is to evaluate thiol/disulfide levels in preeclampsia and address its relationship with its severity.

  1 day

Study Arms (2)

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.

Other: thiol/disulfide levels

Control

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

Other: thiol/disulfide levels

Interventions

thiol/disulfide levels 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; Preeclampsia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The investigators consecutively will recruit 50 subjects with preeclampsia, and 50 healthy pregnancies will select for the control group.

You may qualify if:

• preeclampsia
• healthy pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Cengiz Gokcek Women's and Children's Hospital: lead

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 26588703 BACKGROUND

• 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.

  PMID: 27939489 BACKGROUND

• 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.

  PMID: 26828694 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Sulfhydryl Compounds

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfur Compounds; Organic Chemicals

Study Officials

• Ali Ovayolu, MD

  Cengiz Gokcek WCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: April 25, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 5, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

TU (1)