Thiol/Disulphide Homeostasis and Preeclampsia (thiols&PE)

• ClinicalTrials.gov Identifier: NCT03927014
• Recruitment Status: Completed
• First Posted: April 25, 2019
• Last Update Posted: June 11, 2020
• Sponsor: Cengiz Gokcek Women's and Children's Hospital
• Information provided by (Responsible Party): Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Preeclampsia	Other: thiol/disulfide levels

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Serum Thiol/Disulphide Homeostasis Level and Its Correlation With the Severity of Preeclampsia
• Actual Study Start Date: April 25, 2019
• Actual Primary Completion Date: January 1, 2020
• Actual Study Completion Date: February 5, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; 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.	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Thiol/ disulfide hemostasis [ Time Frame: 1 day ]
   The primary endpoint in this analysis is to evaluate thiol/disulfide levels in preeclampsia and address its relationship with its severity.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: pregnancy
• Accepts Healthy Volunteers: Yes
• 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.

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

Contacts and Locations

Locations

Turkey

Cengiz Gokcek Women's and Child's hospital

Gaziantep, Turkey, 27010

Sponsors and Collaborators

Cengiz Gokcek Women's and Children's Hospital

Investigators

• Principal Investigator: Ali Ovayolu, MD; Cengiz Gokcek WCH

  Study Documents (Full-Text)

Documents provided by Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] May 10, 2020

More Information

Publications of Results:

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.

Other Publications:

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. Epub 2015 Nov 20.

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.

• Responsible Party: Ali Ovayolu, Principal Investigator, Cengiz Gokcek Women's and Children's Hospital
• ClinicalTrials.gov Identifier: NCT03927014
• Other Study ID Numbers: CengizGWCH2
• First Posted: April 25, 2019
• Last Update Posted: June 11, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital:

oxidative stress; mercaptan; severity

Additional relevant MeSH terms:

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications