Thiol/Disulphide Homeostasis and Preeclampsia

Preeclampsia Clinical Trial

— thiols&PE  

Official title:

Serum Thiol/Disulphide Homeostasis Level and Its Correlation With the Severity of Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927014
• Other study ID #: CengizGWCH2
• Status: Completed
• Start date: April 25, 2019
• Est. completion date: February 5, 2020

Study information

• Verified date: June 2020
• Source: Cengiz Gokcek Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 5, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
Turkey	Cengiz Gokcek Women's and Child's hospital	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Cengiz Gokcek Women's and Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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