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thiols&PE: Thiol/Disulphide Homeostasis and Preeclampsia

Sponsor
Cengiz Gokcek Women's and Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03927014
Collaborator
(none)
100
Enrollment
1
Location
9.4
Actual Duration (Months)
10.6
Patients Per Site Per Month

Study Details

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 Phase
  • 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 :
Apr 25, 2019
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Feb 5, 2020

Arms and Interventions

Arm 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 [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

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 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)

More Information

Publications

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:
Apr 25, 2019
Last Update Posted:
Jun 11, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
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, Principal Investigator, Cengiz Gokcek Women's and Children's Hospital
oxidative stress
mercaptan
severity
Additional relevant MeSH terms:
Pre-Eclampsia

Study Results

No Results Posted as of Jun 11, 2020