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Thiol/Disulphide Homeostasis and Preeclampsia (thiols&PE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927014
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital

Tracking Information
First Submitted Date April 23, 2019
First Posted Date April 25, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date April 25, 2019
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Thiol/Disulphide Homeostasis and Preeclampsia
Official Title Serum Thiol/Disulphide Homeostasis Level and Its Correlation With the Severity of Preeclampsia
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts
  • 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.
    Intervention: Other: thiol/disulfide levels
  • Control
    The control groups' samples will obtain during the routine obstetrical care examination in the third trimester of pregnancy.
    Intervention: Other: thiol/disulfide levels
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2019)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date February 5, 2020
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: pregnancy
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03927014
Other Study ID Numbers CengizGWCH2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital
Study Sponsor Cengiz Gokcek Women's and Children's Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ali Ovayolu, MD Cengiz Gokcek WCH
PRS Account Cengiz Gokcek Women's and Children's Hospital
Verification Date June 2020