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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Thiol/Disulphide Homeostasis and Preeclampsia

Clinicaltrials.gov identifier NCT03927014

Recruitment Status Completed

First Posted April 25, 2019

Last update posted June 11, 2020

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:Preeclampsia
  • Intervention/Treatment: Other: thiol/disulfide levels
  • Phase: N/A
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 2019
  • Actual Primary Completion Date: January 2020
  • Actual Study Completion Date: February 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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.
: 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.
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 to 40 Years (Adult)
  • Sexes Eligible for Study: Female
  • 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
Contacts
Locations

Turkey
Cengiz Gokcek Women's and Child's hospital
Gaziantep

Sponsors and Collaborators

Cengiz Gokcek Women's and Children's Hospital

Investigators

Principal Investigator: Ali Ovayolu, MD Cengiz Gokcek WCH

More Information