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Thiol/Disulphide Homeostasis and Preeclampsia (thiols&PE)

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ClinicalTrials.gov Identifier: NCT03927014
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital

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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927014


Contacts
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Contact: ali Ovayolu, MD 00905326404060 drovayolu@yahoo.com
Contact: Erbil Karaman, MD 00905555080712 erbil84@gmail.com

Locations
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Turkey
Cengiz Gokcek Women's and Child's hospital Recruiting
Gaziantep, Turkey, 27010
Contact: Ali Ovayolu, MD    00905326404060    drovayolu@yahoo.com   
Sponsors and Collaborators
Cengiz Gokcek Women's and Children's Hospital
Investigators
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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:

Publications of Results:
Other Publications:
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Responsible Party: Ali Ovayolu, Principal Investigator, Cengiz Gokcek Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT03927014     History of Changes
Other Study ID Numbers: CengizGWCH2
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications