Thiol/Disulphide Homeostasis and Preeclampsia

Completed

• Conditions: Preeclampsia
• Interventions: Other: thiol/disulfide levels

• Registration Number: NCT03927014
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-23
• Study Start: 2019-04-25
• Study First Posted: 2019-04-25
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	thiol/disulfide levels	The control groups' samples will obtain during the routine obstetrical care examination in the third trimester of pregnancy.
Preeclampsia	thiol/disulfide levels	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cengiz Gokcek Women's and Child's hospital; 🇹🇷 Gaziantep, Turkey