Thiol/Disulphide Homeostasis and Preeclampsia (thiols&PE)

Cengiz Gokcek Women's and Children's Hospital

Status: Completed

Conditions: Preeclampsia

Treatments: Other: thiol/disulfide levels

Study type: Observational

Funder types: Other

Identifiers

NCT03927014

CengizGWCH2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Preeclampsia

Description:

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.

Treatment:

Other: thiol/disulfide levels

Control

Description:

The control groups' samples will obtain during the routine obstetrical care examination in the third trimester of pregnancy.

Treatment:

Other: thiol/disulfide levels