Clinical trial NCT03927014: Thiol/Disulphide Homeostasis and Preeclampsia
Official title: Serum Thiol/Disulphide Homeostasis Level and Its Correlation With the Severity of Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: oxidative stress
mercaptan
severity
Lead sponsor: Cengiz Gokcek Women's and Children's Hospital
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Thiol/ disulfide hemostasis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Cengiz Gokcek Women's and Child's hospital
Study officials:
affiliation: Cengiz Gokcek WCH
name: Ali Ovayolu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozler S, Erel O, Oztas E, Ersoy AO, Ergin M, Sucak A, Neselioglu S, Uygur D, Danisman N. Serum Thiol/Disulphide Homeostasis in Preeclampsia. Hypertens Pregnancy. 2015 Nov;34(4):474-485. doi: 10.3109/10641955.2015.1077859. Epub 2015 Nov 20.
citation: Yuvaci HU, Akdemir N, Bostanci MS, Yazar H, Cevrioglu S, Ozden S, Unal O, Paker MK, Neselioglu S, Erel O. Evaluation of the level of thiol-disulphide homeostasis in patients with mild and severe preeclampsia. Pregnancy Hypertens. 2016 Oct;6(4):394-399. doi: 10.1016/j.preghy.2016.09.003. Epub 2016 Sep 21. No abstract available.
citation: Korkmaz V, Kurdoglu Z, Alisik M, Cetin O, Korkmaz H, Surer H, Erel O. Impairment of thiol-disulfide homeostasis in preeclampsia. J Matern Fetal Neonatal Med. 2016 Dec;29(23):3848-53. doi: 10.3109/14767058.2016.1149561. Epub 2016 Mar 3.