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临床试验/NCT05591638
NCT05591638尚未招募不适用

Comparison of Docosahexaenoic Acid Serum Levels in Patients With Preeclampsia and Control Group

Recep Tayyip Erdogan University Training and Research Hospital0 个研究点目标入组 90 人开始时间: 2022年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
主要终点
docosahexaenoic acid

研究概览

简要总结

By comparing the blood levels of docosahexaenoic acid (DHA) in preeclamptic patients with normal pregnant women, we aim to reveal the relationship between these markers, which are known to be effective on metabolic function, and preeclampsia, and to contribute to future studies and possible treatment options

详细描述

The research is a prospective cross-sectional study to be conducted at Recep Tayyip Erdogan University Training and Research Hospital, Department of Obstetrics and Gynecology. The current treatments of the patients will not be changed and no medical treatment or interventional procedures will be applied to the patients for study purposes. After the patients are informed about the study, the consent form will be signed, indicating that they voluntarily participated in the study. Apart from the biochemical parameters required for the diagnosis and treatment of the patients, different parameters will not be considered. The supply of Docosahexaenoic Acid kits required for the study will be provided by the executive physician and the blood taken from the patients will be evaluated.

G * Power 3.1.9.7 program was used to calculate the sample size for this study. At 80% statistical power and α=0.05 significance level, the smallest required sample size was calculated as 86 (control 44- study: 42) when d=0.51 effect size was calculated according to t-test for independent groups. Considering that there may be missing data, 90 patients between the ages of 18-40 will be included in the study. There will be 45 patients diagnosed with preeclampsia in the study group. There will be 45 normal pregnant women in the control group.

Preeclamptic patient selection and classification will be made according to the 2019 diagnostic criteria of the American Society of Obstetrics and Gynecology (ACOG). Accordingly, the diagnosis of preeclampsia; After 20 weeks of gestation in a normotensive pregnant woman, hypertension (systolic ≥140 mmHg and/or diastolic ≥90 mmHg) proteinuria or thrombocytopenia with hypertension (platelet <100,000/103 /μL), impaired liver function tests (liver liver function) transaminase blood values to twice the normal concentration), new-onset renal failure (serum creatinine values > 1.1 mg/dL or a two-fold increase in serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral and visual acuity will be placed in case of malfunctions. proteinuria; Proteinuria ≥ 300 mg in 24-hour urine or protein/creatinine ratio ≥ 0.3 or 1+ proteinuria as measured by urine stick. The diagnosis of severe preeclampsia will be made when blood pressure values are systolic ≥160 mmHg and/or diastolic ≥110 mmHg.

Demographic, clinical and laboratory data of the pregnant women included in the study will be recorded. The last menstrual period, obstetric examination and ultrasonography findings will be taken as basis in the determination of the gestational week. For each patient, age, body mass index (BMI), number of births, week of birth, type of birth, birth weight, complete blood count (hemogram), liver function tests (AST, ALT), kidney function tests (urea, creatinine) and full Urine test results will be recorded. In order to avoid the possible effects of corticosteroid and MgSO4 treatments on laboratory parameters in preeclamptic pregnant women, the first laboratory results at hospitalization will be taken into account. In addition, 1st and 5th minute APGAR scores will be noted to assess perinatal outcomes.

Inclusion criteria: Pregnant women aged 18-40, singleton pregnancies, pregnant women with preeclampsia, healthy pregnant women without a history of hypertension before and after pregnancy

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women between the ages of 18-40, singleton pregnancies, pregnant women with preeclampsia, healthy pregnant women who do not have a history of hypertension before and after pregnancy

排除标准

  • Pregnant women diagnosed with chronic hypertension before pregnancy, pregnant women with hypertension before the 20th gestational week, multiple pregnancies, pregnant women with molar pregnancies, women with a body mass index (BMI) >30kg/m2, pregnant women with a history of birth complicated with chromosomal abnormalities, pre-pregnancy or during pregnancy Pregnant women diagnosed with diabetes mellitus, pregnant women diagnosed with chronic systemic diseases, especially rheumatological, renal and vascular diseases, pregnant women diagnosed with chorioamnionitis, pregnant women with polyhydramnios, maternal infection diagnosis

结局指标

主要结局

docosahexaenoic acid

时间窗: 6 months

docosahexaenoic acid levels between groups will be measured

次要结局

未报告次要终点

研究者

发起方
Recep Tayyip Erdogan University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Senol Senturk

Associate professor

Recep Tayyip Erdogan University Training and Research Hospital

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