Implication of Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in the Pathogenesis of Preeclampsia and in Pregnancy Related Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Vaspin level
研究概览
简要总结
The aim of the present study is to evaluate the implication of adipokines, inflammation, insulin resistance and endothelial dysfunction in the pathogenesis of preeclampsia and in pregnancy related complications.
详细描述
This observational parallel study will be conducted on pregnant women with normal pregnancy, pregnant women with Preeclampsia, and on healthy non-pregnant women. All participants will be recruited from the Outpatient Clinic of Obstetrics and Gynecology Department at Menoufia University Hospital (Shebin El-Kom, Egypt). The study will be approved by the Research Ethics Committee of Menoufia University and all the involved subjects will give their written informed consent.
This study will involve a total number of 60 women who will be further classified into: 20 non-pregnant women who serve as the control group (group 1), 20 pregnant women with normal pregnancy at their third trimesters (group 2) and 20 pregnant women with Preeclampsia at their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. The pregnant women will be assessed in their third trimesters and further re-evaluated 4 weeks after delivery. The gestational ages will be determined conventionally and re-affirmed by ultrasonographic measurement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with normal pregnancy (n=20)
- •Pregnant women with Preeclampsia (n=20) at their third trimesters of pregnancy will be included in the study. Preeclampsia will be defined and diagnosed by constant elevation in blood pressure greater than 140/90 mmHg and by the presence of proteinuria above 300 mg /24 hour with the absence of both urinary tract infection and previous history of hypertension.
- •Apparently healthy non-pregnant females (n=20) will be included in this study also.
排除标准
- •Women with risk factors for oxidative stress such as smokers and
- •Those with a medical history of diabetes mellitus (DM) and Tuberculosis (T.B).
- •Women with a history of hypertension, familial hyperlipidemia, liver diseases, inflammatory diseases, and renal impairment.
- •Non-pregnant women on hormonal therapy or hormonal contraceptives.
结局指标
主要结局
Vaspin level
时间窗: Nine months
Serum vaspin concentrations will be assayed using commercially available ELISA kits
resistin level
时间窗: Nine months
Serum resistin concentrations will be assayed using commercially available ELISA kits
Interleukin 18
时间窗: Nine months
IL-18 will be carried out using Enzyme-Linked Immunosorbent Assay
Malondialdehyde level
时间窗: Nine Months
MDA will be measured spectrophotometrically
Serum asymmetteric dimethyl arginine (ADMA)
时间窗: Nine Months
Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
insulin resistance (IR)
时间窗: Nine Months
insulin resistance (IR) using the HOMA-IR index \[18\], which is defined as fasting insulin (μIU/ml) times fasting glucose (mmol/l) divided by 22.5 or divided by 405 if fasting blood glucose is expressed in mass units (mg/dl).
次要结局
未报告次要终点
研究者
Dr. Tarek Mohamed Mostafa
Associate Professor
Tanta University