NCT02992145已完成不适用
Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total and free testosterone level
研究概览
简要总结
This study aims to compare between androgens level (serum total and free testosterone) in women with preeclampsia and normal ones in the third trimester of pregnancy (28-40 weeks).
详细描述
Methodology:
All women in this study will be subjected to:
- All women are candidates for this study according to inclusion and exclusion criteria.
- History taking with special emphases on last menstrual period to determine the exact Gestational age.
- A reliable date is defined as the occurrence of regular menstrual cycles (28±7 days) in patients who have not taken oral contraceptives during the three months before conception and have no irregular bleeding.
- General and abdominal examination for each patient to determine those patients matching with the inclusion criteria.
- Preeclampsia refers to the new onset of hypertension (systolic blood pressure ≥140 mmHg ,or diastolic blood pressure≥ 90 mmHg ,or both, measured on two occasions > 6 hours apart) and either proteinuria or end organ dysfunction after 20 weeks of gestation in a previously normotensive woman.
- At Ain Shams University Hospitals, the investigator will use ELISA based test system intended for the quantitative measurement of total and free testosterone for patients of both groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women (primigravidas) at third trimester i.e. 28-40 weeks.
- •Age between 20 and 35 years old.
- •Live fetus.
- •Having no history of pregestational hypertension.
- •Having no history of diseases associated with hormone disorders (thyroid gland disorders, DM, hyperprolactinemia or polycystic ovary syndrome).
- •During their pregnancy they did not receive antihypertensive medications.
排除标准
- •1- First and second trimester pregnant women. 2- Women younger than 20 years old and older than 35 years old 3- Intrauterine fetal death. 4- History of pregestational hypertension. 5- History of hormonal disorders (thyroid gland disorders and hyperprolactinemia).
- •6- Smoker. 7- Polycystic ovary syndrome. 8- Signs or symptoms of hyper-androgenism (hirsutism, acne, oily skin, etc.). 9- Diabetes mellitus. 10- Drug use except ordinary supplementation (iron, folic acid).
结局指标
主要结局
Total and free testosterone level
时间窗: 9 months
Higher in preeclamptic patients than normal pregnant ladies
次要结局
未报告次要终点
研究者
Ahmed Ismail Ahmed Mohamed
Obstetrics and gynaecology resident
Ain Shams Maternity Hospital
研究点 (1)
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