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临床试验/NCT03064412
NCT03064412已完成不适用

Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels

Unity Health Toronto0 个研究点目标入组 70 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
主要终点
Changes in sex steroids

研究概览

简要总结

Androgens are important sex steroids in women. Androgens influence protein synthesis and muscle growth, are involved in maturation of the reproductive organs, have a fat reducing effect , have a negative effect on the serum lipid profile, and may also increase insulin resistance and coagulation activity. The role of androgens in women is not clear. This study is aimed at learning about the amount of androgen and its actions in pregnant women. This study is also looking to see if there are specific patient factors (such as genetics) that change the amount of androgen and its activity.

详细描述

There is a lot of information about the main female sex hormones such as estrogens and progesterones (the main female sex hormones and the most important in menstrual , reproductive cycles and pregnancy) . However there is little information about androgens in pregnant women. It is known that certain illnesses, chemicals and dietary products might change the amount of androgen and its actions, which could affect the mother and her baby. It is also known that there are differences between the androgen levels in different people, and in different ethnic groups. These differences are mostly due to genetic factors. The goal of this study is to learn about the androgen levels in healthy pregnant women and if genetic or clinical factors (for example age, trimester of pregnancy, parity, ethnicity, etc.) play a role in changing the androgen amount and action, throughout pregnancy and after delivery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

  • healthy women without drug treatment, in the age range of 18-40 years

排除标准

  • Any chronic disease such as Hypertension or Diabetes Mellitus
  • Positive for HIV, hepatitis, Syphilis
  • Abnormal laboratory test results (e.g. abnormal TSH, glucose, creatinine, HIV, HBV, VDRL)
  • Ongoing hormonal treatment-e.g. progesterone, estrogen or other
  • Smoking cigarettes, alcohol, regular substance use
  • Confirmed or suspected abuse of drugs
  • Chronic prescription drugs
  • Pre-existing diabetes or GDM in last pregnancy

结局指标

主要结局

Changes in sex steroids

时间窗: 1st trimester (1-12 weeks gestation), 2nd trimester (13-28 weeks gestation), 3rd trimester (28-40 weeks gestation), 6 weeks post-partum

Changes to levels of sex steroids throughout pregnancy and after delivery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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