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临床试验/NCT01348191
NCT01348191已完成不适用

Detection of Thyrotrophin Receptor in Human Myometrium

Catharina Ziekenhuis Eindhoven4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
4
主要终点
Thyrothrophin receptor

研究概览

简要总结

It has been recognized for many decades that high thyrotrophin (TSH) levels in pregnant women are associated with poor obstetric outcome. Also, there is evidence that high TSH is related to fetal position at term, including breech which in turn is associated with obstetric complications.

However, the mechanism behind remains to be elucidated.

The current project is of basic-fundamental nature. It is used to better understand basis physiological processes. As in many other studies of similar basic nature, few numbers are always included.

If a TSH receptor will be detected, future randomized controlled trials (RCT) might be worthwhile with large numbers of women who will be treated with thyroxine to possibly prevent abnormal fetal position during normal pregnancy.

The aim of the current study is to evaluate whether a TSH receptor can be demonstrated in human myometrium. If so, the pathophysiology of high TSH in relation to obstetric outcome will become more clear. Furthermore, the aim is to test the myometrium in vitro for its relaxation and contractility and for the conductance of electropotentials.

详细描述

It has been recognized for many decades that high thyrotrophin (TSH) levels in pregnant women are associated with poor obstetric outcome. Also, there is evidence that high TSH is related to fetal position at term, including breech which in turn is associated with obstetric complications.

However, the mechanism behind remains to be elucidated. It has been shown that high TSH affects relaxation and contraction of the smooth muscle in large blood vessels in human. In animals, there is some evidence that TSH interferes with uterine contractility. Although a TSH receptor has been demonstrated outside the thyroid in bone, brain and heart, so far no research on a possible TSH receptor in human uterine tissue has been published.

The current study is a pilot study in which in a limited number of participants (pregnant women, n=10) during elective Caesarean section a uterine specimen will be collected for analysis in a immune-laboratory.

Another part of the specimen will be analysed in a technical laboratory(Technical University of Eindhoven)for analysing the relaxation and contractility of the myometrium and for studying the conductance of electropotentials.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective caesarean section
  • Term pregnancy > 37 weeks
  • Age > 18 years

排除标准

  • Previous caesarean scar
  • Gestational age < 37 weeks
  • Maternal temperature > 37.8 degrees Celsius
  • Meconium stained liquor
  • Foetal distress
  • Maternal diabetes
  • Seropositivity
  • Use of thyroid medication
  • Maternal thyroid disease
  • Age < 18 years

结局指标

主要结局

Thyrothrophin receptor

时间窗: three months

Immunodetection of Thyrothrophin receptor in myometrium tissue

次要结局

  • electropotentials in myometrium and relaxation and contractility(Three months)

研究者

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other
责任方
Principal Investigator
主要研究者

S.Kuppens

MD, Phd

Catharina Ziekenhuis Eindhoven

研究点 (4)

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