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Detection of Thyrotrophin Receptor in Human Myometrium

Completed
Conditions
Thyrothrophin Receptor in Myometrium Tissue
Interventions
Procedure: Myometrial biopsy
Registration Number
NCT01348191
Lead Sponsor
Catharina Ziekenhuis Eindhoven
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
10
Inclusion Criteria
  • Elective caesarean section
  • Term pregnancy > 37 weeks
  • Age > 18 years
Exclusion Criteria
  • 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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Elective caesarean sectionMyometrial biopsyPopulation: ten pregnant women, scheduled for elective caesarean section with a term pregnancy ( \> 37 weeks). Inclusion criteria * Elective caesarean section * Term pregnancy \> 37 weeks * Age \> 18 years Exclusion criteria * 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
Primary Outcome Measures
NameTimeMethod
Thyrothrophin receptorthree months

Immunodetection of Thyrothrophin receptor in myometrium tissue

Secondary Outcome Measures
NameTimeMethod
electropotentials in myometrium and relaxation and contractilityThree months

Investigation of relaxation and contractility of myometrium. Conductance of electropotentials of myometrium tissue

Trial Locations

Locations (4)

Erasmus MC

🇳🇱

Rotterdam, Zuid-Holland, Netherlands

University of Tilburg

🇳🇱

Tilburg, Brabant, Netherlands

Catharina-hospital

🇳🇱

Eindhoven, Brabant, Netherlands

Eindhoven University of Technology

🇳🇱

Eindhoven, Brabant, Netherlands

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