Detection of Thyrotrophin Receptor in Human Myometrium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thyrothrophin Receptor in Myometrium Tissue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Elective caesarean section

Population: 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

Myometrial biopsy

Intervention Type PROCEDURE

At caesarean section, after birth of the baby but before closure of the uterus, a biopsy from the upper lip of the incision in the lower uterine segment will be taken. This biopsy will measure approximately 2x50mm.

Interventions

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Myometrial biopsy

At caesarean section, after birth of the baby but before closure of the uterus, a biopsy from the upper lip of the incision in the lower uterine segment will be taken. This biopsy will measure approximately 2x50mm.

Intervention Type PROCEDURE

Other Intervention Names

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Thyrotrophin Myometrium Relaxation Contractility Conductance Electropotentials

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes