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Completed

NCT Number: NCT01348191

Detection of Thyrotrophin Receptor in Human Myometrium

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Catharina-hospital, Eindhoven, North Brabant, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myometrial biopsy

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.

Other names: Thyrotrophin, Myometrium, Relaxation, Contractility, Conductance, Electropotentials

Primary outcomes

  1. Thyrothrophin receptor

    Time frame: three months

    Immunodetection of Thyrothrophin receptor in myometrium tissue

Secondary outcomes

  1. electropotentials in myometrium and relaxation and contractility

    Time frame: Three months

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

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Eindhoven University of Technology
  • Erasmus Medical Center
  • Stichting PAMM
  • Tilburg University

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 5, 2011
Registry last updated
May 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.