Detection of Thyrotrophin Receptor in Human Myometrium

May 23, 2013 updated by: S.Kuppens, Catharina Ziekenhuis Eindhoven

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Brabant
      • Eindhoven, Brabant, Netherlands, 5602 ZA
        • Catharina-Hospital
      • Eindhoven, Brabant, Netherlands, 5612 AZ
        • Eindhoven University of Technology
      • Tilburg, Brabant, Netherlands, 5000 LE
        • University of Tilburg
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GE
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women (n=10) with a term ( > 37 weeks) baby, who are scheduled for elective caesarean section.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: 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.
Other Names:
  • Relaxation
  • Thyrotrophin
  • Myometrium
  • Contractility
  • Conductance
  • Electropotentials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyrothrophin receptor
Time Frame: three months
Immunodetection of Thyrothrophin receptor in myometrium tissue
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
electropotentials in myometrium and relaxation and contractility
Time Frame: Three months
Investigation of relaxation and contractility of myometrium. Conductance of electropotentials of myometrium tissue
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Collaborators

Erasmus Medical Center
Tilburg University
Stichting PAMM
Eindhoven University of Technology

Investigators

  • Principal Investigator: simone M Kuppens, MD,PhD, Catharina-ziekenhuis, Eindhoven, the Netherlands
  • Study Director: Victor J Pop, MD,PhD,Prof, University of Tilburg, Department of Medical and Neuropsychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NL36261.060.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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