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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thyrothrophin receptor
Time Frame: three months
Immunodetection of Thyrothrophin receptor in myometrium tissue
three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catharina Ziekenhuis Eindhoven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Erasmus Medical Center
Tilburg University
Stichting PAMM
Eindhoven University of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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