Detection of Thyrotrophin Receptor in Human Myometrium

This study has been completed.
Sponsor:
Collaborators:
Stichting PAMM
University of Tilburg
Erasmus Medical Center
Eindhoven University of Technology
Information provided by (Responsible Party):
S.Kuppens, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01348191
First received: May 4, 2011
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Thyrothrophin Receptor in Myometrium Tissue
Procedure: Myometrial biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Thyrotrophin Receptor in Human Myometrium

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • Thyrothrophin receptor [ Time Frame: three months ] [ Designated as safety issue: No ]
    Immunodetection of Thyrothrophin receptor in myometrium tissue


Secondary Outcome Measures:
  • electropotentials in myometrium and relaxation and contractility [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Investigation of relaxation and contractility of myometrium. Conductance of electropotentials of myometrium tissue


Biospecimen Retention:   Samples Without DNA

Biopsy of human myometrium


Enrollment: 10
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • Thyrotrophin
  • Myometrium
  • Relaxation
  • Contractility
  • Conductance
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348191

Locations
Netherlands
Catharina-hospital
Eindhoven, Brabant, Netherlands, 5602 ZA
Eindhoven University of Technology
Eindhoven, Brabant, Netherlands, 5612 AZ
University of Tilburg
Tilburg, Brabant, Netherlands, 5000 LE
Erasmus MC
Rotterdam, Zuid-Holland, Netherlands, 3015 GE
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Stichting PAMM
University of Tilburg
Erasmus Medical Center
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
  More Information

Publications:
Responsible Party: S.Kuppens, MD, Phd, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01348191     History of Changes
Other Study ID Numbers: NL36261.060.11
Study First Received: May 4, 2011
Last Updated: May 23, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Catharina Ziekenhuis Eindhoven:
Thyrotrophin
Pregnancy
Human myometrium
Relaxation
Contractility

ClinicalTrials.gov processed this record on July 24, 2014