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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

May 4, 2011
May 23, 2013
November 2011
September 2012   (final data collection date for primary outcome measure)
Thyrothrophin receptor [ Time Frame: three months ] [ Designated as safety issue: No ]
Immunodetection of Thyrothrophin receptor in myometrium tissue
TSH receptor [ Time Frame: one month ] [ Designated as safety issue: No ]
Immunodetection of Thyrothrophin (TSH) receptor in myometrium tissue
Complete list of historical versions of study NCT01348191 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Detection of Thyrotrophin Receptor in Human Myometrium
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Biopsy of human myometrium

Non-Probability Sample

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

Thyrothrophin Receptor in Myometrium Tissue
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
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
Intervention: Procedure: Myometrial biopsy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2013
September 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01348191
NL36261.060.11
Yes
S.Kuppens, Catharina Ziekenhuis Eindhoven
Catharina Ziekenhuis Eindhoven
  • Stichting PAMM
  • University of Tilburg
  • Erasmus Medical Center
  • Eindhoven University of Technology
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
Catharina Ziekenhuis Eindhoven
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP