Detection of Thyrotrophin Receptor in Human Myometrium

Thyrothrophin Receptor in Myometrium Tissue Clinical Trial

Official title:

Detection of Thyrotrophin Receptor in Human Myometrium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348191
• Other study ID #: NL36261.060.11
• Status: Completed
• Phase: N/A
• First received: May 4, 2011
• Last updated: May 23, 2013
• Start date: November 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thyrothrophin Receptor in Myometrium Tissue

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Catharina-hospital	Eindhoven	Brabant
Netherlands	Eindhoven University of Technology	Eindhoven	Brabant
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland
Netherlands	University of Tilburg	Tilburg	Brabant

Sponsors (5)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Eindhoven University of Technology, Erasmus Medical Center, Stichting PAMM, University of Tilburg

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

Heemstra KA, van der Deure WM, Peeters RP, Hamdy NA, Stokkel MP, Corssmit EP, Romijn JA, Visser TJ, Smit JW. Thyroid hormone independent associations between serum TSH levels and indicators of bone turnover in cured patients with differentiated thyroid carcinoma. Eur J Endocrinol. 2008 Jul;159(1):69-76. doi: 10.1530/EJE-08-0038. Epub 2008 Apr 7. — View Citation

Kooistra L, Kuppens SM, Hasaart TH, Vader HL, Wijnen HA, Oei SG, Pop VJ. High thyrotrophin levels at end term increase the risk of breech presentation. Clin Endocrinol (Oxf). 2010 Nov;73(5):661-5. doi: 10.1111/j.1365-2265.2010.03846.x. — View Citation

Kuppens SM, Kooistra L, Wijnen HA, Crawford S, Vader HL, Hasaart TH, Oei SG, Pop VJ. Maternal thyroid function during gestation is related to breech presentation at term. Clin Endocrinol (Oxf). 2010 Jun;72(6):820-4. doi: 10.1111/j.1365-2265.2009.03729.x. Epub 2009 Oct 15. — View Citation

Oner J, Oner H. Immunodetection of thyroid hormone receptor (alpha1/alpha2) in the rat uterus and oviduct. Acta Histochem Cytochem. 2007 Jul 3;40(3):77-81. — View Citation

Peeters RP, van der Deure WM, Visser TJ. Genetic variation in thyroid hormone pathway genes; polymorphisms in the TSH receptor and the iodothyronine deiodinases. Eur J Endocrinol. 2006 Nov;155(5):655-62. Review. — View Citation

Potter SM, Astbury K, Morrison JJ. Effects of thyrotropin-releasing hormone on human myometrium and umbilical vasculature in vitro. Am J Obstet Gynecol. 2004 Jan;190(1):246-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thyrothrophin receptor	Immunodetection of Thyrothrophin receptor in myometrium tissue	three months	No
Secondary	electropotentials in myometrium and relaxation and contractility	Investigation of relaxation and contractility of myometrium. Conductance of electropotentials of myometrium tissue	Three months	No