Clinical trial NCT01348191: Detection of Thyrotrophin Receptor in Human Myometrium
Official title: Detection of Thyrotrophin Receptor in Human Myometrium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyrothrophin Receptor in Myometrium Tissue
Keywords: Thyrotrophin
Pregnancy
Human myometrium
Relaxation
Contractility
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Stichting PAMM
name: Tilburg University
name: Erasmus Medical Center
name: Eindhoven University of Technology
First posted: 2011-05-05
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women (n=10) with a term ( \> 37 weeks) baby, who are scheduled for elective caesarean section.

Brief 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.

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 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

Primary outcomes:
measure: Thyrothrophin receptor
timeFrame: three months
Secondary outcomes:
measure: electropotentials in myometrium and relaxation and contractility
timeFrame: Three months
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina-hospital
state: Brabant
city: Eindhoven
country: Netherlands
facility: Eindhoven University of Technology
state: Brabant
city: Tilburg
country: Netherlands
facility: University of Tilburg
state: Brabant
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Catharina-ziekenhuis, Eindhoven, the Netherlands
name: simone M Kuppens, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tilburg, Department of Medical and Neuropsychology
name: Victor J Pop, MD,PhD,Prof
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/s0002-9378(03)00853-6.
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. doi: 10.1267/ahc.06026.
citation: 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.
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. doi: 10.1530/eje.1.02279.
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.
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.