Detection of Thyrotrophin Receptor in Human Myometrium

NCT01348191 | Completed DMC

• 1 other identifier: NL36261.060.11
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 4

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.

Conditions

Thyrothrophin Receptor in Myometrium Tissue

Keywords

Thyrotrophin; Pregnancy; Human myometrium; Relaxation; Contractility

Outcome Measures

Primary Outcomes (1)

• Thyrothrophin receptor

  Immunodetection of Thyrothrophin receptor in myometrium tissue

  three months

Secondary Outcomes (1)

• electropotentials in myometrium and relaxation and contractility

  Three months

Study Arms (1)

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

Interventions

Myometrial biopsy PROCEDURE

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.

Also known as: Thyrotrophin, Myometrium, Relaxation, Contractility, Conductance, Electropotentials

Elective caesarean section

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Elective caesarean section
• Term pregnancy \> 37 weeks
• Age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Stichting PAMM: collaborator
• Tilburg University: collaborator
• Erasmus Medical Center: collaborator
• Eindhoven University of Technology: collaborator

Study Sites (4)

Catharina-hospital

Eindhoven, North Brabant, 5602 ZA, Netherlands

Location

Eindhoven University of Technology

Eindhoven, North Brabant, 5612 AZ, Netherlands

Location

University of Tilburg

Tilburg, North Brabant, 5000 LE, Netherlands

Location

Erasmus MC

Rotterdam, South Holland, 3015 GE, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 14749667 BACKGROUND

• 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.

  PMID: 17653299 BACKGROUND

• 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.

  PMID: 18390987 BACKGROUND

• 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.

  PMID: 17062880 BACKGROUND

• 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.

  PMID: 19832853 BACKGROUND

• 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.

  PMID: 20718770 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy of human myometrium

MeSH Terms

Interventions

Thyrotropin; Myocardial Contraction

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Muscle Contraction; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• simone M Kuppens, MD,PhD

  Catharina-ziekenhuis, Eindhoven, the Netherlands

  PRINCIPAL INVESTIGATOR

• Victor J Pop, MD,PhD,Prof

  University of Tilburg, Department of Medical and Neuropsychology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Phd

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 5, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

NL (4)