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Detection of Thyrotrophin Receptor in Human Myometrium

Detection of Thyrotrophin Receptor in Human Myometrium

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01348191
Enrollment
10
Registered
2011-05-05
Start date
2011-11-30
Completion date
2013-01-31
Last updated
2013-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyrothrophin Receptor in Myometrium Tissue

Keywords

Thyrotrophin, Pregnancy, Human myometrium, Relaxation, Contractility

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.

Interventions

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.

Sponsors

Stichting PAMM
CollaboratorUNKNOWN
Tilburg University
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
Eindhoven University of Technology
CollaboratorOTHER
Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Thyrothrophin receptorthree monthsImmunodetection of Thyrothrophin receptor in myometrium tissue

Secondary

MeasureTime frameDescription
electropotentials in myometrium and relaxation and contractilityThree monthsInvestigation of relaxation and contractility of myometrium. Conductance of electropotentials of myometrium tissue

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026