Detection of Thyrotrophin Receptor in Human Myometrium
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Thyrothrophin Receptor in Myometrium Tissue |
Procedure: Myometrial biopsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Detection of Thyrotrophin Receptor in Human Myometrium |
- Thyrothrophin receptor [ Time Frame: three months ] [ Designated as safety issue: No ]Immunodetection of Thyrothrophin receptor in myometrium tissue
- 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
Biospecimen Retention: Samples Without DNA
Biopsy of human myometrium
| Enrollment: | 10 |
| Study Start Date: | November 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Elective caesarean section
Population: ten pregnant women, scheduled for elective caesarean section with a term pregnancy ( > 37 weeks). Inclusion criteria
Exclusion criteria
|
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:
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pregnant women (n=10) with a term ( > 37 weeks) baby, who are scheduled for elective caesarean section.
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
Contacts and Locations| Netherlands | |
| Catharina-hospital | |
| Eindhoven, Brabant, Netherlands, 5602 ZA | |
| Eindhoven University of Technology | |
| Eindhoven, Brabant, Netherlands, 5612 AZ | |
| University of Tilburg | |
| Tilburg, Brabant, Netherlands, 5000 LE | |
| Erasmus MC | |
| Rotterdam, Zuid-Holland, Netherlands, 3015 GE | |
| 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 |
More Information
Publications:
| Responsible Party: | S.Kuppens, MD, Phd, Catharina Ziekenhuis Eindhoven |
| ClinicalTrials.gov Identifier: | NCT01348191 History of Changes |
| Other Study ID Numbers: | NL36261.060.11 |
| Study First Received: | May 4, 2011 |
| Last Updated: | May 23, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Catharina Ziekenhuis Eindhoven:
|
Thyrotrophin Pregnancy Human myometrium Relaxation Contractility |
ClinicalTrials.gov processed this record on May 23, 2013