Detection of Thyrotrophin Receptor in Human Myometrium
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| First Received Date ICMJE | May 4, 2011 | ||||||||
| Last Updated Date | May 23, 2013 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Thyrothrophin receptor [ Time Frame: three months ] [ Designated as safety issue: No ] Immunodetection of Thyrothrophin receptor in myometrium tissue |
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| Original Primary Outcome Measures ICMJE |
TSH receptor [ Time Frame: one month ] [ Designated as safety issue: No ] Immunodetection of Thyrothrophin (TSH) receptor in myometrium tissue |
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| Change History | Complete list of historical versions of study NCT01348191 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Detection of Thyrotrophin Receptor in Human Myometrium | ||||||||
| Official Title ICMJE | Detection of Thyrotrophin Receptor in Human Myometrium | ||||||||
| 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. |
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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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Biopsy of human myometrium |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Pregnant women (n=10) with a term ( > 37 weeks) baby, who are scheduled for elective caesarean section. |
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| Condition ICMJE | Thyrothrophin Receptor in Myometrium Tissue | ||||||||
| Intervention ICMJE | 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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| Study Group/Cohort (s) | Elective caesarean section
Population: ten pregnant women, scheduled for elective caesarean section with a term pregnancy ( > 37 weeks). Inclusion criteria
Exclusion criteria
Intervention: Procedure: Myometrial biopsy |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 10 | ||||||||
| Completion Date | January 2013 | ||||||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01348191 | ||||||||
| Other Study ID Numbers ICMJE | NL36261.060.11 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | S.Kuppens, Catharina Ziekenhuis Eindhoven | ||||||||
| Study Sponsor ICMJE | Catharina Ziekenhuis Eindhoven | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Catharina Ziekenhuis Eindhoven | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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