Thyrothrophin Receptor in Myometrium TissueNCT01348191
Detection of Thyrotrophin Receptor in Human Myometrium
An observational study of Thyrothrophin Receptor in Myometrium Tissue, run by Catharina Ziekenhuis Eindhoven at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyrothrophin Receptor in Myometrium Tissue
- What is being tested?
- Myometrial biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 4 sitesNetherlands
- Study dates
- Nov 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women (n=10) with a term ( > 37 weeks) baby, who are scheduled for elective caesarean section.
Who may be able to join
- Elective caesarean section
- Term pregnancy > 37 weeks
- Age > 18 years
Who cannot join
- Previous caesarean scar
- Gestational age < 37 weeks
- Maternal temperature > 37.8 degrees Celsius
- Meconium stained liquor
- Foetal distress
- Maternal diabetes
Show all 10Show fewer
- Seropositivity
- Use of thyroid medication
- Maternal thyroid disease
- Age < 18 years
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Catharina-hospital
Eindhoven, North Brabant, 5602 ZA
Eindhoven University of Technology
Eindhoven, North Brabant, 5612 AZ
Erasmus MC
Rotterdam, South Holland, 3015 GE
University of Tilburg
Tilburg, North Brabant, 5000 LE
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Myometrial biopsy
- Keywords
- Thyrotrophin, Pregnancy, Human myometrium, Relaxation, Contractility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myometrial biopsyProcedure or surgery
Also called Thyrotrophin, Myometrium, Relaxation, Contractility
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Myometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyrothrophin receptor
Immunodetection of Thyrothrophin receptor in myometrium tissue
Measured: three months
Secondary outcomes (1)
electropotentials in myometrium and relaxation and contractility
Investigation of relaxation and contractility of myometrium. Conductance of electropotentials of myometrium tissue
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thyrothrophin Receptor in Myometrium TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting PAMM, Tilburg University, Erasmus Medical Center, Eindhoven University of Technology
- Responsible party
- Principal investigator, S.Kuppens, Catharina Ziekenhuis Eindhoven
- Investigators
- simone M Kuppens, MD,PhD, Principal investigator, Catharina-ziekenhuis, Eindhoven, the NetherlandsVictor J Pop, MD,PhD,Prof, Study director, University of Tilburg, Department of Medical and Neuropsychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348191
- Sponsor's protocol ID
- NL36261.060.11
- Status last verified
- May 2013
- First submitted
- 4 May 2011
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14749667Oner 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.
PubMed 17653299Heemstra 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.
PubMed 18390987Peeters 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.
PubMed 17062880Kuppens 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.
PubMed 19832853Kooistra 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.
PubMed 20718770
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Thyrotrophin Receptor in Human Myometrium
- ClinicalTrials.gov ID
- NCT01348191
- Acronym / sponsor ID
- NL36261.060.11
- Keywords
- Thyrotrophin, Pregnancy, Human myometrium, Relaxation, Contractility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Stichting PAMM, Tilburg University, Erasmus Medical Center, Eindhoven University of Technology
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective caesarean section | – | Procedure: Myometrial biopsyPopulation: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women (n=10) with a term ( > 37 weeks) baby, who are scheduled for elective caesarean section.
Key inclusion criteria (3 listed)
- Elective caesarean section
- Term pregnancy > 37 weeks
- Age > 18 years
Key exclusion criteria (10 listed)
- Previous caesarean scar
- Gestational age < 37 weeks
- Maternal temperature > 37.8 degrees Celsius
- Meconium stained liquor
- Foetal distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myometrial biopsyAlso: Thyrotrophin, Myometrium, Relaxation, ContractilityAt 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. | Procedure or surgery | Elective caesarean section |
Primary outcome
Thyrothrophin receptor
Time frame: three months
Immunodetection of Thyrothrophin receptor in myometrium tissue
1 secondary outcome
electropotentials in myometrium and relaxation and contractility
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Background: PubMed 14749667Potter 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.
- Background: PubMed 17653299Oner 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.
- Background: PubMed 18390987Heemstra 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.
- Background: PubMed 17062880Peeters 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.
- Background: PubMed 19832853Kuppens 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.
- Background: PubMed 20718770Kooistra 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
simone M Kuppens, MD,PhD principal investigator
Catharina-ziekenhuis, Eindhoven, the Netherlands
Victor J Pop, MD,PhD,Prof study director
University of Tilburg, Department of Medical and Neuropsychology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyrothrophin Receptor in Myometrium Tissue, run by Catharina Ziekenhuis Eindhoven at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyrothrophin receptor (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348191, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2013.