CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Myometrial biopsyprocedure
Likely dose
Not stated in record
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Search/NCT01348191
NCT01348191N/ACompleted

Detection of Thyrotrophin Receptor in Human Myometrium

Catharina Ziekenhuis Eindhoven·observational·Posted May 5, 2011·Updated May 24, 2013

In Brief

An observational study evaluating Myometrial biopsy for Thyrothrophin Receptor in Myometrium Tissue. Completed, enrolled 10 participants across 4 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 5, 2011
Enrollment StartNov 1, 2011
Primary CompletionSep 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.2 years ago

Interventions

Myometrial biopsyprocedure

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.