EBIS: The Eindhoven Breech Intervention Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00516555|
Recruitment Status : Completed
First Posted : August 15, 2007
Last Update Posted : March 19, 2013
The purpose of this study is to evaluate whether successful external cephalic version is associated with maternal thyroid function and mood state in pregnant women with breech presentation at term.
The relationship between successful external cephalic version and neonatal thyroid function will also be investigated.
A possible beneficial effect of successful external cephalic version on the development of congenital hip dysplasia will be evaluated.
|Condition or disease|
|Breech Presentation External Cephalic Version Thyroid Hormones Stress, Psychological Congenital Hip Dysplasia|
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Ebis: The Eindhoven Breech Intervention Study|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
A, 07, 001
Pregnant women at term with a baby in breech presentation who will have an external cephalic version.
- The relation between maternal mood state and thyroid function during end gestation and successful external version of fetal breech position [ Time Frame: during external cephalic version ]
- the relation between neonatal thyroid parameters at delivery and successful external version, the effect of successful version on hipdysplasia [ Time Frame: at the time of delivery, at the age of 3 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516555
|Eindhoven, Brabant, Netherlands, 5602 ZA|
|Principal Investigator:||Simone M. Kuppens, MD||Catharina Ziekenhuis Eindhoven|
|Study Director:||Tom H. Hasaart, MD, PhD||Catharina Ziekenhuis Eindhoven|
|Study Chair:||Victor J. Pop, MD, PhD, Prof||University of Tilburg|
|Study Chair:||H. Vader, PhD, Prof||Maxima Medisch Centrum Veldhoven|