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. Identifier: NCT00516555
Recruitment Status : Completed
First Posted : August 15, 2007
Last Update Posted : March 19, 2013
University of Tilburg
Information provided by (Responsible Party):
S.Kuppens, Catharina Ziekenhuis Eindhoven

August 13, 2007
August 15, 2007
March 19, 2013
October 2007
October 2012   (Final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00516555 on Archive Site
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 ]
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EBIS: The Eindhoven Breech Intervention Study
Ebis: The Eindhoven Breech Intervention Study

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.

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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Blood samples for thyroid hormone status (Tsh, Ft4, anti-TPO)
Non-Probability Sample
Pregnant women with breech presentation at term in the region of Eindhoven, The Netherlands.
  • Breech Presentation
  • External Cephalic Version
  • Thyroid Hormones
  • Stress, Psychological
  • Congenital Hip Dysplasia
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A, 07, 001
Pregnant women at term with a baby in breech presentation who will have an external cephalic version.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Single pregnancy
  • Gestation of 35 weeks or more
  • Appropriate knowledge of the Dutch language
  • Fetus in any of the 4 types of breech presentation: frank breech, complete breech, incomplete breech or footling presentation

Exclusion Criteria:

  • Previous caesarean section
  • Indication for caesarean delivery irrespective of presentation
  • Previous abruptio placenta
  • Multiple pregnancy
  • Ruptured membranes
  • Non-reassuring fetal monitoring tests results
  • Hyperextended fetal head
  • Significant uterine or fetal anomaly
  • Use of thyroid medication
  • Maternal autoimmune disease (such as insulin-dependant diabetes mellitus)
  • Intra-uterine growth retardation
  • Oligohydramnios
  • HIV-positive women
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
ABR Number 14584
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S.Kuppens, Catharina Ziekenhuis Eindhoven
Catharina Ziekenhuis Eindhoven
University of Tilburg
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
Catharina Ziekenhuis Eindhoven
March 2013