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EBIS: The Eindhoven Breech Intervention Study

This study has been completed.
University of Tilburg
Information provided by (Responsible Party):
S.Kuppens, Catharina Ziekenhuis Eindhoven Identifier:
First received: August 13, 2007
Last updated: March 18, 2013
Last verified: March 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.

Breech Presentation External Cephalic Version Thyroid Hormones Stress, Psychological Congenital Hip Dysplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ebis: The Eindhoven Breech Intervention Study

Resource links provided by NLM:

Further study details as provided by S.Kuppens, Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Blood samples for thyroid hormone status (Tsh, Ft4, anti-TPO)

Enrollment: 250
Study Start Date: October 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
A, 07, 001
Pregnant women at term with a baby in breech presentation who will have an external cephalic version.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with breech presentation at term in the region of Eindhoven, The Netherlands.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00516555

Eindhoven, Brabant, Netherlands, 5602 ZA
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: S.Kuppens, MD, Phd, Catharina Ziekenhuis Eindhoven Identifier: NCT00516555     History of Changes
Other Study ID Numbers: M06/1130
ABR Number 14584
Study First Received: August 13, 2007
Last Updated: March 18, 2013

Keywords provided by S.Kuppens, Catharina Ziekenhuis Eindhoven:
Breech Presentation
External Cephalic version
Thyroid Function Tests

Additional relevant MeSH terms:
Stress, Psychological
Hip Dislocation
Hip Dislocation, Congenital
Breech Presentation
Behavioral Symptoms
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Obstetric Labor Complications
Pregnancy Complications processed this record on September 18, 2017