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EBIS: The Eindhoven Breech Intervention Study

This study has been completed.
Sponsor:
Collaborator:
University of Tilburg
Information provided by (Responsible Party):
S.Kuppens, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT00516555
First received: August 13, 2007
Last updated: March 18, 2013
Last verified: March 2013

August 13, 2007
March 18, 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00516555 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00516555
M06/1130, ABR Number 14584
Yes
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP