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EBIS: The Eindhoven Breech Intervention Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516555
First Posted: August 15, 2007
Last Update Posted: March 19, 2013
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.
Collaborator:
University of Tilburg
Information provided by (Responsible Party):
S.Kuppens, Catharina Ziekenhuis Eindhoven
  Purpose

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
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)
Groups/Cohorts
A, 07, 001
Pregnant women at term with a baby in breech presentation who will have an external cephalic version.

  Eligibility

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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.
Criteria

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
Information from the National Library of Medicine

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


Locations
Netherlands
S.Kuppens
Eindhoven, Brabant, Netherlands, 5602 ZA
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
University of Tilburg
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: S.Kuppens, MD, Phd, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT00516555     History of Changes
Other Study ID Numbers: M06/1130
ABR Number 14584
First Submitted: August 13, 2007
First Posted: August 15, 2007
Last Update Posted: March 19, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases
Stress, Psychological
Hip Dislocation
Hip Dislocation, Congenital
Breech Presentation
Behavioral Symptoms
Joint Dislocations
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Obstetric Labor Complications
Pregnancy Complications