EBIS: The Eindhoven Breech Intervention Study
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ClinicalTrials.gov Identifier: NCT00516555 |
Recruitment Status
:
Completed
First Posted
: August 15, 2007
Last Update Posted
: March 19, 2013
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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 |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |

Group/Cohort |
---|
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

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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 |
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

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
Netherlands | |
S.Kuppens | |
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 |
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 Posted: | August 15, 2007 Key Record Dates |
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:
Stress, Psychological Hip Dislocation Hip Dislocation, Congenital Breech Presentation Behavioral Symptoms Joint Dislocations Bone Diseases |
Musculoskeletal Diseases Wounds and Injuries Hip Injuries Musculoskeletal Abnormalities Congenital Abnormalities Obstetric Labor Complications Pregnancy Complications |