EBIS: The Eindhoven Breech Intervention Study

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
A, 07, 001; Pregnant women at term with a baby in breech presentation who will have an external cephalic version.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. 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)

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kuppens SM, Smailbegovic I, Houterman S, de Leeuw I, Hasaart TH. Fetal heart rate abnormalities during and after external cephalic version: Which fetuses are at risk and how are they delivered? BMC Pregnancy Childbirth. 2017 Oct 17;17(1):363. doi: 10.1186/s12884-017-1547-6.

Ciliacus E, van der Zalm M, Truijens SE, Hasaart TH, Pop VJ, Kuppens SM. Fear for external cephalic version and depression: predictors of successful external cephalic version for breech presentation at term? BMC Pregnancy Childbirth. 2014 Mar 12;14:101. doi: 10.1186/1471-2393-14-101.

Kuppens SM, Kooistra L, Hasaart TH, van der Donk RW, Vader HL, Oei GS, Pop VJ. Maternal thyroid function and the outcome of external cephalic version: a prospective cohort study. BMC Pregnancy Childbirth. 2011 Jan 26;11:10. doi: 10.1186/1471-2393-11-10.

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
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