Clinical trial NCT00516555: EBIS: The Eindhoven Breech Intervention Study
Official title: Ebis: The Eindhoven Breech Intervention Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breech Presentation
External Cephalic Version
Thyroid Hormones
Stress, Psychological
Congenital Hip Dysplasia
Keywords: Breech Presentation
External Cephalic version
Thyroid Function Tests
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Tilburg University
First posted: 2007-08-15
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with breech presentation at term in the region of Eindhoven, The Netherlands.

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.


Eligibility 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

Primary outcomes:
measure: The relation between maternal mood state and thyroid function during end gestation and successful external version of fetal breech position
timeFrame: during external cephalic version
Secondary outcomes:
measure: the relation between neonatal thyroid parameters at delivery and successful external version, the effect of successful version on hipdysplasia
timeFrame: at the time of delivery, at the age of 3 months
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: S.Kuppens
state: Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Simone M. Kuppens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis Eindhoven
name: Tom H. Hasaart, MD, PhD
role: STUDY_DIRECTOR
affiliation: Tilburg University
name: Victor J. Pop, MD, PhD, Prof
role: STUDY_CHAIR
affiliation: Maxima Medisch Centrum Veldhoven
name: H. Vader, PhD, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.