ClinicalTrials.gg
CompletedNCT00516555Updated Mar 19, 2013

EBIS: The Eindhoven Breech Intervention Study

An observational study in Breech Presentation, External Cephalic Version and Thyroid Hormones, sponsored by Catharina Ziekenhuis Eindhoven. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-19.

Sponsored by Catharina Ziekenhuis Eindhoven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breech Presentation
  • External Cephalic Version
  • Thyroid Hormones
  • Stress, Psychological
  • Congenital Hip Dysplasia

Keywords

  • Breech Presentation
  • External Cephalic version
  • Thyroid Function Tests
03

In context

Breech Presentation

41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.

This study's enrollment of 250 is above the median of 135 across 10 observational studies indexed under Breech Presentation.

Browse Breech Presentation studies →

Lead sponsor

Catharina Ziekenhuis Eindhoven is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 disease (such as insulin-dependant diabetes mellitus)
  • Intra-uterine growth retardation
  • Oligohydramnios
  • -positive women
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • A, 07, 001

    Pregnant women at term with a baby in breech presentation who will have an external cephalic version.

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • S.Kuppens
    Eindhoven, Brabant 5602 ZA, Netherlands
08

References and documents

Publications

  • 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. PubMed 29041923 ↗
  • 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. PubMed 24620740 ↗
  • 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. PubMed 21269431 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00516555
Lead sponsor
Catharina Ziekenhuis Eindhoven
Collaborators
Tilburg University
Responsible party
S.Kuppens (MD, Phd, Catharina Ziekenhuis Eindhoven) — Principal investigator
First posted
Aug 15, 2007
Start date
Oct 2007
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Mar 19, 2013

Study contacts

Simone M. Kuppens, MD
principal investigator · Catharina Ziekenhuis Eindhoven
Tom H. Hasaart, MD, PhD
study director · Catharina Ziekenhuis Eindhoven
Victor J. Pop, MD, PhD, Prof
study chair · Tilburg University
H. Vader, PhD, Prof
study chair · Maxima Medisch Centrum Veldhoven

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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