EBIS: The Eindhoven Breech Intervention Study

This study has been completed.
Sponsor:
Collaborator:
University of Tilburg
Information provided by (Responsible Party):
S.Kuppens, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT00516555
First received: August 13, 2007
Last updated: March 18, 2013
Last verified: March 2013
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Catharina Ziekenhuis Eindhoven

Additional 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
Study First Received: August 13, 2007
Last Updated: March 18, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Catharina Ziekenhuis Eindhoven:
Breech Presentation
External Cephalic version
Thyroid Function Tests

Additional relevant MeSH terms:
Hip Dislocation, Congenital
Breech Presentation
Stress, Psychological
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Obstetric Labor Complications
Pregnancy Complications
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 01, 2014