EBIS: The Eindhoven Breech Intervention Study

March 18, 2013 updated by: S.Kuppens, Catharina Ziekenhuis Eindhoven

Ebis: The Eindhoven Breech Intervention Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Brabant
      • Eindhoven, Brabant, Netherlands, 5602 ZA
        • S.Kuppens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with breech presentation at term in the region of Eindhoven, The Netherlands.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during external cephalic version

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at the time of delivery, at the age of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Collaborators

Tilburg University

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, Tilburg University
  • Study Chair: H. Vader, PhD, Prof, Maxima Medisch Centrum Veldhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 13, 2007

First Posted (Estimate)

August 15, 2007

Study Record Updates

Last Update Posted (Estimate)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06/1130
  • ABR Number 14584

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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