EBIS: The Eindhoven Breech Intervention Study

Stress, Psychological Clinical Trial

Official title:

Ebis: The Eindhoven Breech Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516555
• Other study ID #: M06/1130
• Secondary ID: ABR Number 14584
• Status: Completed
• Phase: N/A
• First received: August 13, 2007
• Last updated: March 18, 2013
• Start date: October 2007
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Netherlands	S.Kuppens	Eindhoven	Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	University of Tilburg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relation between maternal mood state and thyroid function during end gestation and successful external version of fetal breech position		during external cephalic version	No
Secondary	the relation between neonatal thyroid parameters at delivery and successful external version, the effect of successful version on hipdysplasia		at the time of delivery, at the age of 3 months	No