EBIS: The Eindhoven Breech Intervention Study

Completed

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

• Registration Number: NCT00516555
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-15
• Study Start: 2007-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relation between maternal mood state and thyroid function during end gestation and successful external version of fetal breech position	during external cephalic version

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

S.Kuppens; 🇳🇱 Eindhoven, Brabant, Netherlands