The Eindhoven Breech Intervention Study (EBIS)

Completed

• Conditions: External version of a foetus in breech position; 10010273

• Registration Number: NL-OMON30624
• Lead Sponsor: Maatschap gynaecologie Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 208

Inclusion Criteria

-Single pregnancy
-Gestation of 35 weeks or more
-Appropriate knowledge of the Dutch language
-Foetus in any of the 4 types of breech presentation:
• Frank breech presentation (highest incidence)
• Complete breech presentation (nonfrank breech presentation)
• Incomplete breech presentation
• Footling presentation

Exclusion Criteria

• Indications for caesarean delivery irrespective of presentation (eg, placenta previa)
• Previous caesarean section
• Previous abruptio placenta
• Multiple pregnancy
• Ruptured membranes
• Nonreassuring fetal monitoring test results
• Hyperextended fetal head
• Significant fetal or uterine anomaly
• Use of thyroid medication
• Maternal autoimmune diseases such as insulin-dependent diabetes mellitus or rheumatoid arthritis
• Intra-uterine growth retardation
• Oligo or anhydramnion
• Hiv-positive women

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: Main study parameter is the difference in mean<br /><br>FT4 (thyroid hormone) in women with successful ECV compared to those with no<br /><br>successful outcome of ECV. Moreover the independent relation between maternal<br /><br>mood state versus successful ECV will be assessed. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A secondary outcome is to evaluate whether neonatal thyroid parameters is<br /><br>associated with ECV.</p><br>