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The Eindhoven Breech Intervention Study (EBIS)

The Eindhoven Breech Intervention Study (EBIS) - Ebis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30624
Enrollment
208
Registered
2007-03-15
Start date
2007-10-16
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

External version of a foetus in breech position

Interventions

None listed

Sponsors

Maatschap gynaecologie Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
A secondary outcome is to evaluate whether neonatal thyroid parameters is associated with ECV.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)