EBIS: The Eindhoven Breech Intervention Study

Ebis: The Eindhoven Breech Intervention Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00516555

Enrollment

250

Registered

2007-08-15

Start date

2007-10-31

Completion date

2012-10-31

Last updated

2013-03-19

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

Conditions

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

Keywords

Breech Presentation, External Cephalic version, Thyroid Function Tests

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Netherlands

Outcome results