EBIS: The Eindhoven Breech Intervention Study

Catharina Ziekenhuis Eindhoven250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: during external cephalic version

Secondary Outcomes

the relation between neonatal thyroid parameters at delivery and successful external version, the effect of successful version on hipdysplasia

Time frame: at the time of delivery, at the age of 3 months