Stress, Psychological Clinical Trial
Official title:
Ebis: The Eindhoven Breech Intervention Study
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | S.Kuppens | Eindhoven | Brabant |
Lead Sponsor | Collaborator |
---|---|
Catharina Ziekenhuis Eindhoven | University of Tilburg |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The relation between maternal mood state and thyroid function during end gestation and successful external version of fetal breech position | during external cephalic version | No | |
Secondary | 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 | No |
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