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Completed

NCT Number: NCT00516555

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.

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Key information

Conditions

Breech Presentation Behavior Behavioral Symptoms Congenital Abnormalities Congenital Hip Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip External Cephalic Version Female Urogenital Diseases and Pregnancy Complications Hip Dislocation, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Obstetric Labor Complications Pregnancy Complications Stress, Psychological Thyroid Hormones Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

S.Kuppens

Eindhoven, North Brabant, 5602 ZA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Tilburg University

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 15, 2007
Registry last updated
Mar 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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