Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2007-10-31
2012-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A, 07, 001
Pregnant women at term with a baby in breech presentation who will have an external cephalic version.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Tilburg University
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
Responsible Party
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S.Kuppens
MD, Phd
Principal Investigators
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Simone M. Kuppens, MD
Role: PRINCIPAL_INVESTIGATOR
Catharina Ziekenhuis Eindhoven
Tom H. Hasaart, MD, PhD
Role: STUDY_DIRECTOR
Catharina Ziekenhuis Eindhoven
Victor J. Pop, MD, PhD, Prof
Role: STUDY_CHAIR
Tilburg University
H. Vader, PhD, Prof
Role: STUDY_CHAIR
Maxima Medisch Centrum Veldhoven
Locations
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S.Kuppens
Eindhoven, North Brabant, Netherlands
Countries
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References
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Kuppens SM, Smailbegovic I, Houterman S, de Leeuw I, Hasaart TH. Fetal heart rate abnormalities during and after external cephalic version: Which fetuses are at risk and how are they delivered? BMC Pregnancy Childbirth. 2017 Oct 17;17(1):363. doi: 10.1186/s12884-017-1547-6.
Ciliacus E, van der Zalm M, Truijens SE, Hasaart TH, Pop VJ, Kuppens SM. Fear for external cephalic version and depression: predictors of successful external cephalic version for breech presentation at term? BMC Pregnancy Childbirth. 2014 Mar 12;14:101. doi: 10.1186/1471-2393-14-101.
Kuppens SM, Kooistra L, Hasaart TH, van der Donk RW, Vader HL, Oei GS, Pop VJ. Maternal thyroid function and the outcome of external cephalic version: a prospective cohort study. BMC Pregnancy Childbirth. 2011 Jan 26;11:10. doi: 10.1186/1471-2393-11-10.
Other Identifiers
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ABR Number 14584
Identifier Type: -
Identifier Source: secondary_id
M06/1130
Identifier Type: -
Identifier Source: org_study_id
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