NCT00516555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

5 years

First QC Date

August 13, 2007

Last Update Submit

March 18, 2013

Conditions

Breech PresentationExternal Cephalic VersionThyroid HormonesStress, PsychologicalCongenital Hip Dysplasia

Keywords

Breech PresentationExternal Cephalic versionThyroid Function Tests

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

A, 07, 001

Pregnant women at term with a baby in breech presentation who will have an external cephalic version.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with breech presentation at term in the region of Eindhoven, The Netherlands.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.Kuppens

Eindhoven, North Brabant, 5602 ZA, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 29041923DERIVED

  • 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.

    PMID: 24620740DERIVED

  • 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.

    PMID: 21269431DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for thyroid hormone status (Tsh, Ft4, anti-TPO)

MeSH Terms

Conditions

Breech PresentationStress, PsychologicalHip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavioral SymptomsBehaviorDevelopmental Dysplasia of the HipMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Simone M. Kuppens, MD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

  • Tom H. Hasaart, MD, PhD

    Catharina Ziekenhuis Eindhoven

    STUDY DIRECTOR

  • Victor J. Pop, MD, PhD, Prof

    Tilburg University

    STUDY CHAIR

  • H. Vader, PhD, Prof

    Maxima Medisch Centrum Veldhoven

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Phd

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 15, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

NL(1)