Breech PresentationNCT00516555
EBIS: The Eindhoven Breech Intervention Study
An observational study of Breech Presentation and External Cephalic Version, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breech Presentation, External Cephalic Version, Thyroid Hormones
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2007to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with breech presentation at term in the region of Eindhoven, The Netherlands.
Who may be able to join
- 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
Who cannot join
- Previous caesarean section
- Indication for caesarean delivery irrespective of presentation
- Previous abruptio placenta
- Multiple pregnancy
- Ruptured membranes
- Non-reassuring fetal monitoring tests results
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Breech Presentation, External Cephalic Version, Thyroid Hormones, Stress, Psychological, Congenital Hip Dysplasia
- Keywords
- Breech Presentation, External Cephalic version, Thyroid Function Tests
- Medical subject headings
- Breech Presentation, Stress, Psychological, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A, 07, 001 | Pregnant women at term with a baby in breech presentation who will have an external cephalic version. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relation between maternal mood state and thyroid function during end gestation and successful external version of fetal breech position
Measured: 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
Measured: at the time of delivery, at the age of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University
- Responsible party
- Principal investigator, S.Kuppens, Catharina Ziekenhuis Eindhoven
- Investigators
- Simone M. Kuppens, MD, Principal investigator, Catharina Ziekenhuis EindhovenTom H. Hasaart, MD, PhD, Study director, Catharina Ziekenhuis EindhovenVictor J. Pop, MD, PhD, Prof, Study chair, Tilburg UniversityH. Vader, PhD, Prof, Study chair, Maxima Medisch Centrum Veldhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516555
- Sponsor's protocol ID
- M06/1130
- Other IDs
- ABR Number 14584
- Status last verified
- Mar 2013
- First submitted
- 13 Aug 2007
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29041923Ciliacus 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.
PubMed 24620740Kuppens 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.
PubMed 21269431
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ebis: The Eindhoven Breech Intervention Study
- ClinicalTrials.gov ID
- NCT00516555
- Acronym / sponsor ID
- M06/1130
- Conditions
- Breech Presentation, External Cephalic Version, Thyroid Hormones, Stress, Psychological, Congenital Hip Dysplasia
- Keywords
- Breech Presentation, External Cephalic version, Thyroid Function Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Tilburg University
- Study start
- Oct 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, 07, 001 | – | –Pregnant women at term with a baby in breech presentation who will have an external cephalic version. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with breech presentation at term in the region of Eindhoven, The Netherlands.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Previous caesarean section
- Indication for caesarean delivery irrespective of presentation
- Previous abruptio placenta
- Multiple pregnancy
- Ruptured membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
- Derived from this study: PubMed 29041923Kuppens 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.
- Derived from this study: PubMed 24620740Ciliacus 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.
- Derived from this study: PubMed 21269431Kuppens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone M. Kuppens, MD principal investigator
Catharina Ziekenhuis Eindhoven
Tom H. Hasaart, MD, PhD study director
Catharina Ziekenhuis Eindhoven
Victor J. Pop, MD, PhD, Prof study chair
Tilburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breech Presentation and External Cephalic Version, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00516555, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.