Breech Presentation in PregnancyNCT06768060
Mindfulness-based Intervention Prior to External Cephalic Version
A study testing Short mindfulness-based intervention in people with Breech Presentation in Pregnancy and External Cephalic Version, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
The study is a randomized controlled trial examining the effectiveness of a short mindfulness-based intervention on the success rate of external cephalic version in pregnant women with breech presentation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breech Presentation in Pregnancy, External Cephalic Version
- What is being tested?
- Short mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Feb 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Pregnant women (18+y).
- With a breech presenting fetus undergoing external cephalic version.
- Dutch/English-speaking or understanding Dutch/English.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Hospital
Eindhoven, North Brabant, 5623 EJ
Simone MI Kuppens, MD, PhD, 0031402399300, simone.kuppens@catharinaziekenhuis.nl
Lianne P Hulsbosch, PhD, 0134664213, l.p.hulsbosch@tilburguniversity.edu
About this study
Official title: Preparing Mothers for External Cephalic Version: a Mindfulness-based Intervention for Pregnant Women With a Baby in Breech Presentation
The study is a randomized controlled trial examining the effectiveness of a short mindfulness-based intervention on the success rate of external cephalic version in pregnant women with breech presentation. It is hypothesized that this intervention will increase the ECV success rate and decrease the pain experienced after the ECV.
- Being tested
- Short mindfulness-based intervention
- Keywords
- Breech presentation, Pregnancy, External cephalic version, Mindfulness intervention
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short mindfulness-based interventionBehavioural
The intervention includes a short mindfulness-based intervention with a duration of 5 minutes. It involves a sitting mediation focused on breath adapted from the existing protocols of the Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT). The intervention is audio-guided and will be delivered via headphones.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Short mindfulness-based intervention (5 minutes) prior to the external cephalic version Receives: Behavioral: Short mindfulness-based intervention |
| Control group | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention external cephalic version success rate
The success rate of the external cephalic versions (successful/not successful) will be compared between the intervention and control group.
Measured: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Secondary outcomes (2)
Post-intervention pain perception
The pain experienced during the external cephalic version will be assessed with a visual analogue scale (VAS). The mean/median VAS scores will be compared between the intervention and control group. The scores range between 0 and 10, with a higher score indicating more experienced pain.
Measured: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Post-intervention comfort
Comfort during the external cephalic version will be assessed with a visual analogue scale (VAS). The mean/median VAS scores will be compared between the intervention and control group. The scores range between 0 and 10, with a higher score indicating more comfort.
Measured: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start27 Feb 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech Presentation in PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization stratified for parity.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University
- Responsible party
- Principal investigator, Simone Kuppens, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768060
- Sponsor's protocol ID
- W24.245
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Mothers for External Cephalic Version: a Mindfulness-based Intervention for Pregnant Women With a Baby in Breech Presentation
- ClinicalTrials.gov ID
- NCT06768060
- Acronym / sponsor ID
- W24.245
- Keywords
- Breech presentation, Pregnancy, External cephalic version, Mindfulness intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Tilburg University
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 10 Jan 2025 (actual)
- 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 study is a randomized controlled trial examining the effectiveness of a short mindfulness-based intervention on the success rate of external cephalic version in pregnant women with breech presentation. It is hypothesized that this intervention will increase the ECV success rate and decrease the pain experienced after the ECV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomization stratified for parity.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Short mindfulness-based interventionShort mindfulness-based intervention (5 minutes) prior to the external cephalic version |
| Control group | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women (18+y).
- With a breech presenting fetus undergoing external cephalic version.
- Dutch/English-speaking or understanding Dutch/English.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short mindfulness-based interventionThe intervention includes a short mindfulness-based intervention with a duration of 5 minutes. It involves a sitting mediation focused on breath adapted from the existing protocols of the Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT). The intervention is audio-guided and will be delivered via headphones. | Behavioural | Intervention group |
Primary outcome
Post-intervention external cephalic version success rate
Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
The success rate of the external cephalic versions (successful/not successful) will be compared between the intervention and control group.
2 secondary outcomes
Post-intervention pain perception
Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Post-intervention comfort
Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Discourse on the Mother's Decision Regarding the Mode of Delivery in Cases of Breech Presentation
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Not yet recruitingObservational study
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short mindfulness-based intervention in people with Breech Presentation in Pregnancy 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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone MI Kuppens, MD, PhD (0031402399300, simone.kuppens@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention external cephalic version success rate (time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.