Mindfulness intervention to improve breech baby turning success
Preparing Mothers for External Cephalic Version: a Mindfulness-based Intervention for Pregnant Women With a Baby in Breech Presentation
This study tests if a mindfulness program can help pregnant women with breech babies have a better chance of turning their babies and feel less pain after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Catharina Ziekenhuis Eindhoven Academic / other |
| Locations | 1 site (Eindhoven, North Brabant) |
| Trial ID | NCT06768060 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a short mindfulness-based intervention for pregnant women with a breech presentation who are undergoing external cephalic version (ECV). The study aims to determine if this intervention can enhance the success rate of ECV and reduce post-procedure pain. Participants will be randomly assigned to receive either the mindfulness intervention or standard care. The trial focuses on the psychological and physical aspects of the ECV process to improve outcomes for both mothers and babies.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older with a breech presenting fetus who are planning to undergo external cephalic version.
Not a fit: Patients who are not pregnant or do not have a breech presentation will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to higher success rates for turning breech babies and less pain for mothers during the procedure.
How similar studies have performed: While mindfulness interventions have shown promise in various medical contexts, this specific application in the context of external cephalic version is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women (18+y). * With a breech presenting fetus undergoing external cephalic version. * Dutch/English-speaking or understanding Dutch/English.
Where this trial is running
Eindhoven, North Brabant
- Catharina Hospital — Eindhoven, North Brabant, Netherlands (Recruiting)
Study contacts
- Study coordinator: Simone MI Kuppens, MD, PhD
- Email: simone.kuppens@catharinaziekenhuis.nl
- Phone: 0031402399300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.