Mindfulness-based Intervention Prior to External Cephalic Version

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.

Study Overview

• Status: Recruiting
• Conditions: External Cephalic Version; Breech Presentation in Pregnancy
• Intervention / Treatment: Behavioral: Short mindfulness-based intervention

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simone MI Kuppens, MD, PhD; Phone Number: 0031402399300; Email: simone.kuppens@catharinaziekenhuis.nl
• Study Contact Backup: Name: Lianne P Hulsbosch, PhD; Phone Number: 0134664213; Email: l.p.hulsbosch@tilburguniversity.edu

Study Locations

• Netherlands
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623 EJ
      • Recruiting
      • Catharina Hospital
      • Contact: Simone MI Kuppens, MD, PhD; Phone Number: 0031402399300; Email: simone.kuppens@catharinaziekenhuis.nl
      • Contact: Lianne P Hulsbosch, PhD; Phone Number: 0134664213; Email: l.p.hulsbosch@tilburguniversity.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant women (18+y).
• With a breech presenting fetus undergoing external cephalic version.
• Dutch/English-speaking or understanding Dutch/English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Care as usual
Experimental: Intervention group; Short mindfulness-based intervention (5 minutes) prior to the external cephalic version	Behavioral: Short mindfulness-based intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline mindfulness skills	Baseline mindfulness skills are assessed with the 15-item Three Facet Mindfulness Questionnaire Short Form (TFMQ-SF), consisting of the facets acting with awareness, non-judging and non-reacting. The total score ranges from 0 to 60, with higher scores indicating better mindfulness skills. The validity of the measure is established and indices of internal reliability were found to be adequate.	At baseline (i.e., in hospital, prior to intervention and external cephalic version)
Baseline depressive symptoms	Assessed with the 10-item Edinburgh Postnatal Depression Scale (EPDS). The EPDS is the most widely used self-rating scale to assess depressive symptoms in the perinatal period. The EPDS total score ranges from 0 to 30, with higher scores indicating more depressive symptoms. The questionnaire has been validated in Dutch postpartum women.	At baseline (i.e., in hospital, prior to intervention and external cephalic version)
Baseline fear of external cephalic version	Assessed with a visual analogue skill (VAS), by which participants indicate how anxious they feel about the upcoming external cephalic version. The scores range from 0 to 10, with higher scores indicating more anxiety about the upcoming external cephalic version.	At baseline (i.e., in hospital, prior to intervention and external cephalic version)
Post-intervention general questions	Three general questions about the information that women received during the external cephalic version, and the familiarity with mindfulness/yoga.	1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Post-intervention evaluation of the intervention	Four questions about how women perceived the intervention (intervention group only)	1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Tilburg University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; External cephalic version; Mindfulness intervention; Breech presentation
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Breech Presentation
• Other Study ID Numbers: W24.245

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No