Music and Sounds for ECV

Breech Presentation Clinical Trial

— RITMO  

Official title:

Use of Music and Sounds for the External Cephalic Version of Breech Fetuses Near Term.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01922453
• Other study ID #: ritmo-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2013
• Last updated: August 11, 2013
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2013
• Source: Hadassah Medical Organization
• Contact: Hagit Daum, MD
• Phone: 00 972 53 8246261
• Email: dhagit[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This international study is looking to see if the addition of music and sound on the maternal abdomen encourages fetal position change from breech to vertex in near term women.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant women near term with breech presentation.

Exclusion Criteria:

• women with a contraindication for vaginal birth

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breech Presentation
• Vertex Presentation

Intervention

Other:
• Music and Sound

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vertex position		3 days post intervention	No