Back to resultsMusic and Sounds for ECV (RITMO)
Primary Purpose
Breech Presentation, Vertex Presentation
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Music and Sound
Sponsored by
About this trial
This is an interventional treatment trial for Breech Presentation focused on measuring breech presentation, vertex presentation
Eligibility Criteria
Inclusion Criteria:
- pregnant women near term with breech presentation.
Exclusion Criteria:
- women with a contraindication for vaginal birth
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music and Sound
no music and sound
Arm Description
Music and Sound applied to maternal abdomen through a special device for pregnant women.
Outcomes
Primary Outcome Measures
vertex position
Secondary Outcome Measures
Full Information
NCT ID
NCT01922453
First Posted
August 11, 2013
Last Updated
August 11, 2013
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01922453
Brief Title
Music and Sounds for ECV
Acronym
RITMO
Official Title
Use of Music and Sounds for the External Cephalic Version of Breech Fetuses Near Term.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation, Vertex Presentation
Keywords
breech presentation, vertex presentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music and Sound
Arm Type
Experimental
Arm Description
Music and Sound applied to maternal abdomen through a special device for pregnant women.
Arm Title
no music and sound
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Music and Sound
Primary Outcome Measure Information:
Title
vertex position
Time Frame
3 days post intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant women near term with breech presentation.
Exclusion Criteria:
women with a contraindication for vaginal birth
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hagit Daum, MD
Phone
00 972 53 8246261
Email
dhagit@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagit Daum, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, MD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hagit Daum, MD
12. IPD Sharing Statement
Learn more about this trial
Music and Sounds for ECV
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