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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01922453
Other study ID # ritmo-HMO-CTIL
Secondary ID
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


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
See also
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Completed NCT00890474 - Moxibustion for Fetus in Breech Presentation Phase 3
Terminated NCT00119184 - Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version Phase 1
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Completed NCT00896311 - Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women N/A
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Recruiting NCT03827226 - Breech External Cephalic Version Intervention Trial
Completed NCT00813683 - Cephalic Version by Acupuncture for Breech Presentation N/A
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