Breech PresentationRITMONCT01922453
Music and Sounds for ECV
A study testing Music and Sound in people with Breech Presentation and Vertex Presentation, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breech Presentation, Vertex Presentation
- What is being tested?
- Music and Sound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women near term with breech presentation.
Who cannot join
- women with a contraindication for vaginal birth
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem
Hadas Lemberg, MD, 00 972 2 6777572, lhadas@hadassah.org.il
Hagit Daum, MD
About this study
Official title: Use of Music and Sounds for the External Cephalic Version of Breech Fetuses Near Term.
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.
- Conditions
- Breech Presentation, Vertex Presentation
- Being tested
- Music and Sound
- Keywords
- breech presentation, vertex presentation
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and SoundOther
| Study group | Role | What they receive |
|---|---|---|
| Music and Sound | Experimental | Music and Sound applied to maternal abdomen through a special device for pregnant women. Receives: Other: Music and Sound |
| no music and sound | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
vertex position
Measured: 3 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hagit Daum, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922453
- Sponsor's protocol ID
- ritmo-HMO-CTIL
- Acronym
- RITMO
- Status last verified
- Aug 2013
- First submitted
- 11 Aug 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Music and Sounds for the External Cephalic Version of Breech Fetuses Near Term.
- ClinicalTrials.gov ID
- NCT01922453
- Acronym / sponsor ID
- RITMO / ritmo-HMO-CTIL
- Conditions
- Breech Presentation, Vertex Presentation
- Keywords
- breech presentation, vertex presentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music and Sound | Experimental | Other: Music and SoundMusic and Sound applied to maternal abdomen through a special device for pregnant women. |
| no music and sound | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women near term with breech presentation.
Key exclusion criteria (1 listed)
- women with a contraindication for vaginal birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music and Sound | Other | Music and Sound |
Primary outcome
vertex position
Time frame: 3 days post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
Related trials for Breech Presentation
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Breech Presentation in Pregnancy, External Cephalic Version
RecruitingObservational study
Discourse on the Mother's Decision Regarding the Mode of Delivery in Cases of Breech Presentation
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RecruitingObservational study
Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle
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Not yet recruitingObservational study
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagit Daum, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Sound in people with Breech Presentation and Vertex Presentation, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagit Daum, MD (00 972 53 8246261, dhagit@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertex position (time frame: 3 days post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.