NCT01922453

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

August 11, 2013

Last Update Submit

August 11, 2013

Conditions

Breech PresentationVertex Presentation

Keywords

breech presentationvertex presentation

Outcome Measures

Primary Outcomes (1)

  • vertex position

    3 days post intervention

Study Arms (2)

Music and Sound

EXPERIMENTAL

Music and Sound applied to maternal abdomen through a special device for pregnant women.

Other: Music and Sound

no music and sound

NO INTERVENTION

Interventions

Music and SoundOTHER
Music and Sound

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women near term with breech presentation.

You may not qualify if:

  • women with a contraindication for vaginal birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Breech Presentation

Interventions

Sound

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Radiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Hagit Daum, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagit Daum, MD

CONTACT

00 972 53 8246261dhagit@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2013

First Posted

August 14, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

IL(1)