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NCT02283606 Clinical Trial

Sonoelastography of the Uterine Cervix Before Induction of Labor

Pregnancy Clinical Trial

— SUCI  

Official title:
Sonoelastography of the Uterine Cervix Before Induction of Labor

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02283606
Other study ID # 0154-14-MMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 26, 2014
Last updated September 22, 2015
Start date November 2015
Est. completion date November 2016

Study information
Verified date September 2015
Source Meir Medical Center
Contact Rami Aviram
Phone 972544944862
Email rami.aviram@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The investigators aim to measure sonoelastographically the elasticity of the uterine cervix in pregnant patients at term before induction of labor and compare between patients with successful and failed inductions.

Description:

Softening of the uterine cervix in pregnant patients at term causes changes in its elasticity.these changes may affect success or failure in induction of labor.The elasticity of the uterine cervix is usually evaluated clinically and subjectively by vaginal examination (bishop's score) which is not very predictive.We aim to measure the elasticity quantitatively and objectively.The difference in strain, in the area of the internal os , is often illustrated by a color map, where low stiffness (soft tissue) is indicated in red, middle stiffness is in green and high stiffness (hard tissue) is in blue.The color maps will be compared between patients with successful and failed inductions.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 44 Years
Eligibility Inclusion Criteria:

- pregnant patients before induction of labor

Exclusion Criteria:

- pregnant patients undergoing caesaren section following induction of labor not in active labor

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Accuvix SnonAce UGEO
vaginal ultrasonography

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Elasticity of the uterine cervix as measured sonoelastographically in successful and failed inductions of labor 48-72 hours Yes
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