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NCT02288689 Clinical Trial

Clinical and Sonoelasographic Evaluation of the Elasticity of the Uterine Cervix in Pregnant Patients at Term

Pregnancy Clinical Trial

— EUC  

Official title:
Clinical and Sonoelasographic Evaluation of the Elasticity of the Uterine Cervix in Pregnant Patients at Term

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02288689
Other study ID # 0180-14-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, MD
Phone 972544944862
Email rami.aviram@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

In this study the investigators aim to compare the cervical dilation time in pregnant patients at term who had clinical evaluation of the cervical consistency with patients who had also quantitative measurement of the cervical elasticity in .

Description:

Softening of the uterine cervix in pregnant patients at term is usually evaluated clinically by subjective vaginal manual examination (Bishop's score).One of the variables of the score is cervical consistency which is considered important factor.The cervical consistency is described as soft,medium or stiff.However, the digital assessment of consistency is subjective and less reproducible.The Bishop's score also gives information about expected duration of labor after induction. The consistency of the uterine cervix can also be evaluated objectively sonoelastographically by measuring the cervical elasticity.This is 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.In this study we aim to compare the cervical dilation time between the clinical evaluation of the cervical consistency and the quantitative measurement of the cervical elasticity in pregnant patients at term.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
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 at term

Exclusion Criteria:

- Various pregnancy complications

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Acuuvix SonoAce UGEO
Ultrasonographic vaginal examination

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Assess elasticity of uterine cervix through comparison of sonoelastographic evaluation and manual vaginal examination [Bishop Score] in pregnant patients at term at time of the manual vaginal examination and participants will be followed for the duration of hospital stay, an expected average of 5 weeks Yes
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