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

NCT ID: NCT02288689

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-11-30

Brief 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 .

Detailed 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.

Conditions

Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Acuuvix SonoAce UGEO

Ultrasonographic vaginal examination

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Pregnant patients at term

Exclusion Criteria

• Various pregnancy complications

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rami Aviram

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rami Aviram, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Central Contacts

Rami Aviram, MD

Role: CONTACT

rami.aviram@clalit.org.il

972544944862

Other Identifiers

0180-14-MMC

Identifier Type: -

Identifier Source: org_study_id