NCT02288689

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 .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

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

October 26, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

October 26, 2014

Last Update Submit

September 22, 2015

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Acuuvix SonoAce UGEODEVICE

Ultrasonographic vaginal examination

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant patients 20-44 years old at term

You may qualify if:

  • Pregnant patients at term

You may not qualify if:

  • Various pregnancy complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Rami Aviram, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rami Aviram, MD

CONTACT

972544944862rami.aviram@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 26, 2014

First Posted

November 11, 2014

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 23, 2015

Record last verified: 2015-09