PregnancyEUCNCT02288689
Clinical and Sonoelasographic Evaluation of the Elasticity of the Uterine Cervix in Pregnant Patients at Term
An observational study of Pregnancy, run by Meir Medical Center.
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 . Read more about this study
- Who is it for?
- Ages 20 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Acuuvix SonoAce UGEO
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant patients 20-44 years old at term
Who may be able to join
- Pregnant patients at term
Who cannot join
- Various pregnancy complications
Trial locations and contacts
No sites are listed yet.
About this study
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 .
Read the 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
- Being tested
- Acuuvix SonoAce UGEO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuuvix SonoAce UGEODevice
Ultrasonographic vaginal examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess elasticity of uterine cervix through comparison of sonoelastographic evaluation and manual vaginal examination [Bishop Score] in pregnant patients at term
Measured: at time of the manual vaginal examination and participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Aviram, Meir Medical Center
- Investigators
- Rami Aviram, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288689
- Sponsor's protocol ID
- 0180-14-MMC
- Acronym
- EUC
- Status last verified
- Sep 2015
- First submitted
- 26 Oct 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Sonoelasographic Evaluation of the Elasticity of the Uterine Cervix in Pregnant Patients at Term
- ClinicalTrials.gov ID
- NCT02288689
- Acronym / sponsor ID
- EUC / 0180-14-MMC
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant patients 20-44 years old at term
Key inclusion criteria (1 listed)
- Pregnant patients at term
Key exclusion criteria (1 listed)
- Various pregnancy complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acuuvix SonoAce UGEOUltrasonographic vaginal examination | Device | – |
Primary outcome
Assess elasticity of uterine cervix through comparison of sonoelastographic evaluation and manual vaginal examination [Bishop Score] in pregnant patients at term
Time frame: at time of the manual vaginal examination and participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rami Aviram, MD principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rami Aviram, MD (972544944862, rami.aviram@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess elasticity of uterine cervix through comparison of sonoelastographic evaluation and manual vaginal examination [Bishop Score] in pregnant patients at term (time frame: at time of the manual vaginal examination and participants will be followed for the duration of hospital stay, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.