PregnancySUCINCT02283606
Sonoelastography of the Uterine Cervix Before Induction of Labor
An observational study of Pregnancy, run by Meir Medical Center.
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. 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?
- Accuvix SnonAce UGEO
- Type of treatment
- Medical device
- How many people
- 40 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: 20-44 years old pregnant patients
Who may be able to join
- pregnant patients before induction of labor
Who cannot join
- pregnant patients undergoing caesaren section following induction of labor not in active labor
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Conditions
- Pregnancy
- Being tested
- Accuvix SnonAce UGEO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuvix SnonAce UGEODevice
vaginal ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity of the uterine cervix as measured sonoelastographically in successful and failed inductions of labor
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 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
- 40 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
- NCT02283606
- Sponsor's protocol ID
- 0154-14-MMC
- Acronym
- SUCI
- 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
- Sonoelastography of the Uterine Cervix Before Induction of Labor
- ClinicalTrials.gov ID
- NCT02283606
- Acronym / sponsor ID
- SUCI / 0154-14-MMC
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 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
- 5 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.
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.
Detailed 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.
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
- 20-44 years old pregnant patients
Key inclusion criteria (1 listed)
- pregnant patients before induction of labor
Key exclusion criteria (1 listed)
- pregnant patients undergoing caesaren section following induction of labor not in active labor
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 |
|---|---|---|
| Accuvix SnonAce UGEOvaginal ultrasonography | Device | – |
Primary outcome
Elasticity of the uterine cervix as measured sonoelastographically in successful and failed inductions of labor
Time frame: 48-72 hours
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.
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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 (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?
Elasticity of the uterine cervix as measured sonoelastographically in successful and failed inductions of labor (time frame: 48-72 hours). 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.