Cervix; PregnancyNCT05200117
Pregnolia System Intra-observer Variability
An observational study of Cervix; Pregnancy and Cervical Stiffness, run by Pregnolia AG at 1 site in Switzerland.
Trial summary
The Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix; Pregnancy, Cervical Stiffness
- What is being tested?
- Pregnolia System
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jan 2022to 17 Dec 2023
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women at gestational ages between 14+0 and 36+6 weeks.
Who may be able to join
- Informed Consent signed by the subject
- Pregnant woman
- Singleton pregnancy
- 18 years or older
- Nulliparous cohort: nulliparous pregnant woman
- Multiparous cohort: multiparous pregnant woman
Who cannot join
- Lack of informed consent
- Placenta praevia totalis with haemorrhage (irrespective of severity)
- Severe vaginal bleeding
- Rupture of membranes before 34 weeks (to be excluded with pH test)
- Visible tissue scarring at 12 o'clock position on cervix
- Light bleeding (if the bleeding can be stopped, it is no longer an exclusion criterion)
- Cervical dilation ≥ 3 cm
- Cerclage or pessary in place
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System
The Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user.
This project aims to study intra-observer variability of the Pregnolia System in pregnant women in the clinical setting.
Furthermore, a same day repeated measurement serves to investigate the time period needed to recover the pre-measurement stiffness state due to viscoelasticity of the cervical tissue.
- Conditions
- Cervix; Pregnancy, Cervical Stiffness
- Being tested
- Pregnolia System
- Keywords
- Cervical Stiffness, Intra-Observer Variability, Pregnolia System, Cervical Stiffness Index, CSI, Stiffness measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnolia SystemDevice
The cervical stiffness is measured with the Pregnolia System three times over a two-day period.
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous cohort | Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages. Receives: Device: Pregnolia System | |
| Multiparous cohort | Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages. Receives: Device: Pregnolia System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Stiffness Index
Cervical Stiffness Index (CSI, in mbar) measured repeatedly after 2 to 4 hours and approximately 24 hours at three different locations on the uterine cervix.
Measured: Measurements between 14+0 and 41+6 weeks gestational weeks
Secondary outcomes (3)
Cervical Stiffness Index (CSI, in mbar)
Measured: Measurements between 14+0 and 41+6 weeks gestational weeks
Elapsed time between
The elapsed time between when the subject got out of bed until the measurements were taken
Measured: Measurements between 14+0 and 41+6 weeks gestational weeks
Device-related adverse events
Device-related adverse events (incidence, severity, and seriousness)
Measured: Measurements between 14+0 and 41+6 weeks gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start12 Jan 2022
- Primary completion17 Dec 2023
- Study completion17 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix; 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pregnolia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200117
- Sponsor's protocol ID
- F-405-11 vs 3.0, 2023-07-21
- Status last verified
- Mar 2024
- First submitted
- 6 Jan 2022
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System
- ClinicalTrials.gov ID
- NCT05200117
- Acronym / sponsor ID
- F-405-11 vs 3.0, 2023-07-21
- Conditions
- Cervix; Pregnancy, Cervical Stiffness
- Keywords
- Cervical Stiffness, Intra-Observer Variability, Pregnolia System, Cervical Stiffness Index, CSI, Stiffness measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pregnolia AGIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 17 Dec 2023 (actual)
- Study completion
- 17 Dec 2023 (actual)
- First posted
- 20 Jan 2022 (actual)
- 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 Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user.
This project aims to study intra-observer variability of the Pregnolia System in pregnant women in the clinical setting.
Furthermore, a same day repeated measurement serves to investigate the time period needed to recover the pre-measurement stiffness state due to viscoelasticity of the cervical tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nulliparous cohort | – | Device: Pregnolia SystemCervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages. |
| Multiparous cohort | – | Device: Pregnolia SystemCervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women at gestational ages between 14+0 and 36+6 weeks.
Key inclusion criteria (6 listed)
- Informed Consent signed by the subject
- Pregnant woman
- Singleton pregnancy
- 18 years or older
- Nulliparous cohort: nulliparous pregnant woman
Key exclusion criteria (8 listed)
- Lack of informed consent
- Placenta praevia totalis with haemorrhage (irrespective of severity)
- Severe vaginal bleeding
- Rupture of membranes before 34 weeks (to be excluded with pH test)
- Visible tissue scarring at 12 o'clock position on cervix
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 |
|---|---|---|
| Pregnolia SystemThe cervical stiffness is measured with the Pregnolia System three times over a two-day period. | Device | Multiparous cohort, Nulliparous cohort |
Primary outcome
Cervical Stiffness Index
Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks
Cervical Stiffness Index (CSI, in mbar) measured repeatedly after 2 to 4 hours and approximately 24 hours at three different locations on the uterine cervix.
3 secondary outcomes
Cervical Stiffness Index (CSI, in mbar)
Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks
Elapsed time between
Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks
Device-related adverse events
Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervix; Pregnancy and Cervical Stiffness, run by Pregnolia AG at 1 site in Switzerland.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Stiffness Index (time frame: Measurements between 14+0 and 41+6 weeks gestational 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 29 Mar 2024; AzTrials last refreshed its copy on 28 Oct 2026.