Cervical Stiffness, Cervix; Pregnancy
Conditions
Keywords
Cervical Stiffness, Intra-Observer Variability, Pregnolia System, Cervical Stiffness Index, CSI, Stiffness measurement
Brief 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. 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.
Interventions
DEVICEPregnolia System
The cervical stiffness is measured with the Pregnolia System three times over a two-day period.
Sponsors
Pregnolia AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed Consent signed by the subject * Pregnant woman * Singleton pregnancy * 18 years or older * Nulliparous cohort: nulliparous pregnant woman * Multiparous cohort: multiparous pregnant woman
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Stiffness Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Stiffness Index (CSI, in mbar) | Measurements between 14+0 and 41+6 weeks gestational weeks | — |
| Elapsed time between | Measurements between 14+0 and 41+6 weeks gestational weeks | The elapsed time between when the subject got out of bed until the measurements were taken |
| Device-related adverse events | Measurements between 14+0 and 41+6 weeks gestational weeks | Device-related adverse events (incidence, severity, and seriousness) |
Countries
Switzerland
Outcome results
None listed