Pregnolia System Intra-observer Variability

Study Overview
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Brief Summary
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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.

Official Title
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Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System

Conditions
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Cervix; Pregnancy, Cervical Stiffness

Intervention / Treatment
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* Device: Pregnolia System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nulliparous cohort<br>Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages. | Device: Pregnolia System<br>* The cervical stiffness is measured with the Pregnolia System three times over a two-day period.<br>|
| Multiparous cohort<br>Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages. | Device: Pregnolia System<br>* The cervical stiffness is measured with the Pregnolia System three times over a two-day period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measurements between 14+0 and 41+6 weeks gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical Stiffness Index (CSI, in mbar) |  | 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 | Measurements between 14+0 and 41+6 weeks gestational weeks | 
| Device-related adverse events | Device-related adverse events (incidence, severity, and seriousness) | Measurements between 14+0 and 41+6 weeks gestational weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Stiffness, Intra-Observer Variability, Pregnolia System, Cervical Stiffness Index, CSI, Stiffness measurement