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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nulliparous cohort | Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages. |
| |
| Multiparous cohort | Cervical stiffness will be measured in the same subject sequentially between days and during the same day and at different gestational ages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnolia System | Device | The cervical stiffness is measured with the Pregnolia System three times over a two-day period. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women at gestational ages between 14+0 and 36+6 weeks.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Frauenfeld | Frauenfeld | 8501 | Switzerland |
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| 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 |