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The assessment of cervical stiffness plays a major role in obstetrics, for example to assess the risk of preterm birth.
The Pregnolia System is a CE-certified measuring device that objectively determines cervical stiffness using a slight negative pressure. The Pregnolia System was developed in Switzerland and resulted from a research project of the ETH and the University Hospital Zurich.
Until now, the stiffness of the cervix was examined and individually assessed by palpation (palpation with fingers). The Pregnolia System was developed to make this measurement objective and independent of the examining person.
The aim of the study is to measure cervical stiffness at different locations on the cervix to see if there are differences between the measurement locations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nulliparous cohort | Nulliparous pregnant woman |
| |
| Multiparous cohort | Multiparous pregnant woman |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnolia System | Device | Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Stiffness Index at 16+0 - 22+6 | Cervical Stiffness Index (CSI, in mbar) measured at 3 locations on the cervix (approximately 12, 4 and 8 o'clock, in a random order) at mid-pregnancy (16+0 - 22+6 gestational weeks). | 16+0 - 22+6 gestational weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Stiffness Index (repetition) | Cervical Stiffness Index (CSI, in mbar) measured 3 times at each location | 16+0 - 22+6 gestational weeks and optional follow-up visits |
| Cervical Stiffness Index (cohort) |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women at gestational ages between 16+0 - 22+6 weeks
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| gynosense AG | Uster | Switzerland | ||||
| University Hospital Zurich |
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Cervical Stiffness Index (CSI, in mbar) for each cohort.
| 16+0 - 22+6 gestational weeks and optional follow-up visits |
| Delivery data | Delivery data | 1-4 weeks after delivery or termination of the pregnancy |
| Zurich |
| Switzerland |