Cervix; Pregnancy Clinical Trial
Official title:
Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System
Verified date | March 2024 |
Source | Pregnolia AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | December 17, 2023 |
Est. primary completion date | December 17, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital Frauenfeld | Frauenfeld |
Lead Sponsor | Collaborator |
---|---|
Pregnolia AG |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Cervical Stiffness Index (CSI, in mbar) | Measurements between 14+0 and 41+6 weeks gestational weeks | ||
Secondary | 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 | |
Secondary | Device-related adverse events | Device-related adverse events (incidence, severity, and seriousness) | Measurements between 14+0 and 41+6 weeks gestational weeks |
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